Application of the BRAFO-tiered approach for benefit-risk assessment to case studies on natural foods.

There is evidence that consumption of fish, especially oily fish, has substantial beneficial effects on health. In particular an inverse relationship of oily fish intake to coronary heart disease incidence has been established. These beneficial effects are ascribed to fish oil components including long chain ω-3 polyunsaturated fatty acids.

A daily intake of approximately 6 microg vitamin B-12 appears to saturate all the vitamin B-12-related variables in Danish postmenopausal women.

Background: Recommended daily intakes of vitamin B-12 vary between 2 and 6 microg.

Objective: The objective was to examine the associations between vitamin B-12 intake and markers of vitamin B-12 deficiency.

Design: We studied 98 Danish postmenopausal women aged 41-75 y.

Soymilk or progesterone for prevention of bone loss--a 2 year randomized, placebo-controlled trial.

Background: Given concerns over the use of hormone replacement therapy (HRT), women are seeking natural alternatives to cope with the symptoms and effects of menopause. The bone sparing effects of soy protein and its isoflavones is well established in animal studies, while 5 previous human studies on soy and bone have yielded variable outcomes due in part to their short duration of study. Progesterone has been suggested as a bone-trophic hormone, but the effect of long-term, low dose transdermal progesterone is unknown.

Dietary phytoestrogens and their effect on bone: evidence from in vitro and in vivo, human observational, and dietary intervention studies.

Impressive data from the many studies on cultured bone cells and rat models of postmenopausal osteoporosis support a significant bone-sparing effect of the soy isoflavones genistein and daidzein. Translating this research to the clinic has been more challenging, and thus far only a few clinical studies have attempted to tease out the influence of phytoestrogens on bone from the many other components of the diet. Human studies have shown promising although variable results.

The clinical importance of the metabolite equol-a clue to the effectiveness of soy and its isoflavones.

Equol [7-hydroxy-3-(4'-hydroxyphenyl)-chroman] is a nonsteroidal estrogen of the isoflavone class. It is exclusively a product of intestinal bacterial metabolism of dietary isoflavones and it possesses estrogenic activity, having affinity for both estrogen receptors, ERalpha and ERbeta. Equol is superior to all other isoflavones in its antioxidant activity.