Soy Nuts and Cardiovascular Risk in Postmenopausal Women

Study Overview
=================
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.

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.

Official Title
-----------------
Effect of Soy Nuts on Blood Pressure, Lipids and Inflammation in Postmenopausal Women

Conditions
-----------------
Postmenopausal Women

Intervention / Treatment
-----------------
* Other: soy nuts


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: soy nuts<br>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<br> <br> |
| Other: Therapeutic lifestyle change diet<br>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<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | stratified by hypertensive status (normal BP, prehypertension, hypertension) | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lipid levels | stratified by hypertension status (normotensive or hypertensive) | 8 weeks | 
| inflammatory markers | stratified by hypertensive status (normotensive or hypertensive) | 8 weeks | 
| menopausal symptoms |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
isoflavones, hypertension, soy, diet, nutrition, women, inflammation, hot flashes