CN106604651A - Nutritional composition for treating or preventing pregnancy-related disorders - Google Patents

Nutritional composition for treating or preventing pregnancy-related disorders Download PDF

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CN106604651A
CN106604651A CN201580047521.5A CN201580047521A CN106604651A CN 106604651 A CN106604651 A CN 106604651A CN 201580047521 A CN201580047521 A CN 201580047521A CN 106604651 A CN106604651 A CN 106604651A
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weight
compositionss
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C·L·加尔奇亚-罗德纳斯
I·席尔瓦佐雷兹
K-A·勒
T·J·伍斯特
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Societe des Produits Nestle SA
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    • 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
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/115—Fatty acids or derivatives thereof; Fats or oils
    • 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
    • A23L33/40—Complete food formulations for specific consumer groups or specific purposes, e.g. infant formula
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/10—Laxatives
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23V—INDEXING SCHEME RELATING TO FOODS, FOODSTUFFS OR NON-ALCOHOLIC BEVERAGES AND LACTIC OR PROPIONIC ACID BACTERIA USED IN FOODSTUFFS OR FOOD PREPARATION
    • A23V2002/00—Food compositions, function of food ingredients or processes for food or foodstuffs

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Abstract

The present invention provides a maternal composition comprising more than 50 wt.% long chain fatty acids and 50 wt.% or less medium chain fatty acids, relative to the total fatty acid concentration, for use in the treatment or prevention of acid reflux, nausea or vomiting, gestational diabetes mellitus and/or a condition associated with any of the foregoing in a pregnant mammal and/or its offspring, wherein the maternal composition is administered to the mammal before and/or during pregnancy and/or during lactation.

Description

For treating or preventing the alimentation composition of pregnant associated conditions
Technical field
The present invention relates to parent compositionss, which includes the long-chain for total fatty acids concentration more than 50 weight % Fatty acid and 50 weight % or less medium-chain fatty acid, for the treatment in pregnant mammal and/or its offspring or pre- Anti- regurgitation of gastric juice, n or V, gestational diabetes and/or the disease related to aforementioned any one.
Background technology
Nausea and vomiting, regurgitation of gastric juice and dyspepsia are all the common disorder of gastrointestinal tract for affecting pregnant mammal.These The scope that the seriousness of disease is related to can feel under the weather from slightly benign, to it is serious, and jeopardize in rare cases Life.Depending on the order of severity, aforementioned disorders may not only threaten the health and happiness of pregnant mammal, in some instances it may even be possible to which The healthy development of offspring threatens.
In period of gestation, there occurs is considered as various physiological changies of the pathophysiological process for facilitating aforementioned disorders.However, It is believed that causing the various change of gastric motility disorders (more specifically gastric emptying rate slows down) outstanding with the relation of these diseases Its closely (Prolonged gastric emptying rates increase the risk of GER (Omür O, M, H, C,Mol Imaging Radionucl Ther.2014), (" gastric emptying rate Slow down increase GER risks "Omür O、 M、 H、 C,《Molecular imaging is controlled with radionuclide Treat》, 2014)；nausea and vomiting(Stein B 1 ,Everhart KK,Lacy BE.Curr Treat Options Gastroenterol.2014), " nausea and vomiting " (Stein B 1 、Everhart KK、Lacy BE,《Gastroenterology Newest Therapeutic Method》, 2014)).Fast evacuation gastric content can prevent or alleviate regurgitation of gastric juice and nausea/vomiting after the meal. Therefore, gastric motility can be improved, the combination object depth of gastric emptying rate is especially to speed up by the industry for being devoted to mother's health care Concern.
There are various pharmaceutical compositions accelerate gastric emptying rate, so as to can be used to treat or preventing aforementioned disorders.But, Due to worrying to affect the health of offspring, mother and its doctor generally to oppose to use pharmacotherapy in period of gestation.
Accordingly, it would be desirable to gastric emptying rate can be accelerated, thus can be used to treating and/or prevent the nausea and vomiting of pregnant individuals, Regurgitation of gastric juice and dyspeptic non-drug compositionss.
Inventor it has been found that comprising relative to total fatty acids concentration more than 50 weight % long-chain fatty acid and 50 weights The parent of amount % or less medium-chain fatty acid compositionss are emptied from stomach rapidly, thus can be used to accelerate gastric emptying.This Now especially with the medium-chain fatty acid for comprising more than 50 weight % and the compositionss of 50 weight % or less long-chain fatty acid Obtained from comparing.The discovery is wondrous, and reason is that prior art teaches that, long-chain fatty acid slows down gastric emptying, and Medium-chain fatty acid does not affect (Kossena GA, Charman WN, Wilson CG, O'Mahony B, Lindsay to gastric emptying B,Hempenstall JM,Davison CL,Crowley PJ,Porter C.J.Pharm Res.2007Nov；24(11): 2084-96(Kossena GA、Charman WN、Wilson CG、O'Mahony B、Lindsay B、Hempenstall JM、 Davison CL, Crowley PJ, Porter C.,《Drug research magazine》, in November, 2007, the o. 11th of volume 24, the 2084-2096 page)).Inventor also has found that compositionss of the invention increased individual fibroblast growth factor in vivo The expression of 19 (hereinafter referred to as FGF19).
The content of the invention
The content of the invention is stated in detail in the claims.Comprising relative to total fatty acids concentration more than 50 weight % long-chain fat The parent of fat acid and 50 weight % or less medium-chain fatty acid compositionss are emptied from stomach rapidly, can be used to accelerate stomach row Expression that is empty and increasing individual FGF19 in vivo, therefore can be used to treat and/or prevent pregnant individuals (for example, pregnant cat, Canis familiaris L. Or people) n or V, regurgitation of gastric juice, dyspepsia and gestational diabetes.
Parent comprising relative to total fatty acids concentration less than the medium-chain fatty acid of 5 weight % of the invention is combined Thing may be especially effective.Parent compositionss of the invention may be comprising selected from following long-chain fatty acid：Myristic acid, Palmic acid, palmitoleic acid, stearic acid, Oleic acid, linoleic acid, α-linoleic acid, arachidic acid, eicosenoic acid, and these materials Combination.
Due to fatty acid be triglyceride form when its absorb increase, it is thus possible to preferably, the present invention parent use Each type of long-chain and/or medium-chain fatty acid included in compositionss main (for example, at least 98%, 99% or 99.5%) For triglyceride form.
Palmic acid (the especially Palmic acids of sn 1 or 3 triglyceride forms) has been notified and causes and/or increase constipation.Cause This, the present invention with low palmitic acid concentration (wherein, the Palmic acid especially sn less than 14%, more specifically less than 7% The Palmic acid of 1 or 3 triglyceride forms) parent compositionss, or without Palmic acid (especially sn 1 or 3 triglyceride The Palmic acid of form) parent compositionss can also be used for treatment or Constipation.
If parent compositionss of the invention and the nausea for being known to be used in treating or preventing pregnant individuals are vomitted Tell, regurgitation of gastric juice, dyspepsia, the composition (for example, vitamin B6, Rhizoma Zingiberis Recens or its extract) of gestational diabetes and/or constipation With reference to or be applied in combination, then can particularly effectively treat or prevent these diseases of pregnant individuals.
Parent compositionss of the invention before pregnancy and/or enteral during period of gestation and/or suckling can be applied For pregnant individuals, can apply in any time at daytime or night, also can front administration on the feed.
Parent compositionss of the invention can be by the form of fat blends (for example, packaged fat blends) Apply, or alternatively, can be by the powdered nutritional compositions, food product, drink that will be reconstructed in such as breast, fruit juice or water The Powdered nutritional being sprayed onto on food or be mixed in aqueous medium such as breast, fruit juice or water (is such as mended by material, supplementary Fill agent) or nutrient and healthcare products form apply.
It is as described herein, n or V, regurgitation of gastric juice, dyspepsia and gestational diabetes with affect pregnant individuals And/or the various disease conditions of its offspring are related, these diseases are for example：It is dehydration, electrolyte imbalance, malnutrition, small for gestational age infant, quiet Arteries and veins thromboembolism, pulmonary infarction, preeclampsia and macrosomia, the maternal infuries caused by mother or baby, shoulder dystocia, premature labor and Cesarean esction It is that (hereinafter referred to as cesarean), mother occur after pregnancy immediately and go out at the type ii diabetes, baby for occurring in the future Existing glucose tolerance reduces and/or suffers from metabolic disease (for example, type ii diabetes and the obesity of overweight/obesity and correlation Disease), and offspring is at the depression, bipolar disorder and anxiety neurosis for occurring in the future.Therefore, by treating or preventing described The n or V of pregnant individuals, regurgitation of gastric juice, dyspepsia, constipation and gestational diabetes, the compositionss of the present invention may be used also For treating or preventing the aforementioned associated conditions of the pregnant individuals or its offspring.
Description of the drawings
Fig. 1 shows the overview studied described in embodiment 1.
Fig. 2 shows the result of gastric emptying measurement.M=meals (its composition referring to table 1, and table 2 to table 6)；* represent P< 0.0001；* represents P=0.0003.Half-time emptying (t50/min)
Fig. 3 shows the measurement result of FGF19 in the blood sample gathered during the experiment described by embodiment 1.M= Meals (its composition referring to table 1, and table 2 to table 6)；* represents P=0.001.Area (AOB) on baseline, (pg/mL min).
Fig. 4 shows the measurement result of bile acid in the blood sample gathered during the experiment described by embodiment 1.Base Area (AOB) on line, (μm ol/L min).* represent P=0.9；* represents P=0.3；* * represent P=0.0003；* * * are represented P=0.0001.
The present invention will be described in further detail now.
Specific embodiment
As described above, inventor it has been found that comprising the long-chain fatty acid relative to total fatty acids concentration more than 50% with And 50% or less medium-chain fatty acid parent with compositionss rapidly from stomach empty, thus can be used for accelerate gastric emptying speed Rate.
It is considered as to facilitate the various disease conditions for affecting pregnant individuals as gastric motility declines (especially gastric emptying prolongation) One factor of (that is, regurgitation of gastric juice, n or V, and dyspepsia)；So, rapidly from stomach emptying, thus can pierce Swash and/or accelerate the compositionss of gastric emptying to can be used for one or more for treating or preventing in above-mentioned these diseases, and with bosom Disease pregnant individual and/or that its offspring is related.
Think that a kind of condition of compositionss rapidly from stomach emptying is the half of the compositionss being consumed at 350 to 550 points In clock, specifically in being drained in 400 to 500 minutes.
The half of compositionss is referred to as T50mea from the time that stomach is emptied.
The gastric emptying time of compositionss can adopt method measurement known to technical staff.A kind of such method is this paper's Illustrate in embodiment 1.
Another advantage of parent compositionss of the invention is, it was found that they increase the secretion of bile acids and The expression of FGF19.
FGF19 is a kind of intestinal hormoness, by strengthening insulin sensitivity and can induce Glycogen synthesis, and to glucose metabolism Produce beneficial effect.It has been found that suffering from the FGF19 in the pregnant individuals body of gestational diabetes (hereinafter referred to as GDM) Cyclical level is reduced, and insulin resistance negative correlation (Wang, 2013) with the colony.And it was demonstrated that improve FGF19 Cyclical level be to prevent and treat that insulin resistant is bad and the useful means (Shaap et al., 2012) of type 2 diabetes mellitus. Therefore, the compositionss for improving FGF19 cyclical levels can be used to treating or prevent GDM, or pregnant individuals and/or its offspring with GDM related disease.
Therefore, in a first aspect of the present invention, there is provided a kind of parent compositionss, which includes dense relative to total fatty acids It is 50 weight % or more long-chain fatty acid and the medium-chain fatty acid less than 50 weight % for degree, in pregnant suckling Treat in animal and/or its offspring or prevention regurgitation of gastric juice, n or V, dyspepsia and/or gestational diabetes, and/ Or the disease related to aforementioned any one.
" individuality " refers to mammal, more specifically cat, Canis familiaris L. or people as the term is employed herein.
" treat " as the term is employed herein and be also contemplated by improving and/or mitigating disease, the symptom of such as disease.
" nausea and vomiting " refers to the nausea and vomiting of any degree of trimester of pregnancy experience as the term is employed herein.Which includes pregnant Be pregnent hypermesis (HG).HG is the nausea and vomiting form of trimester of pregnancy most serious, affects 0.5% to 2% anemia of pregnant woman.HG can be defined as Serious and lasting nausea and vomiting, its can cause the body weight for mitigating exceed pregestational weight 5%, dehydration, electrolyte imbalance and battalion Support and lack, it usually needs hospitalization.
Depending on the order of severity, n or V is likely to result in parent weightening in the whole pregnancy period and reduces, and this may cause tire Youngster's development is undesirable.In addition, the risk of the women of the deep hardship by extreme nausea and vomiting (such as HG), its small for gestational age infant and premature labor May be higher.It is also known that n or V (especially HG) is the risk of venous thromboembolism, pulmonary infarction and preeclampsia Factor.Additionally, n or V (especially HG) during pregnancy, suffers from depression, bipolar disorder in the manhood with offspring Raise with the risk of anxiety neurosis associated.
" GDM " refers to that the glucose of any degree for occurring or finding first in period of gestation is resistance to as the term is employed herein By bad.
Mammal with the presence or absence of glucose tolerance reduce, can by measure its fasting plasma glucose concentration or pass through into Row oral glucose tolerance test (OGTT) is determining.Technical staff is familiar with these tests, and for diagnosing glucose tolerance Reduce, thus diagnosis GDM multiple standards.According to the national clinical biochemistry published by U.S. clinical chemistry association (AACC) Listed standard in institute (NACB) guide, if the fasting plasma glucose concentration of the human individual of pregnancy is equal to 5.1mmol/L or higher, or the individuality drinking 75 grams of glucoses, 1 hour blood sugar concentration afterwards equivalent to being less than 10mmol/L is drinking 75 grams of glucoses, 2 hours blood sugar concentrations afterwards equivalent to less than 8.5mmol/L, then it is assumed that this The glucose tolerance of body is reduced.
GDM may increase the onset risk of various female fetal diseases diseases, including macrosomia, the maternal infuries caused by mother or baby, Shoulder dystocia, premature labor and Cesarean esction (hereinafter referred to as cesarean).In addition, suffering from mother of GDM after pregnancy and in the future The risk of the type ii diabetes of appearance is raised；And, the depression of offspring's appearance of the mother for suffering from GDM, Bipolar barrier Glucose tolerance is hindered to reduce and/or suffer from metabolic disease (for example, type ii diabetes and the fertilizer in the future of overweight/obesity and correlation Fat disease) risk raise.
As the term is employed herein " regurgitation of gastric juice " refer to that acid ascends into the disease of esophagus, also referred to as stomach oesophagus from stomach Reflux (GER), is referred to as gastro-oesophageal reflux disease (GERD) when serious.
" dyspepsia " refers to the disease that the digestion power of individuality weakens as the term is employed herein.This is a kind of medical science disease Disease, it is characterized by the epigastrium chronic or recurrent pain of generation, epigastrium are glutted, and occurs satisfying than expected when on the feed earlier Abdomen sense.Dyspepsia can be with abdominal distention, belch, nausea.
" medium-chain fatty acid " is referred to the saturated fat straight chain comprising 6 to 12 carbon atoms as the term is employed herein N- carboxylic acids and its derivant.Any of specific medium-chain fatty acid is referred to, also includes that any one derivant is referred to which.
As the term is employed herein " long-chain fatty acid " refer to by 13 or more (more specifically 13 to 22 It is individual) carbon atom composition saturated fat straight chain n- carboxylic acids and its derivant.Any of specific long-chain fatty acid is referred to, is also wrapped Include any one derivant to which to refer to.
The non-limiting example of the derivant of medium-chain fatty acid and/or long-chain fatty acid includes phospholipid, triglyceride, glycerol Diester and monoglyceride.
The present invention parent compositionss can comprising relative to total fatty acid content be 50 to 100 weight % (for example, 50 to 60 weight %, 50 to 70 weight %, 60 to 80 weight %, 60 to 90 weight %, 95 to 100 weight %) in the range of it is any dense The long-chain fatty acid of degree.
The present invention parent compositionss can comprising relative to total fatty acids be less than 50 weight % (for example, 0 to In the range of 49.99 weight %, 10 to 40 weight %, 5 to 30 weight %, 12 to 45 weight %) any concentration Medium chain fatty Acid.
In one embodiment, compositionss of the invention are free or substantially free of medium-chain fatty acid.It is so-called " substantially Without ", mean that the compositionss contain up to 5%, 2% or 1% medium-chain fatty acid.
Any one long-chain fatty acid of suitable pregnant individuals intake is utilized within the compositionss of the present invention.
The non-limiting example of suitable long-chain fatty acid includes：Myristic acid, Palmic acid, palmitoleic acid, stearic acid, oil Acid, linoleic acid, α-linoleic acid, arachidic acid, eicosenoic acid, and the combination of these materials.
Any one medium-chain fatty acid of suitable pregnant individuals intake is utilized within the compositionss of the present invention.
The non-limiting example of suitable medium-chain fatty acid includes：Caproic acid, octanoic acid, capric acid, dodecylic acid, and these things The combination of matter.
In one embodiment of the invention, the long-chain fatty acid being included in the parent compositionss of the present invention And/or medium-chain fatty acid is mainly triglyceride form.
So-called " main ", means at least 98 weight %, more specifically at least 99.5 weight %, or even more specifically More than 99.5 weight %.
The long-chain fatty acid and medium-chain fatty acid being included in the parent compositionss of the present invention can be saturation, insatiable hunger It is sum or polyunsaturated.
The example of unsaturated fatty acid includes Oleic acid, and polyunsaturated fatty acid (PUFA), such as linoleic acid, α-Asia oil Acid, arachidonic acid, docosahexenoic acid and/or eicosenoic acid.
The example of polyunsaturated fatty acid includes alpha-linolenic acid (ALA) 18:3rd, parinaric acid (SDA) 18:4th, 20 Carbon trienic acid (ETE) 20:3rd, n-3 eicosatetraenoic acid (ETA) 20:4th, eicosapentaenoic acid (EPA) 20:5th, 22 carbon of n-3 Five olefin(e) acid (DPA) 22:5th, docosahexenoic acid (DHA) 22:6th, linoleic acid 18:2nd, gamma-Linolenic acid (GLA) 18:3rd, n-6 20 Carbon dienoic acid 20:2nd, dihomo-gamma-linolenic acid (DGLA) 20:3rd, arachidonic acid (AA or ARA) 20:4th, 22 carbon diene of n-6 Acid 22:2, and clupanodonic acid 22:5.
In a specific embodiment, compositionss of the invention are mainly triglyceride form not comprising at least one Satisfied fatty acid, relative to total fatty acids concentration, in an amount of from least 15 weight %, at least 20 weight %, at least 35 weight %, extremely Few 38 weight %, 40 weight % to 90 weight %, 50 weight % to 80 weight %, 50 weight % to 75 weight %, 50 weight % To 70 weight %, 55 weight % to 70 weight %.
In another embodiment of the present invention, parent of the invention compositionss are comprising at least one how unsaturated fat Fat acid (PUFA), the PUFA are present with the amount that 8 weight % or 10 weight % are generally at least relative to total fatty acids concentration.
There is PUFA to be particularly conducive to provide several crucial health benefits, such as cognitive benefit, vision and cognitive development, Antiinflammatory property, this is known in the art.
If the parent of present invention compositionss, may particularly advantageous, these PUFA bags comprising following PUFA is selected from Include：For the alpha-linolenic acid and/or linoleic acid of essential fatty acid, and/or it is known to such as cognitive competence unsoundness benefit 20 Two carbon acid (DHA, C22:And/or arachidonic acid (ARA, C20 6):4).
Essential fatty acid refers to that the good health status of body holding are essential, but body itself can not synthesize again, because And the fatty acid that must be taken in.
In a specific embodiment, parent of the invention includes linoleic acid and/or α-linoleic acid with compositionss, especially It is conceived to its total combined concentration, relative to total fatty acids concentration in 10 to 15 weight %, 12 to 14 weight %, 12.5 to 13.9 weights In the range of amount %.
In another embodiment of the present invention, parent of the invention includes Palmic acid (more specifically with compositionss The Palmic acid of sn 1 or 3 triglyceride forms), relative to total fatty acid content, its amount is being less than 14 weight %, more specifically In the range of 7 weight %, 6 weight %, 5 weight %, 4 weight %, 3 weight %, 2 weight %.
Palmic acid (the especially Palmic acids of sn 1 or 3 triglyceride forms) is released as free fatty in digestion process Put, and the soaps containing indigested calcium can be formed.These materials cause stool hardness to increase in discharge process.Therefore, The amount of Palmic acid (the especially Palmic acids of sn 1 or 3 triglyceride forms) is reduced, prevention or constipation relieving is can help to.
11% to 38% anemia of pregnant woman suffers from constipation.Constipation is described as stool and reduces or difficult defecation.
In another embodiment of the present invention, without Palmic acid, (especially sn 1 or 3 is sweet with compositionss for the parent The Palmic acid of oily three ester-formins).
In the other embodiments of the present invention, under the parent compositionss are comprising relative to total fatty acid content being The following medium-chain fatty acid of row percentage by weight and/or long-chain fatty acid：
Concentration 0 to 1 weight % such as 0.05 to 0.5 weight %, 0.05 to 0.4 weight %, 0.06 to 0.4 weight %, Or 0.07 to 0.3 caproic acid in the range of weight %；And/or
Concentration is in 0 to 10 weight % such as 2 to 8 weight %, 1.55 to 2 weight %, 1.6 to 2 weight %, 1.65 to 2 weights Octanoic acid in the range of amount %, 1.7 to 2 weight %；And/or
Concentration 0 to 10 weight % such as 0 to 1.8 weight %, 0.1 to 1.8 weight %, 1 to 1.7 weight %, 1 to 1.5 Capric acid in the range of weight % or 1.2 to 1.8 weight %；And/or
Concentration 0 to 12.0 weight % such as 0 to 10 weight %, 0 to 8 weight %, 0 to 6 weight %, 0 to 4 weight %, 1 To 12 weight %, 2 to 12 weight %, 4 to 12 weight %, 6 to 12 weight %, 8 to 12 weight %, 10 to 12 weight % Dodecylic acid；
Concentration 0 to weight % such as 0.05 to 0.5 weight %, 0.05 to 0.4 weight %, 0.06 to 0.4 weight % or Myristic acid in the range of 0.07 to 0.3 weight %；And/or
Palm fibre of the concentration in the range of 0 to 5 weight % such as 2 to 4 weight %, 2 to 3.5 weight %, 2.3 to 3.4 weight % Palmitic acid acid, and/or
Concentration is in 0 to 1 weight % such as 0.05 to 2 weight %, 0.05 to 1.5 weight %, 0.05 to 0.12 weight % model Palmitoleic acid in enclosing；And/or
Concentration is in the range of 0 to 3 weight % such as 1 to 3 weight %, 1 to 2.5 weight %, 2.51 to 1.04 weight % Stearic acid；And/or
Oil of the concentration in the range of 0 to 70 weight % such as 10 to 70 weight %, 10 to 60 weight %, 10 to 50 weight % Acid；And/or
Linoleic acid of the concentration in the range of 9 to 11 weight %, 10 to 10.5 weight %；And/or
α-linoleic acid of the concentration in the range of 2 to 5 weight %, 2 to 3.5 weight %, 2.2 to 3.2 weight %；And/or
Arachidic acid of the concentration in the range of 0.1 to 0.5 weight %, 0.1 to 0.5 weight %, 0.2 to 0.31 weight %；With/ Or
Eicosenoic acid of the concentration in the range of 0.5 to 1 weight %, 0.5 to 0.6 weight %, 0.51 to 0.57 weight %； And/or the combination in any of these materials.
The parent compositionss of the present invention can provide with regard to treat or prevent GDM and with pregnant individuals and/or thereafter Use for any effective dose of the benefit of GDM related disease.
Effective dose can be improve in any degree the regurgitation of gastric juice of pregnant individuals, n or V, dyspepsia, Constipation and/or any dosage of gestational diabetes (i.e. glucose tolerance reduction).
Determine effective dose completely in the limit of power of those skilled in the art.Generally, effective dose will be depending on individual The type of body, age, build and health status, depending on individual life style and its gene genetic.
Useful especially dosage can be comparable in parent compositionss comprising 100mg to 500mg, 200 to 350mg or The dosage of the total fatty acids of 200mg to 300mg.
" dosage " refers to before pregnancy (that is, standby pregnant is individual) and/or (that is, cherishes in period of gestation as the term is employed herein Pregnant individuality) and/or be applied to during suckling individuality parent compositionss daily amount.
Daily amount or dosage can one-time use, or can divide in one day and apply several times.Dosage can be by any known Method apply, especially enteral (as oral) applies.
Dosage can be applied in any time at daytime or night.However, according to disease to be treated, applying in special time Dosage is probably beneficial.For example, for nausea and/vomiting, any time application dosage in the morning or before feed on daytime It is possibly beneficial；For regurgitation of gastric juice and dyspepsia, front or before feed on daytime any time applied agents are slept at night Amount is probably beneficial；For GDM, before feed on daytime, application dosage is probably beneficial.
If front administration compositionss on the feed, then can on the feed first 2 hours, 1 hour, 30 minutes, 20 minutes, 10 minutes Or apply for 5 minutes.
If it is individual that the parent compositionss of the present invention are applied to standby pregnant, then can be for example before pregnancy or standby pregnant at least Apply in 1 month, 2 months, 3 months or 4 months.If being applied to pregnant individuals, then can apply within the pregnancy period all or in part With at least 4 weeks, at least 8 weeks, at least 12 weeks, at least 16 weeks, at least 20 weeks, at least 24 weeks, at least 28 weeks or at least 36 weeks, specifically Depending on individual trimester of pregnancy.If applied in age of sucking, then can apply in the individual age of sucking all or in part.
Due to n or V it is more universal in early pregnancy and mid-term, therefore early pregnancy and/or mid-term apply with Treat and/or prevent this disease to be probably particularly advantageous.
As regurgitation of gastric juice and dyspepsia are more universal in mid pregnancy and late period, therefore apply in mid pregnancy and late period It is probably particularly advantageous to treat and/or prevent one or more these disease.
As GDM increases in mid pregnancy and late period risk, therefore apply to treat and/or in advance in mid pregnancy and late period Prevent that this disease is probably particularly advantageous.
The parent compositionss of the present invention can be the fat blends being only made up of fat.Or, parent compositionss The other compositions commonly used during parent compositionss can be included, such as said composition can also be comprising protein sources (such as milk powder or defat Milk powder) and carbohydrate source (such as sucrose and/or maltodextrin), it is also possible to comprising lecithin, soybean lecithin and/or increasing Amount agent.The compositionss of the present invention can also include probiotic bacteria, prebioticses, vitamin and mineral.For example, government organs are (such as USRDA the vitamin and mineral for) being proposed to be used in pregnancy period supplement is such as calcium, magnesium, phosphorus, ferrum, zinc, copper, iodine, selenium, vitamin A or Retinol active equivalents (RAE) (as beta-carotene or carotenoid, vitamin C, vitamin B1, nicotinic acid, Folic Acid, biotin, The mixture of Vitamin E).The non-limiting example of other possible compositions includes：Other nutrient substance, are selected from lipid (such as Short-chain fatty acid), carbohydrate and protein, micronutrient (in addition to those described above) or pharmaceutically active agents；It is conventional Food additive, such as antioxidant, stabilizer, emulsifying agent, acidulant, thickening agent, buffer agent or pH regulator reagent, chelating Agent, coloring agent, excipient, flavoring agent, penetrating agent, pharmaceutically acceptable carrier, preservative, sugar, sweeting agent, quality structure agent, water And any combination of them.
Alternatively or in addition, the parent compositionss can also contain glucose syrup, butterfat, citric acid Magnesium, choline salt and cholinester, prebiotic fiber and/or ascorbyl palmitate.For example, local flavor compounds (example can be added Such as, cocoa powder or Mel) providing different taste.
If the parent compositionss comprising be known to be used in treat n or V, regurgitation of gastric juice, dyspepsia and/or The other compositions (for example, as it is known that vitamin B6, Rhizoma Zingiberis Recens or its extract can be used to treat or prevent nausea and vomiting) of GDM, then Such case is probably particularly advantageous.
The parent compositionss of the present invention may be adapted to any form of individual intake and apply, and for example, which can be powder Shape alimentation composition, food product, beverage, nutriment, supplementary (for example, will be sprayed onto on food or be mixed into medium (such as Water, fruit juice or breast) in powdered nutritional supplement).
The non-limiting example of food product is included based on the product of frumentum, Yoghourt or other milk product and rod.
Supplementary can be provided for example in the form of pill, tablet or replenisher powder, and these dosage forms for example can be mixed into In medium (Ru Shui, breast or fruit juice) or it is sprayed on food.
The powdered nutritional supplement that can be for example sprayed on food or be mixed in medium (such as water, fruit juice or breast) is current Accepted extensively by consumer.
As described above, nausea and vomiting and/or regurgitation of gastric juice and/or dyspepsia and/or GDM and possible impact pregnancy The various disease conditions of body and/or its offspring are associated.
If n or V, regurgitation of gastric juice, dyspepsia and/or GDM increased experimenter in period of gestation, production period Between, suffer from after production or in the future in the pregnant individuals or its offspring or the risk of a certain disease occur, then be considered as N or V, regurgitation of gastric juice, dyspepsia and/or GDM are associated with the disease.
In 1 year after " in the future " can refer to production as used herein, in 5 years after production, in 10 years after producing or 20 after production It is in year or more long.
Affect pregnant individuals and the non-limiting example of the disease related to nausea and vomiting includes：Dehydration, electrolyte lose Weighing apparatus, malnutrition, venous thromboembolism, pulmonary infarction, preeclampsia, premature labor, depression, bipolar disorder and anxiety neurosis.
Affect the offspring of pregnant individuals and the non-limiting example of the disease related to nausea and vomiting includes：Baby is less than Its gestational age, or suffering from depression, bipolar disorder in the future and anxiety neurosis occurring.
Affect pregnant individuals and the non-limiting example of the disease related to GDM includes：Macrosomia, maternal infuries, premature labor, cut open palace (hereinafter referred to as cesarean) is produced, type ii diabetes is occurred after pregnancy or is occurred type ii diabetes in the future.
Affect the offspring of pregnant individuals and the non-limiting example of the disease related to GDM includes：Macrosomia, maternal infuries, shoulder Difficult labour, premature labor, the metabolic disease for reducing and/or suffering from overweight/obesity and correlation in the glucose tolerance that occurs in the future are (for example, Type ii diabetes and obesity).
In another aspect of this invention, there is provided alimentation composition of the invention, its be used for prepare for treatment or Prevention n or V, regurgitation of gastric juice, dyspepsia and/or GDM and with pregnant individuals and/or the aforementioned any one of its offspring The medicine of related disease, wherein the medicine is applied to described before pregnancy and/or during period of gestation and/or suckling Body.
On the other hand, there is provided treatment and/or prevent n or V, regurgitation of gastric juice, dyspepsia and/or GDM with And the method for the disease related to the aforementioned any one of pregnant individuals and/or its offspring, before methods described is included in pregnancy and/or Parent compositionss of the invention are applied during period of gestation and/or suckling.
The present invention will be described in still more detail by the following examples now.
Embodiment
Embodiment 1
Crossing research is devised, wherein each individuality receives all test meals.Individuality is assigned randomly to 5 kinds of tests to produce One of 10 possible random orders of product.Each individuality receives 5 kinds of research products between 5 different follow-up period, every time Follow-up is spaced at least 1 week, at most 4 weeks.Follow-up every time carries out two days (the 1st day (D1) and the 0th day (D0))：
1st day：Ingestion standard meals
0th day：
- Baseline plasma sample
- research product intake
- plasma sample-sample of breath
Individual is the healthy male of 20 to 40 years old, and BMI is 19 to 24.9kg m-2, fasting glucose is normal.
Research description
Five kinds of research products contain same amount of maltodextrin and lactalbumin, but fatty acid composition is different.It is all to grind The energy for studying carefully product accounts for 1/3rd of each individual daily energy requirement, and this is multiplied by by Harris Benedict equations Coefficient 1.5 is calculating what body movement was measured.
1. maltodextrin (43%TEI)+lactalbumin (WP, 12%TEI)
2. maltodextrin (43%TEI)+WP (12%TEI)+MUFA (39%TEI)+PUFA (6%TEI)
3. maltodextrin (43%TEI)+WP (12%TEI)+MUFA (27%TEI)+MCT (12%TEI)+PUFA (6% TEI)
4. maltodextrin (43%TEI)+WP (12%TEI)+MUFA (12%TEI)+MCT (27%TEI)+PUFA (6% TEI)
5. maltodextrin (43%TEI)+WP (12%TEI)+MCT (39%TEI)+PUFA (6%TEI).
(TEI=gross energies are taken in；WP=lactalbumins；MUFA=monounsaturated fatty acid；PUFA=polyunsaturated fat Acid；MCT=Medium-chain Triglycerides) also can be found in table 1 check meals constitute.
By 100mg 13C-Octanoate esters (French Sheng Ouban Eurisotope companies (Eurisotope, St Aubin, France in)) adding every kind of research product, to monitor gastric emptying.
Table 1：The fatty acid overview of research product
Every kind of meals are isocaloric for each individuality, and except for the difference that M1 is free from the reference diet of fat, and And containing the carbohydrate similar with other meals and protein content, but do not contain lipid.The energy of every other meals is accounted for / 3rd of each individual daily energy requirement, the energy of wherein M2 and M3 are mainly provided by Oleic acid, the energy master of M4 and M5 To be there is provided by MCT.
Table 1
Table 2：The composition of meals 1 (M1)
Table 3：The composition of meals 2 (M2)
Table 4：The composition of meals 3 (M3)
Table 5：The composition of meals 4 (M4)
Table 6：The composition of meals 5 (M5)
Research
On the same day of dynamics research, participant is on an empty stomach.There is no other dietary restrictions.
Room temperature beverage is provided with opaque cup with cover, the person of letting on was finished off in 5 to 10 minutes.
From the beginning of 1 hour before intake beverage, and blood sample is extracted in 4 hours under study for action (with further reference to Fig. 1 understandings Research overview).
Gastric emptying
In brief, test evening before that day by 100mg13C- caprylates are dissolved in test meals, to guarantee this Tracer is completely and uniform dissolution.On the same day of metabolism research, 30 minutes and 15 minutes before intake meals, two baselines are exhaled Suction sample collection is in 3 glass evacuated blood taking tubes.All test meals are absorbed in less than 10 minutes, will be defined the zero-time For end of ingesting.Using University of Wisconsin-Madison Xin Zhou Milwaukees QuinTron companies (QuinTron, Milwaukee, Wisconsin, USA) Easy Sampler Device and Crimp Tubes the 15th, 30,45,60,75,90,105, 120th, collect sample of breath within 150,180,210 and 240 minutes.
Using with gas chromatography system (GC Trace, Bremen, Germany state power ＆ light company (Thermo, Bremen, Germany isotope ratio mass spectrometer (IRMS) (Delta V Advantage, the power ＆ light company in Bremen, Germany state for)) connecting (Thermo, Bremen, Germany)) device to be analyzing breathing13CO2Sample13C enrichment conditions.By analysis and evaluation13CO2/12CO2Ratio (be expressed as δ13C, ‰).CO is calibrated according to international standard2Calibrating gas, so as to allow according to Vienna Pee De Belemnite (VPDB) is quoted13C/12The ratio of C.
It is using R softwares and non-linear to calculate using nonlinear equation change data according to the method for Ghoos et al. (2) Curve matching.Parameter T50Meas is drawn from these equations, the time is (with minute when the parameter represents Content half in stomach Meter).
Also can be found in Fig. 2 and check result.
FGF-19
FGF-19 (desmocyte growth factor-21 9) is a kind of intestinal hormoness, and which can reduce hepatic steatosis and bile is strongly fragrant Long-pending risk, and promote liver growth.Intestinal FGF19 by strengthening insulin sensitivity and can induce Glycogen synthesis, and to Fructus Vitis viniferae Carbohydrate metabolism produces beneficial effect.This hormone may additionally facilitate protein synthesis, so as to promote lean body mass to grow.
FGF19 is measured by ELISA method using the commercial reagents box from R＆D Systems.
As a result show, FGF-19 in M3 and M2 is easier to be upset, i.e., compared with the control, containing relatively low or do not contain FGF-19 of the meals of MCT contents induction of significantly higher level.Meals M4 and M5 is not significantly different from compareing.
Also can be found in Fig. 3.
Emulsification experiment
Gastric emptying method is verified using emulsification experiment.
The sample of every kind of test product (M1 to M5) is mixed by method with simulated gastric fluid equal proportion, and wherein simulated gastric fluid is by temperature Spend and constitute for the 2mg/mL NaCl and 4.5mg/mL pepsin that 37 DEG C and pH is 1.9.By using TurbiscanTMLAB, Optical turbidity (becoming with height of specimen (per 30 μm)) over time is measured at 37 DEG C, so that fat is assessed every kind of mixed Physical distribution in compound.
As a result illustrate in table 7 below.Dilute meals 3 to test its stability (meals 3 (- 10%)).
Table 7：The external condensation test result of meals
Conclusion：Meals 2 and meals 5 do not show phase separation.Meals 3 and meals 4 show slight emulsifying, and this is due to fat Fat particle aggregation is caused.This separation occurs in stomach will be relatively light, and the impact to gastric emptying is little.Estimated meals 2, Meals 4, meals 5 are not affected on gastric emptying.
Embodiment 2A：
Table 8：The embodiment of lipid blend of the invention
Embodiment 2B：
Table 9：The embodiment of lipid blend of the invention
Composition Modification 2：Without Betapol-55
Miglyol 812 -
Palm olein -
Butterfat 15.00
Betapol-55 0.00
Oleum Cocois 20.00
Canola oil 22.87
Sunflower oil 18.28
High oleic sunflower oil 21.59
ARASCO/DHASCO 1:1 1.00
ARASCO/DHASCO 2:1 1.25
Palmic acid (accounts for the percentage ratio of total fat) 7.80
Palmic acid sn-2 (accounts for the percentage ratio of Palmic acid) 20.30
Palmic acid sn-1,3 (accounts for the percentage ratio of Palmic acid) 79.70
Palmic acid sn-2 (accounts for the percentage ratio of total fat) 1.60
Palmic acid sn-1,3 (accounts for the percentage ratio of total fat) 6.20

Claims (15)

1. a kind of parent compositionss, its include for total fatty acids concentration more than 50 weight % long-chain fatty acid with And 50 weight % or less medium-chain fatty acid, for treating in pregnant mammal and/or its offspring or preventing gastric acid anti- Stream, n or V, dyspepsia, gestational diabetes and/or the disease related to aforementioned any one, wherein the parent is used Compositionss are applied to mammal before pregnancy and/or during period of gestation and/or suckling.
2. parent compositionss according to claim 1, which includes at most 5 weight % for total fatty acids concentration Medium-chain fatty acid.
3. parent compositionss according to claim 1 and 2, wherein the long-chain fatty acid is selected from：Myristic acid, Petiolus Trachycarpi Acid, palmitoleic acid, stearic acid, Oleic acid, linoleic acid, α-linoleic acid, arachidic acid, eicosenoic acid, and the combination of these materials.
4. parent compositionss according to any one of claim 1 to 3, wherein included in the parent compositionss At least 98 weight % long-chain fatty acid and/or medium-chain fatty acid be triglyceride form.
5. parent compositionss according to any one of claim 1 to 4, wherein parent compositionss are comprising relative The Palmic acid of 14 weight % is less than for total fatty acids concentration.
6., according to parent compositionss in any one of the preceding claims wherein, which is included for total fatty acids concentration Caproic acid of the concentration in the range of 0 to 1 weight %, and/or octanoic acid of the concentration in the range of 0 to 10 weight %；And/or concentration is 0 Capric acid to 10 weight %；And/or dodecylic acid of the concentration in the range of 0 to 12.0 weight %；And/or concentration is 0 Myristic acid to 0.5 weight %；And/or Palmic acid of the concentration in the range of 0 to 5 weight %；And/or concentration is 0 Palmitoleic acid to 1 weight %；And/or stearic acid of the concentration in the range of 0 to 3 weight %；And/or concentration 0 to Oleic acid in the range of 70 weight %；And/or linoleic acid of the concentration in the range of 9 to 11 weight %, and/or concentration is in 2 to 5 weights α-linoleic acid in the range of amount %；And/or arachidic acid of the concentration in the range of 0.1 to 0.5 weight %, and/or concentration 0.5 to Eicosenoic acid in the range of 1 weight %；And/or the combination in any of these materials.
7., according to parent compositionss in any one of the preceding claims wherein, which is also extracted comprising vitamin B6, Rhizoma Zingiberis Recens or Rhizoma Zingiberis Recens Thing.
8. according to parent compositionss in any one of the preceding claims wherein, wherein the compositionss are fat blends.
9. parent compositionss according to any one of claim 1 to 7, wherein the compositionss are Powdered nutritional group Compound, food product, beverage, such as powdered nutritional supplement supplementary or nutrient and healthcare products form.
10. parent compositionss according to any one of claim 5 to 9, for treatment and/or Constipation.
11. according to parent compositionss in any one of the preceding claims wherein, for purposes defined in claim 1, Wherein described mammal be selected from cat, Canis familiaris L., people mammal.
12. according to parent compositionss in any one of the preceding claims wherein, for purposes defined in claim 1, The front administration on the feed of wherein described compositionss.
13. parent compositionss according to any one of claim 1 to 9, for preparing in pregnant mammal And/or in its offspring treat or prevent regurgitation of gastric juice, n or V, dyspepsia, gestational diabetes and with aforementioned The medicine of one related disease.
14. alimentation compositions according to any one of claim 1 to 9, which is used for any one of claim 1 or 13 institute The purposes of definition, wherein the disease related to regurgitation of gastric juice, gestational diabetes and/or nausea and vomiting is selected from：Dehydration, Electrolyte imbalance, malnutrition, small for gestational age infant, venous thromboembolism, pulmonary infarction, preeclampsia and macrosomia, to mother or Maternal infuries that baby causes, shoulder dystocia, premature labor, Cesarean esction (hereinafter referred to as cesarean), pregnant mammal are stood after pregnancy Glucose tolerance reduction that is occurring and occurring at the type ii diabetes, offspring for occurring in the future and/or overweight/obesity and phase Type ii diabetes and obesity that the metabolic disease of pass, such as offspring occur, and offspring is at the depression, two-phase for occurring in the future Property mental disorder and anxiety neurosis.
Dyspepsia, regurgitation of gastric juice, trimester of pregnancy sugar are treated and/or prevented to 15. one kind in pregnant mammal and/or its offspring The method of urine disease, n or V and the disease related to aforementioned any one, it is before methods described is included in pregnancy and/or pregnant The defined parent compositionss of any one of claim 1 to 9 are applied to mammal during period and/or suckling.
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