Cardiovascular Diseases Clinical Trial
To investigate whether soy food intake reduces risk of non-fatal myocardial infarction (MI) and fatal coronary heart disease in Chinese women.
BACKGROUND:
Coronary heart disease (CHD) is the leading cause of death in the US and many other
countries. Estrogen deficiency plays a significant role in the development of coronary heart
disease (CHD) in postmenopausal women. Recently, a series of randomized clinical trials
evaluating the effects of hormone replacement therapy (HRT) on CHD yielded surprisingly
deleterious results, shifting clinical decision-making from a position of presumed benefit to
one of potential harm. Soy food is emerging as a promising natural substitute for HRT, given
its estrogenic properties and potential lipids benefits. However, data directly linking soy
food intake to the clinical endpoints of CHD are lacking.
DESIGN NARRATIVE:
The study will evaluate the association of soy food consumption with CHD using resources from
the Shanghai Women's Health Study (SWHS), an ongoing prospective cohort study of 75,000
Chinese women who were recruited from 1997 to 2000 and who completed two extensive dietary
assessments at baseline. The investigators will verify all CHD events identified in this
cohort during the follow-up and longitudinally analyze the association between soy food
intake and CHD risk, overall, and according to conventional CHD risk factors. In addition,
they will conduct a nested case-control study to evaluate the association of urinary
isoflavonoids (a biomarker of soy intake) and risk of CHD, and to investigate whether soy and
CHD associations are modified by baseline levels of lipids and plasma C-reactive protein, two
well established risk markers of CHD. In the United States, the sale of soy products has
increased more than 3-fold in recent decades, and the proportion of people reporting soy
product consumption at least once a week nearly doubled in the last six years. However, the
overall intake level of soy food in the US population is still low, and women who consume soy
food regularly are likely to be highly selective. Furthermore, it is difficult, if at all
possible, to assess usual soy food intake in the US population because soy protein is added
to many American food products. Informative studies on the association between soy food
intake and CHD risk are better conducted in Chinese and other Asian populations, where soy
food is part of traditional dietary practice. The SWHS with its wealth of data on dietary and
lifestyle factors and biological samples provides a unique and unparalleled opportunity to
prospectively investigate the effects of soy food intake on the risk of CHD, and to identify
those most likely to benefit from consumption of soy food.
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