Nutritional supplement for adolescents

Drug – bio-affecting and body treating compositions – Inorganic active ingredient containing – Phosphorus or phosphorus compound

Reexamination Certificate

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C426S074000, C426S800000, C426S073000, C514S052000, C514S075000, C514S167000, C514S168000, C514S184000, C514S249000, C514S251000, C514S276000, C514S345000, C514S356000, C514S387000, C514S458000, C514S474000, C514S492000, C514S494000, C514S499000, C514S500000, C514S502000, C514S505000, C514S563000, C514S725000, C514S763000, C514S885000, C514S904000, C514S905000, C424S600000, C424S602000, C424S603000, C424S604000, C424S605000, C424S606000, C424S630000, C424S631000, C424S632000, C424S633000, C424S634000, C424S

Reexamination Certificate

active

06562378

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to nutritional supplements, and more particularly relates to nutritional supplements optimized for administration to adolescents. The invention further relates to nutritional supplements optimized for enhanced immunological response in adolescents.
BACKGROUND OF THE INVENTION
The common concept of malnutrition comes from our exposure to the print, radio, and television media showing pictures and relating stories of the horrors of severely wasted young children in low poor countries of the world, in refugee camps, and in areas affected by wars and natural disorders such as drought, famine and floods.
Although nutrient deficiencies that result in malnutrition are severe and frequent in adolescents in lesser-developed countries and in developing countries, they also often occur in adolescents even in affluent countries such as the United States, Canada, Western Europe, Japan and elsewhere. Other than the elderly in whom nutritional problems are common, adolescents are the second group most affected by nutritional deficiencies in the USA, Canada, Western Europe and other industrialized countries. For example, iron deficiency documented by appropriate blood tests is observed in as many as 20-28% of the teenagers in these countries. The prevalence of iron deficiency is higher is girls than in boys. Other nutrients found to be deficient in a proportion of adolescents are beta-carotene, vitamin C, vitamin D, vitamin E, vitamins B6, folic acid, and zinc. In the poor nations of Asia, Africa and South America, the problem is much more frequent and severe. For instance, in most parts of rural India, iron deficiency is observed in as many as 60 to 80% of boys and girls respectively. Other nutrient deficiencies are also common. There is a paucity of comprehensive and complete data for many nutrients.
These nutrient losses and deficiencies most often occur due to lifestyle factors and inadequate dietary patterns. Among other outcomes, infection is a consequence of such nutrient deficiencies, largely because malnutrition reduces immune responses.
Diets complete in nutritional substances are important for the human body in order to afford consistent high levels of optimum performance, both in cognitive ability and physical health. Although the exact needs of the human species to develop and maintain peak performance on a daily basis and sustain such performance for the various stages and throughout the duration of the human life are not completely understood, it is widely recognized that maintaining balanced nutrition coupled with sensible levels of daily exercise are the fundamental bases for optimizing the condition of the human body. It is also widely accepted that the risk of many common ailments from environmental sources or many ailments arising from genetic consequences can be reduced through the daily practice of, in addition to exercise, a complete nutritional regime fortified with certain vitamins, minerals, and the like. Increased human longevity and health is understood to be a potential consequence of these daily practices.
Vitamin and mineral preparations are also commonly administered to treat specific medical conditions, including malnutrition, or as general nutritional supplements. Studies have elucidated the important physiological roles played by vitamins and minerals, and established a correlation between deficiencies or excesses of these nutrients and the etiologies of certain disease states in humans.
It has further become recognized that various groups of the human population require different quantities and types of vitamins and minerals to prevent or alleviate diseases, as well as to maintain general good health. Much of the prior art has focused on the needs of pregnant women, particularly their need for increased iron and calcium such as that shown in U.S. Pat. No. 4,994,283, directed to nutritional mineral supplements which include iron and calcium compounds in combination with citrates or tartrates, ascorbates, and fructose in an effort to reduce the tendency of calcium to inhibit the bioavailability of iron, so that the conjoint bioavailability of these two minerals is enhanced.
The special nutritional needs of the elderly have been previously addressed in my prior U.S. Pat. No. 5,556,644 in which a multinutrient nutritional supplement was provided that was designed to be most effective in increasing the immunity and decreasing the instances and severity of infection particularly among older persons.
Efforts to address the nutritional needs of children of ages 1 to 10, such as shown in U.S. Pat. Nos. 5,719,133 and 5,719,134, have focused enteral food compositions for children between the ages of 1 and 10 having various diseases where the enteral food compositions have a the amino acid, mineral and carbohydrate profile modified to reflect the needs of children of ages 1 to 10. Such compositions are not for oral administration, and are not directed to optimizing the health of normal children and children in need of nutritional supplementation to enhance immune response and to avoid the problems of malnutrition. Furthermore, such supplements are not directed to adolescents of 13-18 years of age and their special needs.
SUMMARY OF THE INVENTION
The present invention overcomes the shortcomings of known unitary vitamin and mineral containing nutritional supplements by providing multi-vitamin and mineral nutritional supplements which are specifically tailored for administration to adolescents and provides a method for maintaining the optimal health and immunological function of adolescents by administration of the same. The formulations of the invention have been found to maximize the benefit of vitamin and mineral supplementation for adolescents, while concurrently minimizing the undesirable side effects characteristic of known nutritional supplements.
The compositions of the invention include certain essential nutritional components in dosage levels which have been found to optimize development of adolescents and maintain their health, as well as to maximize their immunological function.
Thus, the invention provides a multi-vitamin and mineral supplement for administration to adolescents, which comprises calcium in the amount of about 425 to about 575 mg; chromium in the amount of about 42.5 to about 57.5 &mgr;g; copper in the amount of about 391 to about 529 &mgr;g; fluoride in the amount of about 1.53 to about 2.07 mg; iodine in the amount of about 85 to about 115 &mgr;g; iron in the amount of about 23.8 to about 32.2 mg; magnesium in the amount of about 42.5 to about 57.5 mg; manganese in the amount of about 2.65 to about 3.45 mg; molybdenum in the amount of about 34 to about 46 &mgr;g; phosphorus in the amount of about 425 to about 575 mg; selenium in the amount of about 123.25 to about 166.75 &mgr;g; zinc in the amount of about 9.35 to about 12.65 mg; beta-carotene in the amount of about 2.04 to about 2.76 mg; vitamin A in the amount of about 637.5 to about 862.5 &mgr;g; vitamin C in the amount of about 63.75 to about 86.25 mg; vitamin D in the amount of about 9.35 to about 12.65 &mgr;g; vitamin E in the amount of about 18.7 to about 25.3 mg; thiamin in the amount of about 3.65 to about 4.95 mg; riboflavin in the amount of about 3.23 to about 4.37 mg; niacin in the amount of about 16.15 to about 21.85 mg; vitamin B6 in the amount of about 2.46 to about 3.34 mg; folate in the amount of about 340 to about 460 &mgr;g; vitamin B12 in the amount of about 3.99 to about 5.41 &mgr;g; pantothenic acid in the amount of about 1.7 to about 2.3 mg; and biotin in the amount of about 17 to about 23 &mgr;g.
An advantage of the present invention is that the adolescent nutritional supplement supplies the right amount of the necessary nutrients including vitamins and minerals to adolescents to assure optimal intake of nutrients needed for health and maximal immunological response and protection against nutritional losses and deficiencies due to lifestyle factors and inadequate dietary patterns.
Another advantage of the present in

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