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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.
 
ClinicalTrials.gov Identifier: NCT00241735
Recruitment Status : Completed
First Posted : October 19, 2005
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Vanderbilt University Medical Center

Tracking Information
First Submitted Date October 17, 2005
First Posted Date October 19, 2005
Last Update Posted Date September 14, 2017
Study Start Date September 2005
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Soy Food and Coronary Heart Disease in Women
Official Title Not Provided
Brief Summary To investigate whether soy food intake reduces risk of non-fatal myocardial infarction (MI) and fatal coronary heart disease in Chinese women.
Detailed Description

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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Not Provided
Condition
  • Cardiovascular Diseases
  • Coronary Disease
  • Heart Diseases
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September¬†13,¬†2017)
135896
Original Enrollment Not Provided
Actual Study Completion Date May 2009
Actual Primary Completion Date May 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria Not Provided
Sex/Gender
Sexes Eligible for Study: Female
Ages up to 100 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00241735
Other Study ID Numbers 1311
R01HL079123 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Vanderbilt University Medical Center
Study Sponsor Vanderbilt University Medical Center
Collaborators National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Xiao Shu Vanderbilt University Medical Center
PRS Account Vanderbilt University Medical Center
Verification Date September 2017