WO2004000044A1 - Low-energy-diet - Google Patents
Low-energy-diet Download PDFInfo
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- WO2004000044A1 WO2004000044A1 PCT/DK2003/000424 DK0300424W WO2004000044A1 WO 2004000044 A1 WO2004000044 A1 WO 2004000044A1 DK 0300424 W DK0300424 W DK 0300424W WO 2004000044 A1 WO2004000044 A1 WO 2004000044A1
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- WO
- WIPO (PCT)
- Prior art keywords
- diet
- energy
- low
- protein
- diet according
- Prior art date
Links
- 235000005911 diet Nutrition 0.000 claims abstract description 56
- 230000037213 diet Effects 0.000 claims abstract description 55
- XEEYBQQBJWHFJM-UHFFFAOYSA-N Iron Chemical compound [Fe] XEEYBQQBJWHFJM-UHFFFAOYSA-N 0.000 claims abstract description 38
- 108090000623 proteins and genes Proteins 0.000 claims abstract description 37
- 102000004169 proteins and genes Human genes 0.000 claims abstract description 37
- 150000001720 carbohydrates Chemical class 0.000 claims abstract description 33
- 230000037323 metabolic rate Effects 0.000 claims abstract description 24
- 230000000694 effects Effects 0.000 claims abstract description 20
- 229910052742 iron Inorganic materials 0.000 claims abstract description 19
- 230000022558 protein metabolic process Effects 0.000 claims abstract description 16
- 235000018102 proteins Nutrition 0.000 claims description 36
- 239000004615 ingredient Substances 0.000 claims description 32
- 235000014633 carbohydrates Nutrition 0.000 claims description 31
- GNGACRATGGDKBX-UHFFFAOYSA-N dihydroxyacetone phosphate Chemical group OCC(=O)COP(O)(O)=O GNGACRATGGDKBX-UHFFFAOYSA-N 0.000 claims description 28
- 235000019197 fats Nutrition 0.000 claims description 26
- LCTONWCANYUPML-UHFFFAOYSA-M Pyruvate Chemical compound CC(=O)C([O-])=O LCTONWCANYUPML-UHFFFAOYSA-M 0.000 claims description 18
- 229940076788 pyruvate Drugs 0.000 claims description 18
- 235000016709 nutrition Nutrition 0.000 claims description 14
- 230000035764 nutrition Effects 0.000 claims description 14
- 239000000843 powder Substances 0.000 claims description 14
- 239000003795 chemical substances by application Substances 0.000 claims description 9
- 229910052500 inorganic mineral Inorganic materials 0.000 claims description 9
- 239000011707 mineral Substances 0.000 claims description 9
- FYYHWMGAXLPEAU-UHFFFAOYSA-N Magnesium Chemical compound [Mg] FYYHWMGAXLPEAU-UHFFFAOYSA-N 0.000 claims description 8
- 239000011777 magnesium Substances 0.000 claims description 8
- 229910052749 magnesium Inorganic materials 0.000 claims description 8
- 230000007246 mechanism Effects 0.000 claims description 8
- 230000009467 reduction Effects 0.000 claims description 8
- 230000036186 satiety Effects 0.000 claims description 8
- 235000019627 satiety Nutrition 0.000 claims description 8
- 235000013325 dietary fiber Nutrition 0.000 claims description 6
- 230000017854 proteolysis Effects 0.000 claims description 6
- DAEPDZWVDSPTHF-UHFFFAOYSA-M sodium pyruvate Chemical compound [Na+].CC(=O)C([O-])=O DAEPDZWVDSPTHF-UHFFFAOYSA-M 0.000 claims description 6
- RUDATBOHQWOJDD-UHFFFAOYSA-N (3beta,5beta,7alpha)-3,7-Dihydroxycholan-24-oic acid Natural products OC1CC2CC(O)CCC2(C)C2C1C1CCC(C(CCC(O)=O)C)C1(C)CC2 RUDATBOHQWOJDD-UHFFFAOYSA-N 0.000 claims description 5
- 239000005018 casein Substances 0.000 claims description 5
- BECPQYXYKAMYBN-UHFFFAOYSA-N casein, tech. Chemical compound NCCCCC(C(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(CC(C)C)N=C(O)C(CCC(O)=O)N=C(O)C(CC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(C(C)O)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=N)N=C(O)C(CCC(O)=O)N=C(O)C(CCC(O)=O)N=C(O)C(COP(O)(O)=O)N=C(O)C(CCC(O)=N)N=C(O)C(N)CC1=CC=CC=C1 BECPQYXYKAMYBN-UHFFFAOYSA-N 0.000 claims description 5
- 235000021240 caseins Nutrition 0.000 claims description 5
- 235000021323 fish oil Nutrition 0.000 claims description 5
- RUDATBOHQWOJDD-UZVSRGJWSA-N ursodeoxycholic acid Chemical compound C([C@H]1C[C@@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)CC1 RUDATBOHQWOJDD-UZVSRGJWSA-N 0.000 claims description 5
- 229960001661 ursodiol Drugs 0.000 claims description 5
- BVKZGUZCCUSVTD-UHFFFAOYSA-M Bicarbonate Chemical compound OC([O-])=O BVKZGUZCCUSVTD-UHFFFAOYSA-M 0.000 claims description 4
- 108010073771 Soybean Proteins Proteins 0.000 claims description 4
- 239000007788 liquid Substances 0.000 claims description 4
- 238000004519 manufacturing process Methods 0.000 claims description 4
- 229940001941 soy protein Drugs 0.000 claims description 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 4
- 240000005979 Hordeum vulgare Species 0.000 claims description 3
- 235000007340 Hordeum vulgare Nutrition 0.000 claims description 3
- 229940018333 calcium pyruvate Drugs 0.000 claims description 3
- UZWMCCLZMHPPKW-UHFFFAOYSA-L calcium;2-oxopropanoate Chemical compound [Ca+2].CC(=O)C([O-])=O.CC(=O)C([O-])=O UZWMCCLZMHPPKW-UHFFFAOYSA-L 0.000 claims description 3
- 238000000034 method Methods 0.000 claims description 3
- 229940054269 sodium pyruvate Drugs 0.000 claims description 3
- 235000013336 milk Nutrition 0.000 claims description 2
- 239000008267 milk Substances 0.000 claims description 2
- 210000004080 milk Anatomy 0.000 claims description 2
- 235000019895 oat fiber Nutrition 0.000 claims description 2
- 235000015277 pork Nutrition 0.000 claims description 2
- 229940057917 medium chain triglycerides Drugs 0.000 abstract description 2
- 239000000203 mixture Substances 0.000 description 14
- 230000004580 weight loss Effects 0.000 description 14
- 238000009472 formulation Methods 0.000 description 11
- 206010033307 Overweight Diseases 0.000 description 9
- 230000037081 physical activity Effects 0.000 description 9
- 230000001603 reducing effect Effects 0.000 description 7
- 239000000047 product Substances 0.000 description 6
- 229940077676 low-energy diet formulations for treatment of obesity Drugs 0.000 description 5
- IJGRMHOSHXDMSA-UHFFFAOYSA-N Atomic nitrogen Chemical compound N#N IJGRMHOSHXDMSA-UHFFFAOYSA-N 0.000 description 4
- 230000037396 body weight Effects 0.000 description 4
- 235000013861 fat-free Nutrition 0.000 description 4
- 239000008371 vanilla flavor Substances 0.000 description 4
- 239000011782 vitamin Substances 0.000 description 4
- 235000013343 vitamin Nutrition 0.000 description 4
- 229940088594 vitamin Drugs 0.000 description 4
- 229930003231 vitamin Natural products 0.000 description 4
- 239000013585 weight reducing agent Substances 0.000 description 4
- WRIDQFICGBMAFQ-UHFFFAOYSA-N (E)-8-Octadecenoic acid Natural products CCCCCCCCCC=CCCCCCCC(O)=O WRIDQFICGBMAFQ-UHFFFAOYSA-N 0.000 description 3
- LQJBNNIYVWPHFW-UHFFFAOYSA-N 20:1omega9c fatty acid Natural products CCCCCCCCCCC=CCCCCCCCC(O)=O LQJBNNIYVWPHFW-UHFFFAOYSA-N 0.000 description 3
- QSBYPNXLFMSGKH-UHFFFAOYSA-N 9-Heptadecensaeure Natural products CCCCCCCC=CCCCCCCCC(O)=O QSBYPNXLFMSGKH-UHFFFAOYSA-N 0.000 description 3
- 239000005642 Oleic acid Substances 0.000 description 3
- ZQPPMHVWECSIRJ-UHFFFAOYSA-N Oleic acid Natural products CCCCCCCCC=CCCCCCCCC(O)=O ZQPPMHVWECSIRJ-UHFFFAOYSA-N 0.000 description 3
- 201000001883 cholelithiasis Diseases 0.000 description 3
- 208000001130 gallstones Diseases 0.000 description 3
- QXJSBBXBKPUZAA-UHFFFAOYSA-N isooleic acid Natural products CCCCCCCC=CCCCCCCCCC(O)=O QXJSBBXBKPUZAA-UHFFFAOYSA-N 0.000 description 3
- 210000003127 knee Anatomy 0.000 description 3
- 230000004060 metabolic process Effects 0.000 description 3
- ZQPPMHVWECSIRJ-KTKRTIGZSA-N oleic acid Chemical compound CCCCCCCC\C=C/CCCCCCCC(O)=O ZQPPMHVWECSIRJ-KTKRTIGZSA-N 0.000 description 3
- 208000010444 Acidosis Diseases 0.000 description 2
- 208000007976 Ketosis Diseases 0.000 description 2
- 230000007950 acidosis Effects 0.000 description 2
- 208000026545 acidosis disease Diseases 0.000 description 2
- 206010003119 arrhythmia Diseases 0.000 description 2
- 230000006793 arrhythmia Effects 0.000 description 2
- 230000008859 change Effects 0.000 description 2
- 230000003247 decreasing effect Effects 0.000 description 2
- RXKJFZQQPQGTFL-UHFFFAOYSA-N dihydroxyacetone Chemical compound OCC(=O)CO RXKJFZQQPQGTFL-UHFFFAOYSA-N 0.000 description 2
- 239000000835 fiber Substances 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 235000006796 hypocaloric diet Nutrition 0.000 description 2
- 230000004140 ketosis Effects 0.000 description 2
- 235000012054 meals Nutrition 0.000 description 2
- 229910052757 nitrogen Inorganic materials 0.000 description 2
- 235000015097 nutrients Nutrition 0.000 description 2
- 238000001543 one-way ANOVA Methods 0.000 description 2
- 238000007427 paired t-test Methods 0.000 description 2
- 230000001737 promoting effect Effects 0.000 description 2
- 230000000241 respiratory effect Effects 0.000 description 2
- 230000004044 response Effects 0.000 description 2
- 230000000276 sedentary effect Effects 0.000 description 2
- IIZPXYDJLKNOIY-JXPKJXOSSA-N 1-palmitoyl-2-arachidonoyl-sn-glycero-3-phosphocholine Chemical compound CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCC\C=C/C\C=C/C\C=C/C\C=C/CCCCC IIZPXYDJLKNOIY-JXPKJXOSSA-N 0.000 description 1
- 206010006956 Calcium deficiency Diseases 0.000 description 1
- KRKNYBCHXYNGOX-UHFFFAOYSA-K Citrate Chemical compound [O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O KRKNYBCHXYNGOX-UHFFFAOYSA-K 0.000 description 1
- 235000020881 DASH diet Nutrition 0.000 description 1
- 235000019739 Dicalciumphosphate Nutrition 0.000 description 1
- 239000005715 Fructose Substances 0.000 description 1
- 229930091371 Fructose Natural products 0.000 description 1
- RFSUNEUAIZKAJO-ARQDHWQXSA-N Fructose Chemical compound OC[C@H]1O[C@](O)(CO)[C@@H](O)[C@@H]1O RFSUNEUAIZKAJO-ARQDHWQXSA-N 0.000 description 1
- 206010022971 Iron Deficiencies Diseases 0.000 description 1
- 208000003947 Knee Osteoarthritis Diseases 0.000 description 1
- 208000008167 Magnesium Deficiency Diseases 0.000 description 1
- 206010028391 Musculoskeletal Pain Diseases 0.000 description 1
- 208000008589 Obesity Diseases 0.000 description 1
- AUYYCJSJGJYCDS-LBPRGKRZSA-N Thyrolar Chemical class IC1=CC(C[C@H](N)C(O)=O)=CC(I)=C1OC1=CC=C(O)C(I)=C1 AUYYCJSJGJYCDS-LBPRGKRZSA-N 0.000 description 1
- 102000004338 Transferrin Human genes 0.000 description 1
- 108090000901 Transferrin Proteins 0.000 description 1
- 240000008042 Zea mays Species 0.000 description 1
- 235000005824 Zea mays ssp. parviglumis Nutrition 0.000 description 1
- 235000002017 Zea mays subsp mays Nutrition 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000011575 calcium Substances 0.000 description 1
- 239000001506 calcium phosphate Substances 0.000 description 1
- 235000019577 caloric intake Nutrition 0.000 description 1
- 238000007707 calorimetry Methods 0.000 description 1
- 150000003943 catecholamines Chemical class 0.000 description 1
- 235000005822 corn Nutrition 0.000 description 1
- NEFBYIFKOOEVPA-UHFFFAOYSA-K dicalcium phosphate Chemical compound [Ca+2].[Ca+2].[O-]P([O-])([O-])=O NEFBYIFKOOEVPA-UHFFFAOYSA-K 0.000 description 1
- 229940038472 dicalcium phosphate Drugs 0.000 description 1
- 229910000390 dicalcium phosphate Inorganic materials 0.000 description 1
- 230000000378 dietary effect Effects 0.000 description 1
- 235000015872 dietary supplement Nutrition 0.000 description 1
- 229940120503 dihydroxyacetone Drugs 0.000 description 1
- 231100000673 dose–response relationship Toxicity 0.000 description 1
- 239000003792 electrolyte Substances 0.000 description 1
- -1 energy utilization Substances 0.000 description 1
- 230000002349 favourable effect Effects 0.000 description 1
- 239000000796 flavoring agent Substances 0.000 description 1
- 235000019634 flavors Nutrition 0.000 description 1
- 230000002401 inhibitory effect Effects 0.000 description 1
- 235000020796 iron status Nutrition 0.000 description 1
- 239000000787 lecithin Substances 0.000 description 1
- 229940067606 lecithin Drugs 0.000 description 1
- 235000010445 lecithin Nutrition 0.000 description 1
- 235000020845 low-calorie diet Nutrition 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 229910000402 monopotassium phosphate Inorganic materials 0.000 description 1
- 235000019796 monopotassium phosphate Nutrition 0.000 description 1
- 235000020824 obesity Nutrition 0.000 description 1
- 235000019198 oils Nutrition 0.000 description 1
- 201000008482 osteoarthritis Diseases 0.000 description 1
- GNSKLFRGEWLPPA-UHFFFAOYSA-M potassium dihydrogen phosphate Chemical compound [K+].OP(O)([O-])=O GNSKLFRGEWLPPA-UHFFFAOYSA-M 0.000 description 1
- LWIHDJKSTIGBAC-UHFFFAOYSA-K potassium phosphate Substances [K+].[K+].[K+].[O-]P([O-])([O-])=O LWIHDJKSTIGBAC-UHFFFAOYSA-K 0.000 description 1
- 230000029219 regulation of pH Effects 0.000 description 1
- 230000029058 respiratory gaseous exchange Effects 0.000 description 1
- 239000007787 solid Substances 0.000 description 1
- 230000003019 stabilising effect Effects 0.000 description 1
- 230000002195 synergetic effect Effects 0.000 description 1
- 239000006188 syrup Substances 0.000 description 1
- 235000020357 syrup Nutrition 0.000 description 1
- 239000005495 thyroid hormone Substances 0.000 description 1
- 229940036555 thyroid hormone Drugs 0.000 description 1
- 239000012581 transferrin Substances 0.000 description 1
- 235000021122 unsaturated fatty acids Nutrition 0.000 description 1
- 150000004670 unsaturated fatty acids Chemical class 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/20—Reducing nutritive value; Dietetic products with reduced nutritive value
-
- A—HUMAN NECESSITIES
- A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
- A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
- A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
- A23L33/30—Dietetic or nutritional methods, e.g. for losing weight
Definitions
- the present invention relates to a low-energy diet (LED) having effect on the basal metabolic rate, the protein metabolism and/or the energy expenditure.
- LED low-energy diet
- Low-energy-diets are known from the prior art, for example EP 425 423 presents a low-energy-diet wherein specific fat, carbohydrate and protein sources are used.
- the low-energy-diets known either simply offer fewer calories than normal daily cost, or focus on one mechanism of losing weight.
- the present invention relates to a low-energy-diet having several improvements in relation to prior art diets.
- the present diet is capable of increasing satiety yet providing weight loss. Furthermore, the diet maintains fat-free body mass, increases the energy expenditure, re-loses or eliminates risk of iron deficiency, as well as magnesium and calcium deficiency.
- the diet also prevents heart arrhythmias and gall stones.
- the present invention relates to a low-energy-diet comprising as ingredients sources of
- the low-energy-diet is in particular intended for use as the main or sole nutrition in the treatment of overweight, by for example replacing one or more, or all of the daily meals of an individual being obese. But the diet may of course also be used as a nutritional supplement.
- the invention in another aspect relates to a method for treating overweight comprising administering to an individual in need thereof an effective amount of a low- energy-diet as defined above as the main or sole nutrition daily, in particular the low- energy-diet is suitable for treatment of severe overweight also called obesity.
- overweight is defined as a Body mass Index > 25kg/m 2 .
- severe overweight is defined as a body mass Index > 30 kg/m 2 .
- the invention relates to the use of ingredients being sources of
- SE Least Squares Means
- daily amounts In the present context the amounts of ingredients in the low-energy- diet is given as daily doses, i.e. for example as mg/d. Since the low-energy-diet may be divided into two or more doses per day, the amount of the various ingredients are calculated on basis of the total low-energy-diet per day.
- Low-energy-diets administered to treat overweight are often taken for a long period of time, and therefore it is of importance that basal metabolic rate as well as protein metabolism is only mildly affected by the diet, if at all effected, so that the metabolism is stabilised although an individual to lose weight administer the low-energy-diet as main or sole nutrition for weeks or months.
- the ingredients having effect on the basal metabolic rate are capable of inhibiting the basal metabolic rate from decreasing.
- the ingredients having effect on the protein metabolism are preferably capable of reducing protein degradation.
- ingredients having effect on energy expenditure are preferably capable of increasing the energy expenditure.
- the diet is a balance between offering sufficiently low amount of energy and at the same time offering satiety suffi- ciently high to maintain the individual losing weight to follow the instructions of the diet.
- the diet preferably has an energy content in the range of from 600 kcal/d to 1200 kcal/d, such as an energy content of approximately 800 kcal/d.
- Basal metabolic rate preferably has an energy content in the range of from 600 kcal/d to 1200 kcal/d, such as an energy content of approximately 800 kcal/d.
- the normal response in the body is to lower the basal metabolic rate, due to the lower level of energy supply.
- this normal reduction in the basal metabolic rate counteracts to some extent the effect of less energy intake. Accordingly, it is an object of the invention to prevent reduction in the basal metabolic rate.
- this is accomplished by providing an iron content in the low- energy-diet, wherein said iron content is sufficient to prevent reduction in the basal metabolic rate, as discussed below.
- Basal metabolic rate may be measured by indirect calometry either by a ventilated hood system or by use of respiration chambers.
- the effect of an ingredient on the protein metabolism may be measured as the effect on the nitrogen metabolism, for example as described in Stanko et al. "Body composition, energy utilization, and nitrogen metabolism with a severely restricted diet supplemented with dihydroxyacetone and pyruvate", Am J Clin Nutr (1992) 55, 771 -6, hereby incorporated by reference.
- the ingredient capable of reducing or eliminating the protein loss preferably is an ingredient capable of reducing the acidosis following ketosis, thereby reducing the protein degradation, and as effect affecting the protein metabolism.
- the low-energy-diet according to the invention preferably comprises a pH-regulating agent in an amount sufficient to reduce protein degradation.
- the pH-regulating agent is bicarbonate in an amount sufficient to reduce protein degradation, such as bicarbonate in an amount of from 50 mmol/d to 70 mmol/d.
- the protein content of the low-energy diet is preferably given in the amounts recommended by the health authorities.
- the protein source is preferably a source of proteins having a great bio-availability.
- the source of protein is preferably selected from casein, pork protein, and/or soy protein.
- the source of protein is soy protein.
- the protein content is preferably in an amount of from 60 g protein to 75 g protein, such as about 70 g protein.
- Daily energy expenditure may be measured by indirect calorimetry during stay in a respiratory chamber as described in Dulloo et al. "Twenty-four-hour energy expenditure and urinary catecholamines of humans consuming low-to-moderate amounts of medium-chain triglyeerides: a dose-response study in a human respiratory cham- ber, European Journal of Clinical Nutrition (1996) 50, 152-158, hereby incorporated by reference.
- the low-energy-diet preferably also comprises at least one ingredient capable of increasing the energy expenditure.
- This ingredient may be selected from one or more of the following:
- the low-energy-diet according to the invention preferably comprises as at least a part of the carbohydrate source dihydroxy acetone phosphate and/or pyruvate.
- the dihydroxy acetone phosphate and/or pyruvate is preferably in an amount sufficient to increase the energy expenditure whether administered together or alone. Therefore, the diet preferably comprises dihydroxy acetone phosphate in an amount of from 5 g to 15 g, such as in an amount of from 10 g to 15 g. In another embodiment the diet preferably comprises pyruvate in an amount of from 5 g to 20 g, such as in an amount of from 10 g to 20 g.
- dihydroxy acetone phosphate and pyruvate may also be administered when the two ingredients both are administered in the low-energy-diet.
- the pyruvate preferably is in the form of sodium pyruvate and/or calcium pyruvate, for example as about 10 g of sodium pyruvate and 9 g of calcium pyruvate.
- carbohydrate sources are also included in the low-energy-diet.
- Any suitable carbohydrate source may be used, for example fructose.
- the low-energy-diet according to the invention preferably comprises the total carbo- hydrate source in an amount of from 70 g carbohydrate to 120 g carbohydrate, more preferably in an amount of from 80 g carbohydrate to 110 g carbohydrate.
- Fat preferably comprises the total carbo- hydrate source in an amount of from 70 g carbohydrate to 120 g carbohydrate, more preferably in an amount of from 80 g carbohydrate to 110 g carbohydrate.
- medium chain triglyeerides as discussed above, said medium chain triglyeerides preferably being selected from C6 triglyeerides, C8 triglyeerides and C10 triglyeerides.
- the medium chain triglyeerides preferably constitute at least 3 g of the fat source.
- the remaining fat in the fat source is preferably unsaturated fatty acids, such as oleic acid.
- the low-energy-diet may comprise fish oil, such as at least 1 g of fish oil, such as at least 3 g of fish oil, such as at least 5 g of fish oil.
- the low-energy-diet according to the invention comprises iron in an amount sufficient to modulate the basal metabolic rate, such as sufficient to prevent reduction in the basal metabolic rate.
- the effect of iron intake during weight loss is described.
- the saturation of trans- ferrin is increased when the iron intake is increased to above the recommended daily allowance (RDA) leading to a reduced decrease in the thyroid hormone T 3 level.
- RDA recommended daily allowance
- At least 2 mg/d iron above RDA should be included in the low- energy-diet, such as at least 5 mg/day iron above RDA. Most preferably about
- the low-energy-diet according to the invention preferably comprises iron in an amount of from 20 mg/d to 30 mg/d. Satiety
- the low-energy-diet should preferably also provide the individual subjected to the low-energy-diet with a feeling of satiety each time the doses of low-energy-diet is taken. Thereby the probability of success of losing weight rapidly increases.
- ingredients, dihydroxy acetone phosphate, pyruvate and medium chain triglyce- rides, capable of increasing the energy expenditure may additionally have the effect of providing satiety.
- the low-energy-diet according to the invention may further comprise dietary fibres, among others also to increase the feeling of satiety.
- the dietary fibres may be any suitable dietary fibres, such as fibres are selected from barley fibres, sugar beat fibres, and oat fibres or combinations thereof.
- the amount of fibre is preferably in an amount of from 10 g/d to 50 g/d.
- the diet comprises magnesium, such as magnesium added as MgCI, preferably in an amount of from 15 mEq/d to 20 mEq/d, preferably about 18 mEq/d.
- the diet further comprises ursodeoxy cholic acid to reduce the risk of gall stones.
- ursodeoxy cholic acid is administered separately as a tablet.
- the ursodeoxy cholic acid is preferably administered in an amount of from 1000 mg/d to 1400 mg/d, preferably about 1200 mg/d.
- Vitamins and minerals not mentioned above are dosed within the limits laid down by the health authorities, and may be included in the low-energy-diet or administered daily in tablet form. In particular vitamins and minerals are dosed according to Dietary Reference Intakes, Institute of medicine, USA, with modifications according to special requirements for overweight subjects on a low-calorie diet.
- Carbohydrate 70-120 g, including dihydroxy acetone phosphate 10-15g and/or pyruvate 10-20 g Protein: 50-80 g Fat: 5-20 g, including at least 3 g medium chain triglyeerides
- Fat 5-20 g, including at least 4 g medium chain triglyeerides
- the low-energy-diet according to the invention comprises per day
- Carbohydrate 70-120 g, including dihydroxy acetone phosphate 10-15g and/or py- ruvate 10-20 g Protein: 50-80 g
- Fat 5-20 g, including at least 3 g medium chain triglyeerides Iron: 20-30 mg/d Magnesium: 15-20 mEq/d
- Carbohydrate 70-120 g, including dihydroxy acetone phosphate 10-15g and/or py- ruvate 10-20 g
- Fat 5-20 g, including at least 3 g medium chain triglyeerides
- the low-energy-diet according to the present invention may be formulated into any suitable form, such as powders, or ready-to-drink or ready-to-eat products. Thereby the individuals desiring to lose weight may adapt more to the diet, since they have a choice between various products.
- the low-energy-diet is in the form of powder.
- Said powder may be dispensed in separate doses and suspended or solved in liquid, such as liquid selected from water and milk immediately before intake.
- the low-energy-diet according to the invention is in particular meant for use in the treatment of overweight. Accordingly, the present invention further relates to a method for treating overweight comprising administering to an individual in need thereof an effective amount of a low-energy-diet as defined above as the main or sole nutrition daily.
- the diet is preferably divided into two or more portions per day to be administered at regular times for, for example to simulate the traditional meal times.
- Another aspect of the invention relates to the use of ingredients being sources of
- the ingredients mentioned may be as described above.
- the diet is preferably packed in a package intended for being able to cover the total nourishment requirement for a defined period of time, such as packages for a pow- der, a ready-to-drink product or a bar product.
- Carbohydrate 96 g, including pyruvate 10 g Protein (soy and casein): 70 g Fat (oleic acid): 15 g Fibres (barley): 15 g/d
- Vitamins and minerals according to Nordis Alimantaris Plus extra addition of iron 16 g
- Carbohydrate including pyruvate (10% of total) 6.8
- a powder formulation consisting of the ingredients of table 1 were produced by mixing the ingredients and homogenising the powder.
- Body mass index (kg/m2) -2.7 (-3.7 - -1.6)a -2.3 (-2.7 - -1.9)a 0.134
- Obese patients with knee OA are encouraged to reduce their body weight. Because of the musculoskeletal pain associated with physical activity among obese patients with knee OA, most of these patients lead a sedentary life with little exercise. A dietary approach to diminish the weight will be beneficial for the patients in several aspects including a reduced load on the weight bearing joints.
- Speasy ® from NutriCare A/S having the formulation of Example 4 provided the subjects with 3.4 MJ/day (810 kcal): 37 E% from protein, 47 E% from carbohydrate and 16 E% from fat.
- BMI Body mass index
- the LED showed a better weight reducing property, with a more favorable effect on body composition than a conventional hypocaloric diet after 8 weeks intervention.
- the results of this study demonstrate the possibility of reducing weight in elderly, sedentary patients, without loss of excessive lean body mass.
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Abstract
The invention relates to a low-energy diet (LED) having effect on the basal metabolic rate, the protein metabolism and/or the energy expenditure, such as a low-energy-diet comprising Carbohydrate: 70-120 g, Protein: 50-80 g, Fat: 5-20 g, including medium chain triglycerides, and Iron: 20-30 mg/d, wherein the carbohydrate source and/or the fat source may increase the energy expenditure.
Description
Low-energy-diet
Field of invention
The present invention relates to a low-energy diet (LED) having effect on the basal metabolic rate, the protein metabolism and/or the energy expenditure.
All patent and non-patent references cited in the application, or in the present application, are also hereby incorporated by reference in their entirety.
Background of invention
Low-energy-diets are known from the prior art, for example EP 425 423 presents a low-energy-diet wherein specific fat, carbohydrate and protein sources are used. However, the low-energy-diets known either simply offer fewer calories than normal daily cost, or focus on one mechanism of losing weight.
Summary of invention
The present invention relates to a low-energy-diet having several improvements in relation to prior art diets.
The present diet is capable of increasing satiety yet providing weight loss. Furthermore, the diet maintains fat-free body mass, increases the energy expenditure, re- duces or eliminates risk of iron deficiency, as well as magnesium and calcium deficiency.
In a preferred embodiment the diet also prevents heart arrhythmias and gall stones.
Accordingly, the present invention relates to a low-energy-diet comprising as ingredients sources of
protein, carbohydrate, fat, and optionally minerals and pH-regulating agents, wherein one or more of the ingredient(s) has effect on at least two of the follow- ing mechanisms
the basal metabolic rate, and/or the protein metabolism, and /or the energy expenditure,
when the low-energy-diet is administered as the main or sole nutrition.
The low-energy-diet is in particular intended for use as the main or sole nutrition in the treatment of overweight, by for example replacing one or more, or all of the daily meals of an individual being obese. But the diet may of course also be used as a nutritional supplement.
In another aspect the invention relates to a method for treating overweight comprising administering to an individual in need thereof an effective amount of a low- energy-diet as defined above as the main or sole nutrition daily, in particular the low- energy-diet is suitable for treatment of severe overweight also called obesity.
in the present context "overweight" is defined as a Body mass Index > 25kg/m2. "Severe overweight" is defined as a body mass Index > 30 kg/m2.
Furthermore, the invention relates to the use of ingredients being sources of
protein, carbohydrate, fat, and optionally minerals and pH-regulating agents, wherein one or more of the ingredient(s) has effect on at least two of the follow- ing mechanisms
the basal metabolic rate, and/or the protein metabolism, and /or the energy utilization,
for the production of a low-energy-diet for administration as the main or sole nutrition.
Drawings
Fig 1. Least Squares Means (SE) body weight of subjects during weight reduction by either high (black triangle, n=19) or low physical activity (open triangle, n=22), and the overall mean values ( — , n=41 ). There were no differences between interventions, thus a significant effect of time (trend, P<0.0001 ), with an overall slope β(95% confidence limits): β = -1.08 kg/week (-1.22~ -0.95).
Fig. 2. Percentage weight loss during 7 weeks intervention using Speasy® as the only nutrient. Values are Least Squares Means (95% confidence limits ( — )) n=41 observations. Trend P<0.0001 ; Slope β (95% confidence limit): β = 1.186 %weight loss/week (1.063 - 1.309).
Detailed description of the invention
Definitions
Daily amounts: In the present context the amounts of ingredients in the low-energy- diet is given as daily doses, i.e. for example as mg/d. Since the low-energy-diet may be divided into two or more doses per day, the amount of the various ingredients are calculated on basis of the total low-energy-diet per day.
It is an object of the present invention to provide a diet having an improved profile as compared to prior art diets in respect of at least the following parameters: satiety weight loss maintaining fat-free body mass increase in energy expenditure
This is obtained by using ingredients in the low-energy-diet that is capable of, preferably in a synergistic manner, to have effect on at least two of the following mechanisms
the basal metabolic rate, and/or the protein metabolism, and /or
the energy expenditure,
when the low-energy-diet is administered as the main or sole nutrition.
In a preferred embodiment the low-energy-diet is capable of having effect on all three of the following mechanisms
the basal metabolic rate, the protein metabolism, the energy expenditure,
when the low-energy-diet is administered as the main or sole nutrition.
Low-energy-diets administered to treat overweight are often taken for a long period of time, and therefore it is of importance that basal metabolic rate as well as protein metabolism is only mildly affected by the diet, if at all effected, so that the metabolism is stabilised although an individual to lose weight administer the low-energy-diet as main or sole nutrition for weeks or months. Thus, it is preferred that the ingredients having effect on the basal metabolic rate are capable of inhibiting the basal metabolic rate from decreasing. The ingredients having effect on the protein metabolism are preferably capable of reducing protein degradation.
Furthermore, the ingredients having effect on energy expenditure are preferably capable of increasing the energy expenditure.
Energy content
In any diet form aiming at promoting weight loss, the diet is a balance between offering sufficiently low amount of energy and at the same time offering satiety suffi- ciently high to maintain the individual losing weight to follow the instructions of the diet.
In the present invention, the diet preferably has an energy content in the range of from 600 kcal/d to 1200 kcal/d, such as an energy content of approximately 800 kcal/d.
Basal metabolic rate
During a diet, in particular a low-energy-diet, the normal response in the body, is to lower the basal metabolic rate, due to the lower level of energy supply. However, when aiming at losing weight this normal reduction in the basal metabolic rate counteracts to some extent the effect of less energy intake. Accordingly, it is an object of the invention to prevent reduction in the basal metabolic rate.
In one embodiment this is accomplished by providing an iron content in the low- energy-diet, wherein said iron content is sufficient to prevent reduction in the basal metabolic rate, as discussed below.
Basal metabolic rate may be measured by indirect calometry either by a ventilated hood system or by use of respiration chambers.
Protein metabolism
Normal metabolic responses to low-energy-diet are ketosis followed by acidosis leading to protein loss. According to the present invention, it is preferred to supply proteins in the diet, and also to supply with an ingredient capable of reducing or eliminating the protein loss, normally seen in individuals subjected to low-energy- diets.
The effect of an ingredient on the protein metabolism may be measured as the effect on the nitrogen metabolism, for example as described in Stanko et al. "Body composition, energy utilization, and nitrogen metabolism with a severely restricted diet supplemented with dihydroxyacetone and pyruvate", Am J Clin Nutr (1992) 55, 771 -6, hereby incorporated by reference.
The ingredient capable of reducing or eliminating the protein loss, preferably is an ingredient capable of reducing the acidosis following ketosis, thereby reducing the protein degradation, and as effect affecting the protein metabolism.
pH regulation
One such protein metabolism effecting ingredient is this a pH-regulating ingredient. Accordingly, the low-energy-diet according to the invention preferably comprises a pH-regulating agent in an amount sufficient to reduce protein degradation. In a preferred embodiment the pH-regulating agent is bicarbonate in an amount sufficient to reduce protein degradation, such as bicarbonate in an amount of from 50 mmol/d to 70 mmol/d.
Protein
The protein content of the low-energy diet is preferably given in the amounts recommended by the health authorities. The protein source is preferably a source of proteins having a great bio-availability.
Thus, the source of protein is preferably selected from casein, pork protein, and/or soy protein. In a preferred embodiment at least a portion of the source of protein is soy protein.
In the low-energy-diet having a energy content of about 600 kcal/d to 1200 kcal/d the protein content is preferably in an amount of from 60 g protein to 75 g protein, such as about 70 g protein.
Energy expenditure
Daily energy expenditure may be measured by indirect calorimetry during stay in a respiratory chamber as described in Dulloo et al. "Twenty-four-hour energy expenditure and urinary catecholamines of humans consuming low-to-moderate amounts of medium-chain triglyeerides: a dose-response study in a human respiratory cham- ber, European Journal of Clinical Nutrition (1996) 50, 152-158, hereby incorporated by reference.
In order to promote the desired weight loss in individuals subjected to the low- energy diet, the low-energy-diet preferably also comprises at least one ingredient capable of increasing the energy expenditure.
This ingredient may be selected from one or more of the following:
Dihydroxy acetone phosphate, pyruvate, as well as medium chain triglyeerides.
Accordingly, the low-energy-diet according to the invention preferably comprises as at least a part of the carbohydrate source dihydroxy acetone phosphate and/or pyruvate.
The dihydroxy acetone phosphate and/or pyruvate is preferably in an amount sufficient to increase the energy expenditure whether administered together or alone. Therefore, the diet preferably comprises dihydroxy acetone phosphate in an amount of from 5 g to 15 g, such as in an amount of from 10 g to 15 g. In another embodiment the diet preferably comprises pyruvate in an amount of from 5 g to 20 g, such as in an amount of from 10 g to 20 g.
The same amounts of dihydroxy acetone phosphate and pyruvate may also be administered when the two ingredients both are administered in the low-energy-diet.
The pyruvate preferably is in the form of sodium pyruvate and/or calcium pyruvate, for example as about 10 g of sodium pyruvate and 9 g of calcium pyruvate.
Carbohydrate
In addition to the carbohydrates given as pyruvate and dihydroxy acetone phosphate other sources of carbohydrate are also included in the low-energy-diet. Any suitable carbohydrate source may be used, for example fructose.
The low-energy-diet according to the invention preferably comprises the total carbo- hydrate source in an amount of from 70 g carbohydrate to 120 g carbohydrate, more preferably in an amount of from 80 g carbohydrate to 110 g carbohydrate.
Fat
Another ingredient capable of promoting the energy expenditure is medium chain triglyeerides as discussed above, said medium chain triglyeerides preferably being selected from C6 triglyeerides, C8 triglyeerides and C10 triglyeerides.
Of the preferred amount of fat source in the low-energy-diet according to the invention in an amount of from 5 g to 20 g, the medium chain triglyeerides preferably constitute at least 3 g of the fat source.
The remaining fat in the fat source is preferably unsaturated fatty acids, such as oleic acid.
Also, the low-energy-diet may comprise fish oil, such as at least 1 g of fish oil, such as at least 3 g of fish oil, such as at least 5 g of fish oil.
Iron content
In a preferred embodiment the low-energy-diet according to the invention comprises iron in an amount sufficient to modulate the basal metabolic rate, such as sufficient to prevent reduction in the basal metabolic rate. In Beard et al. "Changes in iron status during weight loss with very-low-energy diets" Am J Clin Nutr (1997) 66, 104- 10 the effect of iron intake during weight loss is described. The saturation of trans- ferrin is increased when the iron intake is increased to above the recommended daily allowance (RDA) leading to a reduced decrease in the thyroid hormone T3 level. Thereby the reduction in basal metabolic rate normally seen in individuals during a diet, in particular a low-energy-diet is reduced or even eliminated.
It is preferred that at least 2 mg/d iron above RDA should be included in the low- energy-diet, such as at least 5 mg/day iron above RDA. Most preferably about
9 mg/d iron above RDA should be included in the low-energy-diet. In other words, the low-energy-diet according to the invention preferably comprises iron in an amount of from 20 mg/d to 30 mg/d.
Satiety
Apart from stabilising the basal metabolic rate and the protein metabolism and increasing the energy expenditure, the low-energy-diet should preferably also provide the individual subjected to the low-energy-diet with a feeling of satiety each time the doses of low-energy-diet is taken. Thereby the probability of success of losing weight rapidly increases.
The ingredients, dihydroxy acetone phosphate, pyruvate and medium chain triglyce- rides, capable of increasing the energy expenditure may additionally have the effect of providing satiety.
Dietary fibres
In addition to the ingredients mentioned above, the low-energy-diet according to the invention may further comprise dietary fibres, among others also to increase the feeling of satiety.
The dietary fibres may be any suitable dietary fibres, such as fibres are selected from barley fibres, sugar beat fibres, and oat fibres or combinations thereof.
Independent of the fibre used, the amount of fibre is preferably in an amount of from 10 g/d to 50 g/d.
Magnesium
In order to avoid disturbances in the electrolytes leading to heart arrhythmias it is further preferred that the diet comprises magnesium, such as magnesium added as MgCI, preferably in an amount of from 15 mEq/d to 20 mEq/d, preferably about 18 mEq/d.
Ursodeoxy cholic acid
The changes in the organism of an individual losing weight by means of a low- energy-diet may lead to side effects such as gall stones. In a preferred embodiment
the diet further comprises ursodeoxy cholic acid to reduce the risk of gall stones. In another embodiment ursodeoxy cholic acid is administered separately as a tablet. In any event the ursodeoxy cholic acid is preferably administered in an amount of from 1000 mg/d to 1400 mg/d, preferably about 1200 mg/d.
Vitamins and minerals
Vitamins and minerals not mentioned above are dosed within the limits laid down by the health authorities, and may be included in the low-energy-diet or administered daily in tablet form. In particular vitamins and minerals are dosed according to Dietary Reference Intakes, Institute of medicine, USA, with modifications according to special requirements for overweight subjects on a low-calorie diet.
In a preferred embodiment the low-energy-diet according to the invention comprises per day
Carbohydrate: 70-120 g, including dihydroxy acetone phosphate 10-15g and/or pyruvate 10-20 g Protein: 50-80 g Fat: 5-20 g, including at least 3 g medium chain triglyeerides
Iron: 20-30 mg/d
In another embodiment the low-energy-diet according to the invention comprises per day
Carbohydrate: 70-120 g,
Protein: 50-80 g
Fat: 5-20 g, including at least 4 g medium chain triglyeerides
Iron: 20-30 mg/d
In a more preferred embodiment, the low-energy-diet according to the invention comprises per day
Carbohydrate: 70-120 g, including dihydroxy acetone phosphate 10-15g and/or py- ruvate 10-20 g
Protein: 50-80 g
Fat: 5-20 g, including at least 3 g medium chain triglyeerides Iron: 20-30 mg/d Magnesium: 15-20 mEq/d
In an even more preferred embodiment the low-energy-diet according to the invention comprises per day:
Carbohydrate: 70-120 g, including dihydroxy acetone phosphate 10-15g and/or py- ruvate 10-20 g
Protein: 50-80 g
Fat: 5-20 g, including at least 3 g medium chain triglyeerides
Iron: 20-30 mg/d
Magnesium: 15-20 mEq/d Fibres: 10-50 g/d
Formulation
The low-energy-diet according to the present invention may be formulated into any suitable form, such as powders, or ready-to-drink or ready-to-eat products. Thereby the individuals desiring to lose weight may adapt more to the diet, since they have a choice between various products.
In one embodiment the low-energy-diet is in the form of powder. Said powder may be dispensed in separate doses and suspended or solved in liquid, such as liquid selected from water and milk immediately before intake.
In another embodiment the low-energy-diet is formulated as a ready-to-drink product
In yet another embodiment the low-energy-diet is formulated as a bar
Applications
The low-energy-diet according to the invention is in particular meant for use in the treatment of overweight. Accordingly, the present invention further relates to a
method for treating overweight comprising administering to an individual in need thereof an effective amount of a low-energy-diet as defined above as the main or sole nutrition daily.
The diet is preferably divided into two or more portions per day to be administered at regular times for, for example to simulate the traditional meal times.
Another aspect of the invention relates to the use of ingredients being sources of
protein, carbohydrate, fat, and optionally minerals and pH-regulating agents, wherein one or more of the ingredient(s) has effect on at least two of the following mechanisms
the basal metabolic rate, and/or the protein metabolism, and /or the energy expenditure,
for the production of a low-energy-diet for administration as the main or sole nutrition.
The ingredients mentioned may be as described above.
The diet is preferably packed in a package intended for being able to cover the total nourishment requirement for a defined period of time, such as packages for a pow- der, a ready-to-drink product or a bar product.
Examples
Example 1
Powder formulation
A daily dose of the low-energy-diet
Carbohydrate: 96 g, including pyruvate 10 g
Protein (soy and casein): 70 g Fat (oleic acid): 15 g Fibres (barley): 15 g/d
Vitamins and minerals according to Nordis Alimantaris Plus extra addition of iron: 16 g
Flavours: 3 g
Example 2
Ready-to-drink formulation with vanilla flavour
Formula %
Water 74.8 Corn Syrup Solids, 24 8.2
Carbohydrate including pyruvate (10% of total) 6.8
Protein (casein and soy 50/50) 7.22
Oil (oleic acid) 1.146
Lecithin 0.4 Dicalcium phosphate 0.3
Avicel, FMC CL611 0.241
Vanilla flavours 0.460
Ca citrate 0.134
Mono potassium phosphate 0.096 Butterscotch 0.05
WSV premix 0.048
Viscarin 0.02
OSV premix 0.019
100.0 Example 3
Readv-to-eat product - bar with vanilla flavour
Formula
Water 82.2
Carbohydrate including pyruvate (10% of total) 8.49
Protein (casein and soy 50/50) 8.33
Avicel, FMC CL61 1 0.46
Vanilla Flavours 0.4
Butterscotch 0.08
Viscarin 0.04
Example 4
Production of powder formulation
A powder formulation consisting of the ingredients of table 1 were produced by mixing the ingredients and homogenising the powder.
Table 1
Example 5
Weight loss with a powder formulation
41 subjects were allocated to weight reduction intervention with a powder formulation as described in Example 4, and allocated to either low or high physical activity during the intervention, the subjects were as described in Table 2.
Table 2. Anthropometry for all 41 subjects entering weight reduction intervention with the formulation as described in Example 4
A (n=19) B (n=22) *P-value
Age (years) 42.4 ± 6.03 44.0 ± 8.4 0.475 (32 - 54) (28 - 59)
Height (m) 1.67 ± 0.06 1.65 ± 0.07 0.488 (1.57 - 1.78) (1 .51 - 1.77)
Weight (kg) 90.94 ± 8.57 90.55 ± 11.53 0.903 (77.00 - 109.00) (64.00 - 106.00)
Fat free mass (kg) 51.7 ± 3.2 51.7 ± 5.8 0.996 (46.2 - 61.0) (37.8 - 63.6)
Fat mass (kg) 39.2 ± 6.6 38.9 ± 6.7 0.853 (28.6 - 48.6) (26.2 - 48.8)
Pet Fat (%Body weight) 43 ± 4 42 ± 3 0.876
(36 - 48) (35 - 48)
Body mass index (kg/m2) 32.8 ± 3.7 33.0 ± 3.3 0.817
(27.0 - 40.0) (28.0 - 38.0)
Values are mean ± SD (min - max)
A: Subjects high in physical activity B: Subjects low in physical activity *: Analyzed using One-way ANOVA
The intervention lasted for 7 weeks, and the changes due to intervention after 7 weeks, using the formulation as described in Example 4 as the only nutrient is listed in Table 3.
Table 3.
A (n=19) B (n=22) *P-value
Weight (kg) -6.75 (-7.89 - -5.61 )a -6.73 (-7.82 - -5.64)a 0.984
Fat free mass (kg)
-1.6 (-2.5 - -0.7)b -2.4 (-2.89 - -1.86)a 0.125
Fat mass (kg)
-5.1 (-6.3 - -4.0)a -4.4 (-5.2 - -3.5)a 0.244
Pet Fat (%Body weight)
-3 (-4 - -2)a -2 (-2 - -1 )a 0.665
Body mass index (kg/m2) -2.7 (-3.7 - -1.6)a -2.3 (-2.7 - -1.9)a 0.134
Values are mean (95% confidence limits), a: analyzed using paired t-test (p<0.0001); b: analyzed using paired t-test (p=0.002). A: Subjects high in physical activity
B: Subjects low in physical activity
*: Analyzed using One-way ANOVA
The results of weight loss are shown graphically in Fig. 1 for both groups and the percentage weight loss is shown graphically in Fig. 2.
The results show that a weight loss generated by using the powder formulation of Example 4 is found in both groups of high physical activity as well as low physical activity.
Example 6
Weight loss in obese patients with knee osteoarthritis
Obese patients with knee OA are encouraged to reduce their body weight. Because of the musculoskeletal pain associated with physical activity among obese patients with knee OA, most of these patients lead a sedentary life with little exercise. A dietary approach to diminish the weight will be beneficial for the patients in several aspects including a reduced load on the weight bearing joints.
Speasy® from NutriCare A/S, having the formulation of Example 4 provided the subjects with 3.4 MJ/day (810 kcal): 37 E% from protein, 47 E% from carbohydrate and 16 E% from fat.
29 obese patients (Body mass index (BMI)>28 kg/m2) with knee OA who were randomized to either the LED (women/men: 13/1 ) or a conventional (C) hypocaloric diet (5 MJ/day) (women/men: 12/3). Their age was 65.1 ± 7.4 years (mean ± SD) and 65.7 ± 13.0 years, respectively, ranging from 45 to 90 years. The subjects' initial BMI was 36.3 ± 4.9 kg/m2 and 35.3 ± 3.7 kg/m2, and their lean body mass (LBM, assessed by electrical impedance) was 48.6 ± 7.5 kg and 52.4 ± 10.5 kg, respectively.
There was a significant weight reduction after both interventions. The LED intervention showed a reduction of 7.9 kg (95% confidence interval: 9.8 to 5.9;
P<0.0001 ), whereas the C produced only 2.7 kg (3.9 to 1.5; P<0.001) (treatment difference P<0.0001 ). In the LED, the LBM decreased by 3.2 kg (3.9 to 2.5;
P<0.0001 ) whereas the reduction was 1.9 kg (2.8 to 0.9; P<0.01 ) in C (treatment difference P<0.05). Thus, comparing the change in body composition (%LBM), we found a 1.1% (0.2 to 1.9; P<0.05) increase after LED, whereas no significant change after C: -0.4% (-1.3 to 0.4; P=0.27). 40.5 % of weight loss in the LED group consisted of LBM versus 70 % in the C group (P <0.02).
The LED showed a better weight reducing property, with a more favorable effect on body composition than a conventional hypocaloric diet after 8 weeks intervention. The results of this study demonstrate the possibility of reducing weight in elderly, sedentary patients, without loss of excessive lean body mass.
Claims
1. A low-energy-diet comprising as ingredients sources of
protein, carbohydrate, fat, and optionally minerals and pH-regulating agents, wherein one or more of the ingredient(s) has effect on at least two of the following mechanisms
the basal metabolic rate, and/or the protein metabolism, and /or the energy expenditure,
when the low-energy-diet is administered as the main or sole nutrition.
2. The low-energy-diet according to claim 1 , wherein the diet has an energy content in the range of from 600 kcal/d to 1200 kcal/d.
3. The low-energy-diet according to claim 2, wherein the diet has an energy content of approximately 800 kcal/d.
4. The low-energy-diet according to any of the preceding claims, wherein the source of protein is selected from casein, pork protein, and/or soy protein
5. The low-energy-diet according to claim 4, wherein at least a portion of the source of protein is soy protein.
6. The low-energy-diet according to any of the preceding claims, wherein the diet comprises the protein source in an amount of from 50 g protein to 80 g protein.
7. The low-energy-diet according to claim 6, wherein the diet comprises the protein source in an amount of from 60 g protein to 75 g protein.
8. The low-energy-diet according to any of the preceding claims, wherein the diet comprises the carbohydrate source in an amount of from 70 g carbohydrate to 120 g carbohydrate.
9. The low-energy-diet according to claim 8, wherein the diet comprises the carbohydrate source in an amount of from 80 g carbohydrate to 110 g carbohydrate.
10. The low-energy-diet according to any of the preceding claims, wherein at least a part of the carbohydrate source is selected from dihydroxy acetone phosphate and/or pyruvate.
11. The low-energy-diet according to claim 10, wherein the diet comprises dihydroxy acetone phosphate and/or pyruvate in an amount sufficient to increase the energy expenditure.
12. The low-energy-diet according to claim 10 or 11 , wherein the diet comprises dihydroxy acetone phosphate and/or pyruvate in an amount sufficient to in- crease satiety.
13. The low-energy-diet according to claim 10, 1 1 or 12, wherein the diet comprises dihydroxy acetone phosphate in an amount of from 5 g to 15 g.
1 . The low-energy-diet according to claim 10, 11 , 12 or 13, wherein the diet comprises pyruvate in an amount of from 5 g to 20 g.
15. The low-energy-diet according to claim 14, wherein the pyruvate is in the form of sodium pyruvate and/or calcium pyruvate.
16. The low-energy-diet according to any of the preceding claims, wherein the diet comprises the fat source in an amount of from 5 g to 20 g.
17. The low-energy-diet according to claim 16, wherein at least 3 g of the fat source is a fat source capable of increasing the energy expenditure.
18. The low-energy-diet according to claim 17, wherein at least 3 g of the fat source is medium chain triglyeerides.
19. The low-energy-diet according to claim 18, wherein the medium chain triglyeerides are selected from C6 triglyeerides, C8 triglyeerides and C10 triglyeerides.
20. The low-energy-diet according to any of the preceding claims, wherein at least 3 g of the fat source is fish oil.
21. The low-energy-diet according to any of the preceding claims, wherein the diet comprises pH-regulating agent in an amount sufficient to reduce protein degradation.
22. The low-energy-diet according to claim 21 , wherein the diet comprises as the pH-regulating agent bicarbonate in an amount sufficient to reduce protein degradation.
23. The low-energy-diet according to claim 21 , wherein the diet comprises bicarbonate in an amount of from 50 mmol/d to 70mmoι7d.
24. The low-energy-diet according to any of the preceding claims, wherein diet comprises iron in an amount sufficient to modulate the basal metabolic rate.
25. The low-energy-diet according to claim 24, wherein the diet comprises iron in an amount sufficient to prevent reduction in the basal metabolic rate.
26. The low-energy-diet according to claim 24 or 25, wherein the diet comprises iron in an amount of from 20 mg/d to 30 mg/d.
27. The low-energy-diet according to any of the preceding claims, wherein the diet further comprises dietary fibres.
28. The low-energy-diet according to claim 27, wherein the dietary fibres are selected from barley fibres, sugar beat fibres and oat fibres.
29. The low-energy-diet according to any of the preceding claims, wherein the diet further comprises magnesium.
30. The low-energy-diet according to claim 29, wherein the magnesium is added as MgCI.
31. The low-energy-diet according to any of the preceding claims, wherein the diet further comprises ursodeoxy cholic acid.
32. The low-energy-diet according to any of the preceding claims, wherein the diet is in the form of powder.
33. The low-energy-diet according to claim 32, wherein the powder is capable of being suspended or solved in liquid, such as liquid selected from water and milk.
34. The low-energy-diet according to any of the preceding claims 1 -31 , wherein the diet is in the form of ready-to-drink product.
35. The low-energy-diet according to any of the preceding claims 1-31 , wherein the diet is in the form of bar product.
36. The low-energy-diet according to any of the preceding claims, wherein the diet is suited for the main or sole nutrition daily, said diet being divided into two or more portions per day.
37. The low-energy-diet according to claim 36, wherein the diet is packed in a package intended for being able to cover the total nourishment requirement for a de- fined period of time.
38. A method for treating overweight comprising administering to an individual in need thereof an effective amount of a low-energy-diet as defined in any of the claims 1-36 as the main or sole nutrition daily.
39. Use of ingredients being sources of
protein, carbohydrate, fat, and optionally minerals and pH-regulating agents, wherein one or more of the ingredient(s) has effect on at least two of the follow- ing mechanisms
the basal metabolic rate, and/or the protein metabolism, and /or the energy expenditure,
for the production of a low-energy-diet for administration as the main or sole nutrition.
40. The use according to claim 39, wherein the ingredients are as defined in any of claims 1 -31.
41. The use according to claim 39 or 40, wherein the diet is in the form of a powder or a ready-to-drink product or a bar product.
Priority Applications (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP03732250A EP1534087A1 (en) | 2002-06-21 | 2003-06-23 | Low-energy-diet |
| AU2003239772A AU2003239772A1 (en) | 2002-06-21 | 2003-06-23 | Low-energy-diet |
| US10/518,993 US20050214347A1 (en) | 2002-06-21 | 2003-06-23 | Low-energy-diet |
Applications Claiming Priority (4)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| DKPA200200959 | 2002-06-21 | ||
| DKPA200200959 | 2002-06-21 | ||
| US40252902P | 2002-08-12 | 2002-08-12 | |
| US60/402,529 | 2002-08-12 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| WO2004000044A1 true WO2004000044A1 (en) | 2003-12-31 |
Family
ID=30001773
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PCT/DK2003/000424 WO2004000044A1 (en) | 2002-06-21 | 2003-06-23 | Low-energy-diet |
Country Status (3)
| Country | Link |
|---|---|
| EP (1) | EP1534087A1 (en) |
| AU (1) | AU2003239772A1 (en) |
| WO (1) | WO2004000044A1 (en) |
Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2351491A1 (en) * | 2008-11-06 | 2011-08-03 | The Nisshin OilliO Group, Ltd. | Concentrated liquid diet |
Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3976800A (en) * | 1973-07-12 | 1976-08-24 | Klosterfrau Berlin Gmbh | Process for the manufactue of biscuits |
| WO1980002226A1 (en) * | 1979-04-16 | 1980-10-30 | Elaine Powers Nutrition Co Inc | Meal replacement composition |
| EP0147699A2 (en) * | 1984-01-04 | 1985-07-10 | Societe Des Produits Nestle S.A. | Foodstuff for the treatment of leprosy |
| US4548937A (en) * | 1981-04-01 | 1985-10-22 | Montefiore Hospital | Method for preventing body fat deposition in mammals |
| EP0425423A2 (en) * | 1989-10-24 | 1991-05-02 | Hoeie, Lars Henrik | A process for the preparation of a low-calorie nutritional preparation |
-
2003
- 2003-06-23 EP EP03732250A patent/EP1534087A1/en not_active Withdrawn
- 2003-06-23 AU AU2003239772A patent/AU2003239772A1/en not_active Abandoned
- 2003-06-23 WO PCT/DK2003/000424 patent/WO2004000044A1/en not_active Application Discontinuation
Patent Citations (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3976800A (en) * | 1973-07-12 | 1976-08-24 | Klosterfrau Berlin Gmbh | Process for the manufactue of biscuits |
| WO1980002226A1 (en) * | 1979-04-16 | 1980-10-30 | Elaine Powers Nutrition Co Inc | Meal replacement composition |
| US4548937A (en) * | 1981-04-01 | 1985-10-22 | Montefiore Hospital | Method for preventing body fat deposition in mammals |
| EP0147699A2 (en) * | 1984-01-04 | 1985-07-10 | Societe Des Produits Nestle S.A. | Foodstuff for the treatment of leprosy |
| EP0425423A2 (en) * | 1989-10-24 | 1991-05-02 | Hoeie, Lars Henrik | A process for the preparation of a low-calorie nutritional preparation |
Cited By (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2351491A1 (en) * | 2008-11-06 | 2011-08-03 | The Nisshin OilliO Group, Ltd. | Concentrated liquid diet |
| EP2351491A4 (en) * | 2008-11-06 | 2014-03-12 | Nisshin Oillio Group Ltd | Concentrated liquid diet |
| US9907774B2 (en) | 2008-11-06 | 2018-03-06 | The Nisshin Oillio Group, Ltd. | Concentrated liquid diet |
| US10285965B2 (en) | 2008-11-06 | 2019-05-14 | The Nisshin Oillio Group, Ltd. | Method for supplementing and administering a concentrated liquid diet |
| US10383838B2 (en) | 2008-11-06 | 2019-08-20 | The Nisshin Oillio Group, Ltd. | Concentrated liquid diet |
Also Published As
| Publication number | Publication date |
|---|---|
| AU2003239772A1 (en) | 2004-01-06 |
| EP1534087A1 (en) | 2005-06-01 |
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