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Soy Food and Coronary Heart Disease in Women

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00241735
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : September 14, 2017
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Brief Summary:
To investigate whether soy food intake reduces risk of non-fatal myocardial infarction (MI) and fatal coronary heart disease in Chinese women.

Condition or disease
Cardiovascular Diseases Coronary Disease Heart Diseases

Detailed Description:


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.


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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Study Type : Observational
Actual Enrollment : 135896 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2005
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00241735

Sponsors and Collaborators
Vanderbilt University Medical Center
National Heart, Lung, and Blood Institute (NHLBI)
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Principal Investigator: Xiao Shu Vanderbilt University Medical Center
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Responsible Party: Vanderbilt University Medical Center Identifier: NCT00241735    
Other Study ID Numbers: 1311
R01HL079123 ( U.S. NIH Grant/Contract )
First Posted: October 19, 2005    Key Record Dates
Last Update Posted: September 14, 2017
Last Verified: September 2017
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Diseases
Coronary Disease
Myocardial Ischemia
Vascular Diseases