Iron fortification nutritional blend

The present invention relates to a nutritional blend for the fortification of food products with iron, furthermore it relates to a fortified food product.

Multiple vitamin and/or mineral nutrient (so-called micronutrient) deficiency continues to be highly prevalent in developing countries and is therefore an important public health issue. Iron deficiency (or "sideropenia") is the most common known form of nutritional deficiency. The direct consequence of iron deficiency is iron deficiency anemia. Mainly children, adolescent girls and women, hare especially pregnant and breast feeding are affected. Because iron is essential for most plants and animals, a wide range of food can provide it. However, these foods are absorbed and processed differently by the body; for instance, iron from meat (heme iron source) is more easily broken down and absorbed than iron in grains (nonheme iron source), and minerals and chemicals in one type of food may inhibit absorption of iron from another type of food eaten at the same time.

Phytic acid (or phytate when in salt form) is the principal storage form of phosphorus and minerals in many plant tissues, especially bran and seeds. Phytate is found within the hulls of nuts, seeds, and grains. It is a strong chelator of important minerals such as calcium, magnesium, iron and zinc and can therefore contribute to mineral deficiencies in people whose diets rely on these foods for their mineral intake. In this way, phytate is an anti-nutrient.

Phytases are enzymes which split phytic acid (or phytate) in myo-inositol und orthophosphate and therefore increase the bioavailability of occluded minerals. Phytases are - like phytate - found within the hulls of grains and are activated by food processing like soaking, dough processing, fermentation etc.: e.g. about 50 % of the phytate complexes are split during the fermentation process in the making of whole wheat meal bread with yeast. During the production of whole rye meal bread using sourdough even all phytate complexes are split. Besides the food processing techniques themselves also physical parameters like particle size of the flour as well as pH value affect the enzymatic degradation of phytate: finely ground grist, low pH and soaking times of several hours promote the liberalization of minerals.

Unfortunately there are a lot of countries or circumstances where these techniques are not used or known and accordingly more or less unprocessed grain or other high phytate food is consumed. As the diet of refugees or people in other emergencies often contains high phytate levels, they especially suffer from mineral deficiencies. Therefore iron supplementation is often necessary and is accordingly a key for treating malnourished persons .

One way to supply malnourished persons effectively and at relatively low costs with micro- nutrients are micronutrient rich powder blends, which are added to the food by the end- consumer. Successful trials with various concepts (e.g. Sprinkles™ or others) have proven the efficacy of this approach. These formulations supply often very high levels of iron in order to overcome low bio-availability of the used iron form and/or high levels of absorption inhibitors (such as phytate) in the food.

The main disadvantage of these blends is that the iron status of the supplemented person has to be considered to avoid excessive iron intake as excessive iron can be toxic: free ferrous iron reacts with peroxides to produce free radicals, which are highly reactive and can damage DNA, proteins, lipids, and other cellular components. Thus, iron toxicity occurs when there is free iron in the cell, which generally occurs when iron levels exceed the capacity of transferrin to bind the iron.

Especially malaria infected, non-anaemic individuals may be affected by a bolus effect of free iron in the plasma (increased level of non transferrin bound iron in the plasma) if a micronutrient powder with high levels of iron is given together with a diet containing low levels of inhibitors (such as phytate). Iron supplementation has been shown to be safe in iron deficient (not iron replete) individuals living at a high risk area for malaria (Sazawal S., Black R. E., Ramsan M., Chwaya H. M., Stoltzfus R., Dutta A., Dhingra U., Kabole I, Deb S., Othman M. K., Kabole F. M. Effect of routine prophylactic supplementation with iron and folic acid on admission to hospital and mortality in preschool children in a high malaria transmission setting: a community-based, randomized, placebo -controlled trial. Lancet, 2006; 367:133-43). Accordingly, large-scale screening of the iron status under such conditions in developing countries could be a solution to the above mentioned problem, but is unfortunately not feasible for a number of reasons (analytical methods and devices suitable for the field, costs, infection risks, etc).

It was therefore an object of the following invention to provide a micronutrient blend for home fortification that meets the nutritional requirements of all malnourished persons and that can be considered as being safe, independent whether a person has malaria or not, is anaemic or not

and/or eats phytate-rich products or not. For all these various conditions a universal, safe, but as well efficient iron concept is required.

The WO-02/098442-A2 describes a composition (in particular in the form of a pharmaceutical composition, a medication or a food supplement) comprising at least one phytic acid-splitting compound - preferably a phytase - as well as its use, in particular for the increase of bioavailability of essential bio elements (in particular calcium, magnesium, zinc and/or iron, preferably in the form of their ions), but this publication could still not pave the way to the present invention.

It has surprisingly been found that the object of the present invention is achieved by a nutritional blend suitable for fortifying food containing 0.5 mg to 10 mg iron in form of a constant highly bio- available iron source, 50 FTU to 5000 FTU Phytase and at least 20 mg of Vitamin G, each per one sen.'ing; optionaiiy further containing one or more nutrients.

1 FTU (also-called FYT) is the amount of phytase that liberates 1 μmole phosphate per minute at pH 5.5 and 37 ⁰ C.

It was not to be foreseen by the person skilled in the art that a nutritional blend according to the present invention would solve the above mentioned issues. The invention describes a solution which allows a universal use of the nutritional blend, and hence saves cost and lives concurrently.

According to the present invention the nutritional blend containing the nutrients and the phytase is preferably added as a dry water dispersible powder (so-called "sprinkle") or a liquid preparation to the ready-to-eat phytate containing food (e.g. an already prepared and still warm corn porridge) before consumption, whereby the nutritional blend is mixed thoroughly with the food. This intense mixing is on the one hand beneficial for the efficacy of the phytase and on the other hand minimizes the negative impact on the taste deriving form included nutrients like minerals or specific vitamins. Thus the phytase starts immediately - i.e. already before consumption - to break down phytate and the process continues in the stomach. This procedure increases the efficacy and allows lower phytase levels e.g. compared to the state of the art described in patent WO-02/098442-A2.

Accordingly in one embodiment the invention relates to a method of providing malnourished persons, especially persons in malaria endemic areas, with micronutrients comprising the steps of a) administering a nutritional blend containing 0.5 mg to 10 mg iron in form of a bio-available iron source and 50 FTU to 5000 FTU Phytase and at least 20 mg Vitamin C, each per daily serving of the blend, optionally further containing one or more nutrients, to a ready- to-eat food immediately before consumption; and b) thoroughly mixing the blend with the food.

The term "immediately before consumption" as used herein denotes a period of time from about 1 minute to about 60 minutes, preferably from about 1 minute to about 30 minutes, more preferred from about 1 minute to about 15 minutes.

The term "bio-avaiiabie iron source" as used herein denotes physiologically harmless iron compounds, e.g. iron salts, preferably sodium iron (III) ethylenediaminetetraacetate (NaFe ³⁺ EDTA), ferrous sulphate and/or ferric pyrophosphate. NaFe ³⁺ EDTA is especially preferred.

The term "phytase" as used herein denotes phosphatases which split phytic acid in myoinositol und orthophosphate . A distinction is drawn between 3-phytase and 6-phytase according to the carbon atom at which the orthophosphate is split off the phytic acid:

3-phvtase (Enzyme EC 3.1.3.8V myo-inositol hexakisphosphate + H ₂ O = 1 D-myo-inositol 1 ,2,4,5,6-pentakisphosphate + phosphate

6-phvtase (Enzyme EC 3.1.3.26V myo-inositol hexakisphosphate + H ₂ O = 1 D-myo-inositol 1 , 2,3,4, 5-pentakisphosphate + phosphate

According to the present invention 3-phytase food grade, 6-phytase or mixtures thereof are especially preferred. The phytase of the present invention may come from plant and/or microbiological sources. A preferable plant source for phytase is malt.

The nutritional blend of the present invention may be packed either in suitable single serving packages (preferably 1 g) or in bigger units like e.g. 15O g bags (so called "multi serving packages"). In this case calibrated spoons are necessary for proper dosing.

The term "nutrient" as used herein denotes physiologically essential components of the human diet such as vitamins, e.g., vitamin A, vitamin B1 , Folic acid, Niacin, vitamin B12, vitamin B2, vitamin B6, vitamin E, C, Biotin, Pantothenates, vitamin K, vitamin D as well as derivatives and mixtures of these, as well as further minerals and trace elements such as selenium, zinc and calcium.

According to the present invention it is advantageous if the amount of nutrients present in the nutritional blend is sufficient to provide about 15 to 300 % of the RDA (Recommended Daily Allowance for an adult) in 1 g or one daily serving of the premix.

The nutrients are usually added in a powdery form, i.e. oily vitamins like vitamin A or vitamin E are preferably used as powdery product forms (e.g. as adsorbates, spray dried powders or beadlets which may contain further ingredients, like matrix components - e,g _s hydrocoϋoids - antioxidants, plasticizers, and/or emulsifiers). Even more preferred are water-dispersible powdery product forms of these nutrients.

The nutritional blend according to the present invention can be used to produce a food composition or a beverage.

The food composition may contain amino acids, other enzymes, protein, flour (e.g. malt flour), PUFA powders and so on. Polyunsaturated fatty acids (PUFAs), which are suitable according to the present invention, are mono- or polyunsaturated carboxylic acids having preferably 16 to 24 carbon atoms and, in particular, 1 to 6 double bonds, preferably having 4 or 5 or 6 double bonds. In a preferred embodiment commercially available ROPUFA® '30' n-3 Food Oil (DSM Nutritional Products Ltd, Kaiseraugst, Switzerland) is used. In another preferred embodiment of the present invention, the PUFA ester is ROPUFA ^® 75' n-3 EE. ROPUFA 75' n-3 EE is refined marine oil in form of an ethyl ester with minimum content of 72 % n-3 fatty acid ethyl ester. It is stabilized with mixed tocopherols, ascorbyl palmitate, citric acid and contains rosemary extract. In another preferred embodiment of the present invention the PUFA ester is ROPUFA® '10' n-6 Oil, a refined evening primrose oil with minimum 9 % gamma linolenic acid which is stabilized DL-alpha-tocopherol and ascorbyl palmitate.

The beverage may be a base composition to which upon its use water or another liquid beverage composition (such as milk, juice and so on) can or has to be added. The base composition can also be prepared as a concentrate to which water or another liquid beverage composition has to be added, or as a beverage to which no liquid needs to be added.

The amount of nutritional blend according to the present invention which is to be added to a food composition depends on the potency of said nutritional blend, i.e. the amount of iron and optional further nutrients in the nutritional blend .

The invention is further illustrated by the following examples.

Exampies:

Recommended intake:

One serving per person and day mixed into food with high phytate content (e.g. corn, cereals with high extraction rates, soy etc).

Example 1:

1 g (= one serving) home fortification blend contains:

Example 2:

1kg (1000 servings) contains:

Example 3:

1kg (1000 servings) contains:

About 1 g of such a blend is added to the food (to one portion) just before consumption:

Preparation:

100 g corn flour are boiled with 25Og water and 1 g salt until the water has been absorbed by the corn. The porridge is cooled down to about 60 ⁰ C or less. Then the nutritional blend is mixed into the warm porridge. The product can be consumed afterwards.