Soybean Based Diets and CVD Risk Factors

Tufts University

Status: Completed

Conditions: Hypercholesterolemia

Treatments: Other: Diet: soybeans and products made thereof; Other: Diet: Animal protein based diet; Other: Diet: soybean milk; Other: Diet: soybean flour and products made thereof

Study type: Interventional

Funder types: Other

Identifiers

NCT00175097

R01HL058008 (U.S. NIH Grant/Contract)

HL 58008-1785

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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30 participants in 4 patient groups

soybeans and products made thereof

Other group

Description:

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

Treatment:

Other: Diet: soybeans and products made thereof

soybean flour and products made thereof

Other group

Description:

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

Treatment:

Other: Diet: soybean flour and products made thereof

soybean milk

Other group

Description:

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

Treatment:

Other: Diet: soybean milk

animal protein based diet

Other group

Description:

Diet: animal protein based diet

Treatment:

Other: Diet: Animal protein based diet