CA2267559A1 - Cooked cereal ingredient-containing products fortified with edta/iron compositions and methods for use - Google Patents

Cooked cereal ingredient-containing products fortified with edta/iron compositions and methods for use Download PDF

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CA2267559A1
CA2267559A1 CA002267559A CA2267559A CA2267559A1 CA 2267559 A1 CA2267559 A1 CA 2267559A1 CA 002267559 A CA002267559 A CA 002267559A CA 2267559 A CA2267559 A CA 2267559A CA 2267559 A1 CA2267559 A1 CA 2267559A1
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iron
edta
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containing product
ferrous
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Sungsoo S. Cho
Luis Mejia
Louis Morel
Priscilla Samuel-Fernando
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Kellanova
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    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L7/00Cereal-derived products; Malt products; Preparation or treatment thereof
    • A23L7/10Cereal-derived products
    • A23L7/101Addition of antibiotics, vitamins, amino-acids, or minerals
    • AHUMAN NECESSITIES
    • A23FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23LFOODS, 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
    • A23L33/00Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/16Inorganic salts, minerals or trace elements
    • A23L33/165Complexes or chelates
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/06Antianaemics

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Abstract

The invention provides for a cooked cereal ingredient-containing product fortified with a composition comprising an EDTA source and an iron source that is other than ferric EDTA. The cooked cereal ingredient-containing product comprises about 1.5 to about 18 mg of total iron from the combination of the iron source and the EDTA source per ounce of said cooked cereal ingredientcontaining product, and preferably comprises 2.5 to 8.5 mg of total iron per ounce. The invention also provides for a method to prevent or treat irondeficiency anemia by administering an iron/EDTA fortified cooked cereal ingredient-containing product. The molar ratio of EDTA:iron is in the range of 1:1 to 1:4.

Description

COOKED CEREAL INGREDIENT-CONTAINING PRODUCTS
FORTIFIED WITH EDTA/IRON COMPOSITIONS
AND METHODS FOR USE
FIELD OF THE INVENTION
This invention is related to a cooked cereal ingredient-containing, storage stable product ("storage stable cereal product") fortified with iron. A combination of an EDTA source and an iron source is used to fortify the storage stable cereal product. A storage stable cereal product fortified with an EDTA source in combination an iron source combination has surprising and unexpected advantages. The combination provides a storage stable cereal product with improved iron bioavailability and is significantly less expensive than a like product fortified with ferric EDTA alone.
BACKGROUND OF THE INVENTION
Approximately one-fifth of the world's population suffer from some level of nutritional iron deficiency. Young children and women of childbearing age arc the most adversely affected by anemia and other iron deficiency related conditions. Anemia during pregnancy can lead to risk of premature labor, (Lieberman et al., Am.J.Obstet.Gyn. l59:107-I 14) and an increased perinatal morbidity and mortality, ( Bothwell et al. In Iron Metabolism in Man, 1979). Children's development may also be impaired, subsequently having an effect on their performance in school. Iron deficiency can also adversely affect productivity as seen among laborers (Edgerton et al., Brit. Med. J. 2:1546-9, 1979).
Heme iron, which is derived primarily from hemoglobin and myoglobin in meat, is transferred as intact porphyrin complex to intestinal cells, where the heme oxygenase enzyme rapidly releases the iron. It blends with other iron taken up by the cell before the regulated transfer to the blood stream occurs. This form of iron is readily absorbed and is generally not affected by the contents of the meal with which the heme containing food is consumed. The non-heme iron has a heterogenous origin, being derived from vegetable foods and inorganic forms of iron, and can be used to fortify foods by increasing the level of iron present.
AMENDED SHEET (ARTICLE 19) Non-heme iron, which is derived from plant foods and fortified foods is not as well absorbed as heme (meat) iron. Furthermore, beverages such as coffee and tea consumed at meal time and other factors can contribute to poor absorption of non-heme iron.
The addition of ascorbic acid or vitamin C to shelf stable cereal based products can enhance iron absorption in the diet, generally without affecting consumer acceptability.
However, ascorbic acid fortification is expensive and when exposed to oxygen and moisture can be unstable during storage. In cases where food preparation involves baking, prolonged boiling or reheating, ascorbic acid is unstable and is partially lost.
The most efficient and cost-effective way of preventing and treating iron deficiency is to fortify food products with a form of iron that provides for adequate absorption. While cost is not necessarily a controlling factor in whether an affluent consumer would purchase an iron fortified product. among the poor and in less-well developed countries cost often becomes the controlling factor. Currently used iron fortificants, such as ferrous sulfate, are bioavailable, however they adversely affect the organoleptic properties of the cooked cereal ingredient-containing storage stable products, (hereinafter referred to as storage stable cereal products}.
Therefore, other readily available and inexpensive sources ofiron, which do not adversely affect the organoleptic properties of the storage stable cereal products are desirable. Other inexpensive sources of iron, such as reduced iron and iron orthophosphate have the disadvantage that the iron is not as bioavailable as is the iron in ferrous sulfate and ferric EDTA.
Applicants have discovered that the bioavailabil.ity of total iron can be enhanced by combining sources such as reduced iron or iron orthophosphate with an EDTA source such as ferric EDTA or another sodium EDTA, such as disodium EDTA and calcium disodium EDTA. Surprisingly, the ratio of EDTA to iron source may also influence the bioavailability of the iron.
U.S. patent no. 5,534,274 (incorporated by reference) discloses that ferric EDTA is suitable for fortifying storage stable cereal products and that it may be combined with other fortificants, e.g., reduced iron. The patent suggests multiple iron sources, such as ferric EDTA
with an additional iron fortificant such as ferrous fumarate, ferrous sulfate, reduced iron, ferric citrate, ferrous citrate, ferrous lactate, ferrous succinate, fernc phosphate, ferrous gluconate, ferrous pyrophosphate, ferrous glutamate, fernc tartrate, ferrous carbonate, ferric chloride, ferric ammonium citrate, ferrous ascorbate, ferrous glycinate, ferrous malate, and ferrous cholinisocitrate and other similar ferric or ferrous compounds which would be readily AMENDED SHEET (ARTICLE 19) determinable by those skilled in the art may be combined to fortify the products. That patent does not suggest using ferric EDTA to enhance the bioavailability of the iron sources.
Furthermore, the patent does not suggest that other EDTA sources could also be used in combination with an iron source in shelf stable cereal products to enhance iron bioavailability.
Fernc EDTA is a pale yellow water-soluble powder that can be added to many food vehicles. In addition, when ferric EDTA is consumed with foods containing large quantities of absorption inhibitors, iron is protected from agents which inhibit its absorption. Iron from ferric EDTA has been reported to be two to three times more bioavailable than iron presented as a FeSOa complex in some diets. Furthermore, ferric EDTA is more stable under adverse storage conditions and is unaffected by cooking.
Ferric EDTA is used in a variety food ingredients or condiments, i.e., fish sauce in Thailand (Garby et al., 1974, Ann. Tro. Med. Parasitol. 68:467-76), curry powder in South Africa (Macphail et al. , Experimental Fortificants, in: Clydesdale FM et al.
eds. Iron Fortification of Foods, 1985), Egyptian flat bread (Guindi et al., Brit. J.
Nutr. 59:205-213, 1988), sugar in Guatemala (MacPhail et al., Br. J. Nutr. 45;21 S-227, 1981 ).
Absorption of iron in dietary foods such as flat breads has also been studied in Guindi et al., 1988, cite monograph table.
Sodium EDTAs are safe for use in food products. (Iron EDTA for Food Fortification:
A Report of the International Nutritional ANEMIA Consultative Groun, The Nutrition Foundation, Inc., Bates et al. Eds ( 1993)). Disodium EDTA, a white, water soluble chelating agent, is deemed to be safe for use in aqueous multi-vitamins. a variety of canned foods including peas, beans, pie fillings, salad dressings) frozen potatoes, mayonnaise, and dried bananas used in ready-to-eat breakfast cereals. Disodium EDTA is used to promote color retention and as a preservative. It is also used as a cure accelerator in cooked sausages.
Additionally, calcium disodium EDTA is used to promote color, flavor, and texture retention in pickled cucumbers and cabbage, in canned foods, such as carbonated soft drinks, white potatoes, clams, mushrooms, beans, and in dry processed foods, such as pinto beans and lima beans. It is also used as a preservative in foods, such as salad dressings, oleomargarine, and potato salad.
In addition, calcium disodium EDTA is used to retard struvite formation in sea foods, such as canned crabmeat and shrimp, and to promote stability of color, flavor and/or clarity of distilled alcoholic beverages. However, prior to this invention, food products were not fortified with AMENDED SHEET (ARTICLE 19) combinations of disodium EDTA or other EDTA salts with an iron source such as reduced iron to enhance iron bioavailability.
This is the first known use of a composition comprising an EDTA source, such as ferric EDTA, calcium disodium EDTA, or disodium EDTA, and an iron source, other than fernc EDTA, to fortify a storage stable cereal product by enhancing the bioavailability of iron from the iron source.
The storage stable cereal product is prepared with the iron and EDTA
combination by either incorporating it into the cereal dough mix prior to cooking or by spraying an iron/EDTA
solution onto the finished storage stable cereal product. The combination ofthe iron source and the EDTA source results in unexpectedly enhanced iron bioavailability over a like product fortified with reduced iron alone. It does not adversely affect taste and maintains excellent brightness characteristics and oxidative stability, as well as having a significant reduction in cost over a like product fortified with ferric EDTA alone. These unexpected properties for the iron/EDTA fortified storage stable cereal product described above have not been established 1 S prior to this application.
Thus, it is a principal object of this invention to provide for a storage stable cereal product, which is fortified with an EDTA source, such as fernc EDTA, calcium disodium EDTA, tetrasodium EDTA, trisodium EDTA, or disodium EDTA, in combination with an iron source, such as reduced iron or iron orthophosphate. The use of iron/EDTA combination as an iron fortificant in a storage stable cereal product produces a product which is organoleptically acceptable to consumers. The color, odor, and taste of the product are not adversely affected by the addition of the combined iron source and EDTA source and the bioavailability of the iron in the storage stable cereal product appeared not be adversely affected by the other constituents of cereals, which might inhibit the absorption of iron.
It is a further object of the invention to provide a method to prevent or to treat iron-deficiency anemia by administering the storage stable cereal products to individuals or population groups in need of such treatment.
This invention also relates to fortifying storage stable cereal products with combinations of EDTA salts and other minerals, such as calcium, magnesium, zinc, selenium and copper and to methods for supplementing diets that are inadequate in these minerals.
AMENDED SHEET (ARTICLE 19) This invention provides for a storage stable cereal product, which is fortified with an EDTA source, such as ferric EDTA, calcium disodium EDTA, tetrasodium EDTA, trisodium EDTA, and disodium EDTA, and an iron source, such as reduced iron or iron orthophosphate.
S Fortifying a storage stable cereal product with the EDTA, such as ferric EDTA or calcium disodium EDTA in combination with an iron source yields surprising results in a novel storage stable cereal product. The storage stable cereal products' organoleptic qualities, i.e., its color, odor, stability, and taste, are unaffected by the combination ofthe iron source and EDTA source.
Further, the bioavailability of the iron is unexpectedly enhanced by the EDTA
source.
The total iron content in the storage stable cereal product ranges from 1.5-18 mg per ounce of cereal product, or preferably 2.5-8.5 mg/ounce of cereal product. The preferred ratio on a molar basis of EDTA to iron ran;~es from 1:1 to 1:4 more preferably 1:1 to 1:2.
The invention also provides for a method ofpreventing or treating iron-deficiency anemia by administration of the ford Pied storage stable cereal product of this invention to those in need of such treatment.
This invention also relates to enhancing the bioavailability of other minerals, such as calcium, zinc, copper, selenium and magnesium by fortifying a storage stable cereal product with a combination of an EDTA source and a mineral source, such as calcium, zinc, magnesium, selenium, or copper.
DETAILED DESCRIPTION OF THE INVENTION
Figure 1 demonstrates the hemoglobin iron change for rats fed diets comprising EDTA:Iron at various concentrations of iron per kg diet.
Figure 2 demonstrates the hemoglobin iron change over two weeks for rats fed diets comprising reduced iron and FeOP on an equal cereal basis.
Figure 3 demonstrates the hemoglobin iron change over two weeks for rats fed diets comprising FeS04, reduced iron, or FeOP and mixtures thereof at various concentrations of iron per kg diet.
Figure 4 demonstrates the hemoglobin iron change over nvo weeks for rats fed diets comprising various mixtures/combinations of iron sources and EDTA sources at various concentrations of iron per kg diet.
A1VIENDED SHEET (ARTICLE 19) Adding an iron source, such as reduced iron or iron orthophosphate, and an EDTA
source, such as ferric EDTA or a disodium EDTA, at a molar ratio of about I :4 (EDTA:iron) to about 1:1 (EDTA:iron) to fortify a storage stable cereal product has not been reported prior to this invention. The Examples infra demonstrate that the combination of an EDTA
source with an iron source enhances iron bioavailability.
A storage stable cereal product is unusual in that during its preparation the iron fortificant may be added to a cereal dough product, which is cooked/heated and formed into cereal pieces, or alternatively the iron fortificant may be sprayed onto the formed cereal pieces. The cereal pieces are then dried and stored for a potentially long period of time.
Although the storage stable cereal product is not generally subjected to any further cooking means prior to consumption, it may be subjected to conditions that destabilize the storage stable cereal product containing the iron fortificant. Oxidation of the iron fortificant may adversely affect the overall characteristics of the product. Therefore, the stability of any iron fortificant added to a storage stable cereal product is extremely important to the palatability and physical acceptability ofthe product to the consumer.
The advantages of using a combination of an iron source and an EDTA source to fortify a storage stable cereal product include enhancing iron bioavailability) and doing so in a cost-effective manner, and producing a cereal product that has high intensity on the brightness scale, a pleasing taste and oxidative stability.
A storage stable cereal product includes not only ready-to-eat breakfast cereals) such as Corn Flakesr~ and Rice KrispiesY. but also includes other food products, such as snack bars, such as NurtriGrain~ bars and Rice Krispies TreatsT"'' Squares, toaster pastries, such as PopTarts~, and pastry products, which are produced using cooked cereal ingredients. These storage stable cereal products can be fortified in the same manner with the combination of an iron source and an EDTA source as described herein.
The storage stable cereal products of this invention may be prepared from cereal ingredients selected from the group consisting of wheat, rice, oat, corn, barley, rye, millet, sorghum, amaranth seed and mixtures thereof. Furthermore, other ingredients, including but not limited to, sugars, salts, spices, flavorings, fruits, nuts, vitamins and minerals, which may add to the flavor or nutritional aspects of the final product, may be added to the storage stable cereal product without departing from the spirit and scope of the invention. In addition, high fiber AMENDED SHEET (ARTICLE 19) sources, such as psyllium as disclosed in U.S. patent no. 5,227,248 and incorporated herein by reference in their entirety, may also be included in the storage stable cereal products.
The iron fortified storage stable cereal products of this invention may also be administered to individuals or population groups to prevent or treat iron-deficiency anemia, i.e., a low hemoglobin value, a low hematocrit value or a low red blood cell count.
The storage stable cereal products of this invention, may also be used to supplement a diet that is inadequate in minerals, such as calcium, magnesium, zinc, copper, and selenium.
This invention will be better understood by reference to the following examples, which establish a greater relative iron bioavailability by fortifying storage stable cereal products with an iron source that is not ferric EDTA with an EDTA source. These examples are included here for purposes of exemplification and are not to be construed as limitations.
Example 1 1 S The relative iron bioavailabi lity of various iron containing compositions in a ready-to-eat cereal product was assayed using a widely accepted method, commonly referred to as the rat hemogiobin repletion method, (modified AOAC method for assessment of relative iron bioavailability), see Williams, S. ed. Official methods of analysis of the Association of Official Analytical Chemists, 14th ed. Arlington, VA. AOAC, 1984; Fritz, J.C. et al., Collaborative Study of rat hemoglobin repletion test for bioavailability of iron, AOAC l974, 57:513-517.
Relative bioavailability of the various iron:EDTA composition was carried out in a series of separate experiments. In each of these experiments, ferrous sulfate was used as the standard or control compound.
Sprague Dawley rats, individually housed in temperature and light controlled units, were fed an iron deficient diet obtained from Harland Tekland Laboratories for 24 days. After this iron depletion phase, the rats were weighed and blood was drawn to test for baseline hemoglobin concentrations. These anemic animals, with hemoglobin levels between 2.9 to 4.1 g/i, were then randomly assigned to the control and test groups. Ferrous sulfate, reduced iron and the fernc EDTA compounds were added to the test diets to achieve concentrations of 6 and 18 and 24 mg iron/kg diet. These diets were then fed to groups of ten animals, ad libitum, for 14 days. Iron levels in the diets, were verified by atomic absorption spectrometry (Blin et al., J. Assoc. Off.
AMENDED SHEET (ARTICLE 19) Anal. Chem. 1977, 60:I 170-1174). After the 14-day test period, hemoglobin concentrations were determined for a11 animals.
The iron bioavailability of each iron source, assayed relative to ferrous sulfate, was calculated using the slope ratio procedure by comparing the gain in hemoglobin concentration S with the iron concentration in the diet (Finney, D.J., Statistical methods in biological assay. 2nd ed. 1964; Amine et L., Biological assessment of available iron in food products, J. Agric. Food Chem. 1974, 22:470-476). Intercept and slope estimates were obtained for the rats fed diets that were not fortified (negative controls) and rats fed each test diet using the ordinary least square's method. All test diet intercepts were compared to the negative control diets to validate the fitting of a common intercept. Comparison of the slopes of the test diets with the standard (ferrous sulfate) diet was performed after fitting the data through a common intercept.
Bioavailability was defined as the ratio of the slope of each diet to the slope of ferrous sulfate diet. The statistical program SAS V.608 was used. The slope values and ratios are set forth in Table 1.
Table 1 Iron Source Slope Value Ratio Ferrous Sulfate 0.33+0.02* 1.00 Ferric EDTA 0.31 +0.03 * 0.94 Reduced Iron 0.16+0.03* 0.48 * = 95% confidence interval The slope of the line generated from ferric EDTA is similar to that from the ferrous sulfate standard. The slope value for the reduced iron diet was markedly less than the value for fernc EDTA. These data indicate that the iron from ferric EDTA is absorbed at a rate not significantly different from ferrous sulphate and significantly better than reduced iron.
AMENDED SHEET (ARTICLE 19) Example 2 To compare the bioavailability of iron from varying ratios of EDTA:Iron (1: I, 1:2, I:3 and I :4) with the bioavailability of iron from l00% reduced iron and from 100% ferrous sulfate, Sprague Dawley rats were fed the above diet at various levels, 0, 10, 16, 29 and 50 mg, iron per kg of total diet'. The relative iron bioavailability was accessed by the rat hemoglobin repletion test AOAC method as described in Example I s-u~ra. The slopes value and the intercepts values are set forth in Table 2.
Table 2: Intercept and Slope Comparisons Among Treatments (Study 6706-102) l 2 3 4 5 6 7 Treatment b0 se bl se Ratio means Ratio of EDTA/IRON (I) (level=50)means None -2.01 NA NA NA NA NA NA

FeSO.~ -2.55 0.35 0.27a 0.02 - 7.22ab -I:1 -2.88 0.25 0.23b 0.01 85.2 7.29a l00.0 1:2 -2.33 0.28 0.21c 0.01 77.8 7.10ab 98.3 i :3 -2.92 0.26 0.19ed 0.0I 70.3 6.21 be 86.0 1:4 -2.59 0.2l 0.17d 0.01 G3.0 6.05c 83.8 100% reduced -2.76 0.l5 0.14e 0.01 51.9 4.31d S9.7 iron !~AOAC Standard requires; 0, 6, 12, 24. Although the study was designed to be 0, 6, 12, 24, and 28, the real numbers (0, 10, I6, 29 and 50) are due to the variation in preparation of the diets.
AMENDED SHEET (ARTICLE 19) 1. Expected hemoglobin change when there is no added iron (intercept).Z
2. Estimates of standard error of intercepts.
3. Estimates of hemoglobin change for every unit increase in added iron (slope; obtained after fitting a common intercept).z 4. Estimates of standard errors of slopes.
5. Ratio of treatment slopes to the slope of FeS04.
6. Average hemoglobin change at SO mg/kg diet of added iron.
7. Ratio of the treatment means at 50 mg/kg diet of added iron to the mean hemoglobin change of FeS04.
Linear regression suggests that the total change in hemoglobin (g/dL) in rats fed diets fortified with 1:1 and 1:2 EDTA:iron were significantly higher than the hemoglobin change observed when the rats were fed a diet fortified with only reduced iron as the iron source (diets fortified with 100% FeS04 ser<-ed as the standard).
At 50 mg Fe/kg diet, the change in hemoglobin among rats fed the 1:1 test diet is not significantly different from the hemoglobin change in rats fed the reference FeS04 diet.
Additionally, the hemoglobin change for rats fed a I :2 test diet is not significantly different from rats fed the 1: I and the FeSO, diets. Although the hemoglobin change for rats fed a 1:3 diet is significantly different from those fed the I:I and FeSOa diets, the change is still significantly higher than the values in rats fed diets fortified with just reduced iron.
Table 2 and Figure I indicate that combining disodium EDTA with reduced iron enhances the bioavailability of the iron as measured by the average hemoglobin change (g/dL) relative to the amount of added iron (mg/kg diet). The ratio percent are calculated based on the hemoglobin change for the standard, ferrous sulfate. The bioavailability of reduced iron alone is 51.9% while the ratio% of the iron bioavailability in a test diet comprising EDTA:iron at 1:4 is 63%. This is a significant difference (P< .10). As the ratio of EDTA to iron in the test diet increases so does the bioavailability of the iron until, at an EDTA:iron ratio of 1:2 or 1:1, and ?~ Slopes of means associated with different letters are significantly different from each other (P<.10).
AMENDED SHEET (ARTICLE 19) a total of 50 mg Fe/kg diet, the bioavailability of iron provided by the EDTA:iron is not significantly different from the bioavailabi(ity of iron provided by ferrous sulfate.
Example 3 Rats were fed a purified rat diet/Corn Flakes~ fortified with ferric orthophosphate either alone or in combination with reduced iron or disodium EDTA or mixtures of both. The iron bioavailability in the ferric orthophosphate fortified diets were compared to the iron bioavailability in diets fortified with reduced iron or ferrous sulfate. As described above the bioavailability was determined by assaying the relative change in hemoglobin in rats fed with the various fortified diets.
Six test diets were evaluated:
A) 45% RDA reduced iron B) 20% RDA reduced iron/25% RDA FeOP
I S C) 20% RDA reduced iron/50% RDA FeOP
D) 45% RDA FeOP
E) 45% RDA FeOP - EDTA ( 1:1 Fe:EDTA) F) 20% RDA reduced iron/25% RDA FeOP - EDTA ( I :1 Fe:EDTA) All products, except the product with additional FeOP (C), were fed at levels equivalent to 6, 12, 24 and 48 mg Fe/kg diet. The product with additional FeOP (C) was fed at an equal cereal level to the other test diets resulting in 9.4, 18.7, 37.4, and 74.9 mg Fe/kg diet.
The results depicted in Tables 3 and Figures 2, 3, and 4 indicate that: ( 1 ) there was no statistically significant difference in the iron absorption (i.e.
slope/relative bioavailability) of FeOP and reduced iron (see Table 3); and (2) the addition of disodium EDTA
greatiy improved bioavailability, approximately doubling bioavailability, and approached the bioavailability obtained with the reference FeS04.
AIViENDED SHEET (ARTICLE 19) Table 3: Intercept and Slope Comparisons Among Various Iron Sources in Corn Flakes~
Iron InterceptIntercept Slope Slope Source Differences' Differences' None -l.40 a NA NA

A) Reduced Iron -1.73 a 0.11 a (45% RDA) B) Red.Iron/FeOP -1.73 a 0.10 a (20% / 25% RDA) D) FeOP -l.82 a 0.10 a (45% RDA) E) FeOP - EDTA -2.16 a 0.22 b (45% RDA 1:1 Fe:EDTA) F) Red. Iron/FeOP - EDTA -2.03 a 0.24 b (20% / 25% RDA 1:1 Fe:EDTA) FeSO.~ -2.10 a 0.30 c C) Red.Iron/FeOP -2.07 NA 0.l0 NA

{20% / 50% RDA) 'Estimates with the same letter do not di ffer (P<0.10).
At an iron concentration of 48 my Fe/kg diet, the absorbed iron began to plateau for the products having high bioavailability (FeSO., and the two products containing EDTA {E) and (F)).
This is demonstrated in Figure 3.
The animals fed Corn Flakes"~ fortified with reduced iron generally had slightly greater increases in absorbed iron than the animals fed equal amounts of FeOP
fortified Corn Flakes~
or the Corn Flakes~ fortified with reduced iron and FeOP. As shown in Table 3, the slope of the iron absorption line for reduced iron was approximately 10% greater than reduced iron and FeOP
(0.11 vs. 0.10). However, the addition of Naz EDTA to Corn Flakes'' fortified with FeOP alone or reduced iron in combination with FeOP ( 1:1, EDTA:Iron) greatly improved the bioavailability of iron. The relative bioavailability was roughly twice that of similar products without Naz EDTA. EDTA improves the bioavailability of other iron sources in cereal as seen in Figure 4.

AMENDED SHEET (ARTICLE 19) It is not intended that the present invention be limited to only the described embodiments.
Rather, the invention should be circumscribed by the scope of the appended claims.

AMENDED SHEET (ARTICLE 19)

Claims (19)

We claim:
1. A cooked cereal ingredient-containing product comprising:
a) a cereal ingredient;
b) an EDTA source, and;
c) an iron source other than ferric EDTA.
2. The cooked cereal ingredient-containing product of claim 1, wherein said EDTA source is a sodium EDTA.
3. The cooked cereal ingredient-containing product of claim 1, wherein the ratio of EDTA
to iron is 1:1 to 1:4.
4. The cooked cereal ingredient-containing product of claim 2, wherein said EDTA source is selected from the group consisting of a NaFeEDTA, Na2EDTA, trisodium EDTA, tetrasodium EDTA, and calcium sodium EDTA.
5. The cooked cereal-ingredient-containing product of claim 1, comprising about 1.5 to about 18 mg of total iron from the combination of the iron source and the EDTA
source per ounce of said cereal product.
6. The cooked cereal ingredient-containing product of claim 1, comprising about 2.5 to about 8.5 mg of total iron from the combination of the iron source and the EDTA source per ounce of said cereal product.
7. The cooked cereal ingredient-containing product of claim 1, wherein said cereal ingredient is selected from the group consisting of wheat, rice, oat, corn, barley, rye, millet, and amaranth seed.
8. The cooked cereal-ingredient-containing product of claim 1, further comprising at least one iron fortificant selected from the group consisting of ferrous fumarate, ferrous sulfate, reduced iron, ferric citrate, ferrous citrate, ferrous lactate, ferrous succinate, ferric phosphate, ferrous gluconate, ferrous pyrophosphate, ferrous glutamate, ferric tartrate, ferrous carbonate, ferric chloride, ferric ammonium citrate, ferrous ascorbate, ferrous glycinate, ferrous malate, and ferrous cholinisocitratem, encapsulated iron and ferric orthophosphate.
9. The cooked cereal ingredient-containing product of claim 1, wherein the product is a R-T-E breakfast cereal.
10. The cooked cereal ingredient-containing product of claim 1. wherein the product is a toaster pastry.
11. The cooked cereal ingredient-containing product of claim 1, wherein the product is a snack bar.
12. A method for preventing iron-deficiency anemia in a subject comprising administering to said subject an amount of the cooked cereal ingredient-containing product of claim 1, sufficient to prevent said anemia in said subject.
13. A method for preventing iron-deficiency anemia in a subject comprising administering to said subject an amount of the cooked cereal ingredient-containing product of claim 7, sufficient to prevent said anemia in said subject.
14. A method for treating iron-deficiency anemia in a subject comprising administering to said subject an amount of the cooked cereal ingredient-containing product of claim 1, sufficient to treat said anemia in said subject.
15. A method for treating iron-deficiency anemia in a subject comprising administering to said subject an amount of the cooked cereal ingredient-containing product of claim 5, sufficient to treat said anemia in said subject.
16. A grain based cereal product organoleptically acceptable for human consumption comprising:
a) a cooked grain product;
b) an EDTA source, and:
c) a mineral source.
17. The grain based cereal products of claim 15, wherein the mineral is selected from the group consisting of calcium. potassium, magnesium, copper, selenium, and zinc.
18. A method for treating iron-deficiency anemia in a subject comprising administering to said subject an amount of the cooked-cereal ingredient containing product of claim 8, sufficient to treat said anemia in said subject.
19. A method for preventing iron-deficiency anemia in a subject comprising administering to said subject an amount of the cooked cereal ingredient-containing product of claim 8, sufficient to prevent said anemia in said patient.
CA002267559A 1997-08-01 1998-07-31 Cooked cereal ingredient-containing products fortified with edta/iron compositions and methods for use Abandoned CA2267559A1 (en)

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US5442897P 1997-08-01 1997-08-01
US60/054,428 1997-08-01
PCT/US1998/016036 WO1999005920A1 (en) 1997-08-01 1998-07-31 Cooked cereal ingredient-containing products fortified with edta/iron compositions and methods for use

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JP (1) JP2001507579A (en)
KR (1) KR20000068686A (en)
AR (1) AR013274A1 (en)
AU (1) AU8764198A (en)
BR (1) BR9806080A (en)
CA (1) CA2267559A1 (en)
CO (1) CO5040031A1 (en)
GT (1) GT199800002A (en)
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JP3740295B2 (en) 1997-10-30 2006-02-01 キヤノン株式会社 Carbon nanotube device, manufacturing method thereof, and electron-emitting device
US6461651B1 (en) 2000-09-26 2002-10-08 General Mills, Inc. Sodium-free iron complex for food fortification
JP2005325080A (en) * 2004-05-17 2005-11-24 Daiichi Fine Chemical Co Ltd Composition containing calcium pantothenate and vitamins
WO2012097155A1 (en) * 2011-01-14 2012-07-19 Chiasma Inc. Improved pharmaceutical compositions for delivery of ferric iron compounds, and methods of use thereof

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CO4410161A1 (en) * 1994-02-28 1997-01-09 Kellog Co READY-TO-EAT CEREAL PRODUCT FORTIFIED WITH EDTA FERRICO COMPLEX AND METHOD FOR PRODUCING IT

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EP0966209A1 (en) 1999-12-29
KR20000068686A (en) 2000-11-25
JP2001507579A (en) 2001-06-12
GT199800002A (en) 1999-06-29
WO1999005920A1 (en) 1999-02-11
AR013274A1 (en) 2000-12-13
AU8764198A (en) 1999-02-22
BR9806080A (en) 1999-08-24
TR199900870T1 (en) 1999-10-21

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