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Soybean Based Diets and CVD Risk Factors

NCT ID: NCT00175097

Last Updated: 2014-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-06-30

Study Completion Date

2005-05-31

Brief Summary

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To evaluate the impact of soybean processing as well as the effect of soy relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects.

Detailed Description

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Recent data suggests that the magnitude of the effect of soy protein on lipid and lipoprotein levels is variable and less dramatic than originally reported. This discordance might be attributable to the forms of soy protein used, as well as subtle unrecognized shifts in the fatty acid, cholesterol and fiber content of the diets.The aim of the present investigation is to assess the effects of different forms of soybeans (whole bean and products made thereof), products derived from soy flour (textured soy protein) and products made from a soybean extract (i.e. tofu, yogurt) relative to animal protein, independent of alterations in the fatty acid profile of the diet on CVD risk factors in hypercholesterolemic subjects. The intent is to isolate any potential impact of processing on the plasma lipid lowering efficacy of the soy product or soy protein relative to animal protein.

Conditions

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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soybeans and products made thereof

Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes \& grits)

Group Type OTHER

Diet: soybeans and products made thereof

Intervention Type OTHER

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybeans and products made thereof.

soybean flour and products made thereof

Diet: soybean flour and products made thereof (textured soybean)

Group Type OTHER

Diet: soybean flour and products made thereof

Intervention Type OTHER

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean flour and products made thereof.

soybean milk

Diet: soybean milk (tofu, soybean yogurt, cheese, etc.)

Group Type OTHER

Diet: soybean milk

Intervention Type OTHER

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean milk.

animal protein based diet

Diet: animal protein based diet

Group Type OTHER

Diet: Animal protein based diet

Intervention Type OTHER

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate animal protein.

Interventions

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Diet: soybeans and products made thereof

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybeans and products made thereof.

Intervention Type OTHER

Diet: soybean flour and products made thereof

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean flour and products made thereof.

Intervention Type OTHER

Diet: soybean milk

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate soybean milk.

Intervention Type OTHER

Diet: Animal protein based diet

The macronutrient composition of each diets will be similar. The difference will be the type of protein (animal or soybean) or form of soybean incorporated into various food mixtures. This diet will incorporate animal protein.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Plasma LDL-C \>120mg/dL, Free from chronic illness, Not taking medications known to affect lipid metabolism (lipid lowering drugs, beta-blockers, fish-oil capsules, cis-retinoic acid, ascorbic acid, vitamin E, diuretics or hormones), Post-menopausal women.

Exclusion Criteria

Soy allergy, Smokers, Consuming \>2 alcoholic drinks per day, Pre-menopausal women.
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tufts University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alice H Lichtenstein, DSc

Role: PRINCIPAL_INVESTIGATOR

Tufts University (HNRCA)

Locations

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Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine

Boston, Massachusetts, United States

Site Status

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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R01HL058008

Identifier Type: NIH

Identifier Source: secondary_id

View Link

HL 58008-1785

Identifier Type: -

Identifier Source: org_study_id