Food or edible material: processes – compositions – and products – Product with added vitamin or derivative thereof for...
Reexamination Certificate
2001-10-24
2003-09-02
Pratt, Helen (Department: 1761)
Food or edible material: processes, compositions, and products
Product with added vitamin or derivative thereof for...
C426S590000, C426S656000, C426S801000
Reexamination Certificate
active
06613367
ABSTRACT:
FIELD OF THE INVENTION
The invention is related to infant formulae, i.e. artificial products for complete nutrition of infants, for improving feelings of well-being, compensation of immaturity and problems in the metabolic capacity of the infant. The nutritional products provide complete nutrition to the infant and their composition is characterised by a selected protein and carbohydrate composition and the increased amounts of folic acid, and vitamin B6 and B12 or their functional analogues.
BACKGROUND OF THE INVENTION
At present a large part of the population of babies in industrialised countries are fed with specialised infant formulae. It has been reported that consumption of these formulae is associated with several medical problems that may occur at young age, such as increased frequency of gastrointestinal problems and decreased immune status, but perhaps also at later age, because infants that are exclusively fed with human breast milk would score better on these parameters. It has also been reported that infants that are exclusively fed with these artificial formulae suffer from longer episodes of crying compared to those that are fed with human breast milk. This suggests a general feeling of discomfort due to perhaps hunger, pain or even medical problems. These problems may delay development of the child and produce concerns and practical problems to the parents.
In a first aspect of the invention it is aimed to develop a new infant formula for complete nutrition that decreases the number of crying episodes and promotes sleeping behaviour for the child, especially for infants of young gestational age.
In a second aspect it is also aimed to develop infant formulae that compensate for the relatively small capacity of the (rapidly developing) metabolic systems of the child shortly after birth. This leads to improved health, formation of higher quality new tissue (visual acuity, intellectual capacities, etc.), a better immune status and a decrease in occurrence of periods of increased bilirubin plasma levels (hyperbilirubinaemia or jaundice). Increased bilirubin levels are known to occur relatively often within the first 3 weeks after birth. Some of the negative effects of this disorder have been described in the prior art, including the inhibition by bilirubin of the uptake of the neurotransmitters dopamine and glutamate by the synaptic vesicles and the neurotoxic effects that this disease state may have.
Conventional infant formulae have been developed that mimic the composition of human breast milk to a degree that can be achieved at a reasonable price. These formulae are normally based on cow's milk proteins like casein or mixtures of casein and whey. In case of problems, such as metabolic disorders or allergic reactions, other protein sources are used like hydrolysates or soybean proteins; alternatively the allergic component is replaced by another non-allergenic ingredient. However, the composition of these formulae still differs from that of human breast milk. The relatively low levels of tryptophan and cysteine/cystine can be compensated for by increasing the amount of protein in the product. However, this increases the amount of threonine to very high levels and increases the costs of the formulae. Also the imbalances with regard to the ratio of tryptophan to the sum of the large neutral amino acids will be maintained.
In a third aspect of the invention, it is therefore aimed to develop a formula that provides amounts of tryptophan, cysteine and threonine that are more similar to the levels provided by human breast milk as an exclusive source, while at the same time the ratio of the amounts of tryptophan to large neutral amino acids in the product is more similar to the ratio observed in human breast milk. Plasma levels of the amino acids in infants that are exclusively fed with the new composition will therefore be more similar to those observed in infants that are exclusively fed with human breast milk. At the same time the costs and taste of the nutritional product will be acceptable.
Serotonin (5-hydroxytryptamine) is an important neurotransmitter, especially in the central nervous system. It also behaves as a strong contractor of smooth muscles, for example those in the arterioles and bronchioles, when released from mast cells and platelets. Serotonin is claimed to be involved in the release of peptic hormones in the gastrointestinal tract. Abnormalities in serotonin metabolism have been linked to several disorders of the central nervous system such as those related to pain, sleep and mood, either by direct action of serotonin or via its role as precursor for melatonin. Serotonin is synthesised from tryptophan by hydroxylation and subsequent decarboxylation. Tryptophan has to pass the blood brain barrier first, before it can be converted in the brain to serotonin. This passage occurs via a receptor that also transfers the large neutral amino acids.
“Large neutral amino acids” are understood to be valine, isoleucine, leucine, tyrosine and phenylalanine. In order to obtain relatively large amounts of tryptophan in the brain, competition by these amino acids has to be low and consequently the ratio of plasma concentrations of tryptophan and the sum of the large neutral amino acids has to be large.
It has been found that threonine also uses this same receptor. It is now recognised that, because of the relatively large amounts of threonine in conventional cow's milk sweet whey, the corresponding high threonine plasma levels significantly hinder the passage of tryptophan over the blood brain barrier. In a fourth aspect of the invention it is therefore aimed to provide an infant formula that ensures an increased ratio of the plasma concentrations of tryptophan to the sum of the large neutral amino acids plus threonine.
After consumption of carbohydrates, insulin is released from the pancreas. This latter component is known to reverse the catabolic processes in the body, that may have resulted from a period of starvation prior to the (re)feeding of the child, into anabolic processes. As long as sufficient glucose is present in the plasma, plasma insulin levels remain sufficiently high to prevent catabolism of (in particular muscle) tissue and the resulting release of branched chain amino acids (BCAA, valine, isoleucine and leucine). In a fifth aspect, the invention is therefore aimed at developing an infant formula that provides an insulin response on a short term, with a sufficient longer-term effect as well.
It is now recognised that the insulin response must also last until about the next feeding of the infant. Young infants are fed every 2-8 hours. It is equally important that infants maintain appetite and will eat every time a sufficient amount of food in a short time, to ensure sufficient growth. In a sixth aspect of the invention, it is therefore aimed to develop a formula that, after consumption, satisfies the infants during a period of at least 1-6 hours and preferably for a period up to 3 hours, and restores appetite of the infant after 3 hours.
Infants, especially those of young gestational age, are extremely sensitive to consumption of excess amounts of food components and imbalances in the consumption pattern of these components, predominantly due to their low relatively metabolic—and clearance capacity. This is caused by inherited problems and immaturity of their enzymatic systems and the small capacity of their organs. Infants are also sensitive to imbalances in neurotransmitter levels in the brain. It is therefore dangerous to transfer concepts that are developed for adults to infant formulae. The composition of human breast milk is therefore mostly taken as “golden standard”. In a seventh aspect of the invention a nutritional product is aimed at that does not cause any toxic reactions in normal use and to deviate as little from the golden standard as is justified.
It is important to recognise that all the aspects as mentioned above must be achieved at the same time, in order to improve well-being satisfactorily without causing negative e
Bindels Jacob Geert
Boehm Günther
Georgi Gilda
Hageman Robert Johan Joseph
Sawatzki Günther
N.V. Nutricia
Pratt Helen
Young & Thompson
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