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Soy Nuts and Cardiovascular Risk in Postmenopausal Women

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ClinicalTrials.gov Identifier: NCT01740076
Recruitment Status : Completed
First Posted : December 4, 2012
Last Update Posted : March 31, 2017
Sponsor:
Information provided by (Responsible Party):
Francine K. Welty, Beth Israel Deaconess Medical Center

Brief Summary:
To determine the effect of a whole soy food, dietary soy nuts, on blood pressure, lipid levels, inflammation and menopausal symptoms in postmenopausal women.

Condition or disease Intervention/treatment Phase
Postmenopausal Women Other: soy nuts Not Applicable

Detailed Description:
The present study examines the effect of a whole soy food, soy nuts (dry roasted soybeans), added to the Therapeutic Lifestyle Change diet on blood pressure, lipids, inflammation and menopausal symptoms in postmenopausal hypertensive and normotensive women in a randomized crossover trial during an 8-week period. We sought to determine whether dietary soy had an additional benefit to the currently recommended heart healthy diet.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Soy Nuts on Blood Pressure, Lipids and Inflammation in Postmenopausal Women
Study Start Date : September 2001
Actual Primary Completion Date : July 2004
Actual Study Completion Date : November 2012

Arm Intervention/treatment
Experimental: soy nuts
25 g of soy nuts provided daily to the subjects and they were counseled to replace 25 g of protein in their therapeutic lifestyle change (TLC) diet with the soy. TLC diet consisted of 30% of energy from total fat (<7% saturated fat, 12% monounsaturated fat and 11% polyunsaturated fat), 15% from protein and 55% from carbohydrate; less than 200 mg of cholesterol per day and 1200 mg of calcium and 2 fatty fish meals per week. Those ingesting suboptimal dietary calcium were given calcium carbonate supplementation.
Other: soy nuts
Therapeutic lifestyle change diet
Counseling on therapeutic lifestyle change diet consisting of 30% of energy from total fat (<7% saturated fat, 12% monounsaturated fat and 11% polyunsaturated fat), 15% from protein and 55% from carbohydrate; less than 200 mg of cholesterol per day and 1200 mg of calcium and 2 fatty fish meals per week. Those ingesting suboptimal dietary calcium were given calcium carbonate supplementation.
Other: soy nuts



Primary Outcome Measures :
  1. Blood pressure [ Time Frame: 8 weeks ]
    stratified by hypertensive status (normal BP, prehypertension, hypertension)


Secondary Outcome Measures :
  1. lipid levels [ Time Frame: 8 weeks ]
    stratified by hypertension status (normotensive or hypertensive)

  2. inflammatory markers [ Time Frame: 8 weeks ]
    stratified by hypertensive status (normotensive or hypertensive)

  3. menopausal symptoms [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women with absence of menses for at least 12 months or irregular periods and hot flashes.

Exclusion Criteria:

  • were current cigarette smoking or smoking in the previous year;
  • clinical coronary artery disease, peripheral artery disease, or cerebrovascular disease;
  • known diabetes mellitus or a fasting glucose level of 126 mg/dL or greater;
  • a history of breast cancer; a fasting triglyceride level greater than 400 mg/dL; systolic BP of 165 mm Hg or greater or diastolic BP of 100 mm Hg or greater;
  • untreated hypothyroidism; systemic or endocrine disease known to affect lipid, mineral, or bone metabolism;
  • and consumption of more than 21 alcoholic drinks per week.
  • Use of lipid-lowering drugs, hormone therapy, medications for osteoporosis, and soy products was discontinued for 2 months before entering the study. Participants took a multivitamin but no additional vitamin or mineral supplements or other soy products during the study.

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 ClinicalTrials.gov identifier (NCT number): NCT01740076


Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Investigators
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Principal Investigator: Francine Welty, MD, PhD Beth Israel Deaconess Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Francine K. Welty, Associate Professor of Medicine, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT01740076    
Other Study ID Numbers: 2001P001604
First Posted: December 4, 2012    Key Record Dates
Last Update Posted: March 31, 2017
Last Verified: March 2017
Keywords provided by Francine K. Welty, Beth Israel Deaconess Medical Center:
isoflavones, hypertension, soy, diet, nutrition, women, inflammation, hot flashes