Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Food or edible as carrier for pharmaceutical
Reexamination Certificate
2001-06-12
2003-01-28
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Food or edible as carrier for pharmaceutical
C424S400000, C424S489000, C424S725000
Reexamination Certificate
active
06511675
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to a composition and method for correcting a dietary inadequacy, including a diet-induced inadequacy, of phytochemicals, vitamins, and minerals.
BACKGROUND OF THE INVENTION
Dietary supplements are often used for the treatment and prevention of various disorders. Such supplements are often targeted for specific diseases. For example, U.S. Pat. No. 5,976,568 is directed to a modular system of dietary supplement compositions for the treatment and prevention of, among other things, coronary heart disease. The modular system comprises several different modules, or formulas, each of which is a different combination of vitamins and minerals such as antioxidants and folic acid.
Similarly, U.S. Pat. No. 5,830,887 relates to compositions enriched with natural phytoestrogens selected from genistein, daidzein, formononetin, and biochanin A. The compositions are disclosed to be useful for promoting health in cases of cancer, pre-menstrual syndrome, menopause, or hypercholesterolemia.
U.S. Pat. No. 5,882,646 relates to a brassica vegetable supplement having high levels of sulforaphane and low levels of sulforaphane-nitrile. Brassica vegetables include, for example, broccoli, cabbage, kale, and cauliflower. The brassica vegetable supplements allow consumers who don't like the taste of brassica vegetables to nevertheless reap the dietary benefits therefrom.
U.S. Pat. No. 5,770,217 is directed to a dietary supplement comprising herbs and herbal extracts, vitamins, minerals, and amino acids effective in modulating hematological toxicities, enhancing the immune system, and maintaining appetite and weight.
A large portion of the population does not practice desirable eating habits, namely an adequate intake in quantity and variety of food to meet the U.S. Recommended Dietary Allowances. Only 22% of the subjects of a National Cancer Institute Study consumed the recommended daily number of dietary servings of fruits and vegetables. This is in spite of the fact that the recommended dietary intake of fruits and vegetables is well-known. For example,
The California Daily Food Guide: Dietary Guidelines for Californians,
California Department of Health Services (1990) recommends that each person consume at least five to nine servings of fruit and vegetables per day, including one serving of a vitamin A-rich deep green or dark orange fruit or vegetable, and at least one serving of a vitamin C-rich fruit or vegetable. Additionally, each person should consume at least 3 servings per week of vegetable protein in the form of legumes, nuts, or seeds. Some researchers suggest that a target of 400 grams (13 ounces) of fruits and vegetables is a sensible goal for the optimal quantity to be consumed daily. In terms of variety, persons should eat at least three different colors of fruits and vegetables daily.
Lifestyle factors such as smoking, levels of physical activity, exposure to toxic environmental compounds, dieting, use of certain medications such as oral contraceptives, the use of certain food additives such as OLESTRA, and the avoidance of certain foods (for example, due to lactose intolerance, which occurs in over 25% of the population), can also contribute to low or deficient intakes of nutrients.
Although researchers haven't yet ascertained the optimal plant-based diet, it's clearly one that is rich in fruits and vegetables. It is believed that the optimal diet comprises, in large part, the following nine plant foods (and phytochemicals).
Red, yellow, and orange fruits, which are rich in, for example, carotenoids, flavonoids, and coumarins;
Red, yellow, and orange vegetables, which are rich in carotenoids, flavonoids, and capsaicin;
Cruciferous and leafy green vegetables, which are rich in indoles, carotenoids, and isothiocyanates;
Soy and soy products which are rich in flavonoids, phytosterols, saponins, and protease inhibitors;
Garlic, which is rich in allyl sulfides and quercetin;
Beans and other legumes, which are rich in phytosterols, isoflavones, protease inhibitors, and saponins;
Whole grains, which are rich in lignans, phenolic acids, and phytosterols;
Nuts and seeds, which are rich in lignans; and
Tea (green or black), which is rich in the catechin flavonoids.
It is difficult, if not impossible, to make diet recommendations on the precise quantity of each plant or its constituents that prevent diseases or alter disease progression. Nevertheless, leading health authorities offer dietary guidelines for general health promotion and disease risk reduction.
Research has shown that the typical U.S. diet is lacking in phytochemicals. Phytochemicals generally refer to plant-derived compounds which, when taken daily in combination with vitamins and minerals, provide improved cardiovascular and bone health, an improved antioxidant profile, decreased free radical damage, and overall enhancement of the body's natural defense system. The difference between the recommended amount of phytochemicals and the amount ingested in a typical diet is referred to as, for the purposes of the present invention, a gap. The following table represents a gap analysis for various phytochemicals.
Phytochemical
Recom. Level
Typical U.S. Diet
Gap
Total Carotenoids
9-18 mg/day
6.0 mg/day
3-12 mg/day
&bgr;-carotene
3-13 mg
2.6 mg
0.4-10.4 mg/day
Lutein
19.5-25.6 mg
1.8 mg
20.75 mg
Lycopene
4.2-10 mg
2.2 mg
2-7.8 mg
Total Flavonoids
0-1500 mg/day
1000 mg/day
100 mg/day
Isothiocyanates
19-38 mg/day
0 mg
19 mg
Isoflavones
48-60 mg/day
0.1-20.3 mg/day
33.7-53.9 mg/day
The existence of this gap has significant health implications, as the link between ingestion of phytochemicals and a decreased incidence of several chronic degenerative diseases, such as cancer and cardiovascular disease, has been demonstrated. For example, in a case-cohort study of 8006 Hawaiian men of Japanese ancestry, the association between diet and the risk of gastric cancer was investigated. Dietary data obtained from 111 men with stomach cancer and 361 cancer-free men were analyzed for intake of selected foods, food groups, and nutrients. The researchers reported that the consumption of all types of vegetables exhibited a statistically significant inverse trend with gastric cancer risk. Green and cruciferous vegetables exhibited a similar but weaker protective effect. Chyou, P. H. et al., “A Case-Cohort Study of Diet and Cancer,”
Cancer Res.
50:7501-4 (1990).
In a prospective cohort study of 41,837 postmenopausal women, the association of fruit and vegetable consumption with lung cancer risk was investigated. The researchers found that the risk of lung cancer was approximately halved when the consumption of fruits and vegetables increased from 24 or less servings to an excess of 48 servings per week. Similarly, the risk of lung cancer was approximately halved when the consumption of green leafy vegetables, including spinach and parsley sources, increased from 1 or fewer servings to six or more servings per week. Steinmetz, K. et al., “Vegetables, Fruit, and Lung Cancer in the Iowa Women's Health Study,”
Cancer Res.
53:536-43 (1993).
Another study found that an increased intake of fresh tomatoes (a major source of lycopene) was associated with a pattern of protection for all sites of digestive tract cancer. Stahl, W. et al., “Lycopene: A Biologically Important Carotenoid for Humans?”
Arc. Biochem. Biophys.
336:1-9 (1996).
A case-controlled study of approximately 13,000 women aged 65-74 years diagnosed with invasive breast cancer found that eating raw or cooked carrots and spinach more than twice weekly reduced the risk of breast cancer by 44%, compared with no intake. Longnecker, M. P. et al., “Intake of Carrots, Spinach, and Supplements Containing Vitamin A in Relation to Risk of Breast Cancer,”
Cancer Epid. Biomarkers Prev.
6:887-92 (1997).
As previously indicated, the typical westernized diet, specifically the North American diet, is significantly lacking in beneficial phytochemicals, typically found in many fruits and vegetables, due to inadequate consumpti
Davies Audra
Dykhouse Robin
Groh David
Rehnborg Carl S.
Siddiqui Idrees
Access Business Group International LLC
Evans Charesse
Finnegan Henderson Farabow Garrett & Dunner LLP
Page Thurman K.
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