Soybean Based Diets and CVD Risk Factors

Sponsor

Tufts University (Other)

Overall Status

Completed

CT.gov ID

NCT00175097

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Other: Diet: soybeans and products made thereof Other: Diet: soybean flour and products made thereof Other: Diet: soybean milk Other: Diet: Animal protein based diet	N/A

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

Official Title:

Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.

Study Start Date :

Jun 1, 2001

Actual Primary Completion Date :

May 1, 2005

Actual Study Completion Date :

May 1, 2005

Arms and Interventions

Arm	Intervention/Treatment
Other: soybeans and products made thereof Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes & grits)	Other: 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.
Other: soybean flour and products made thereof Diet: soybean flour and products made thereof (textured soybean)	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.
Other: soybean milk Diet: soybean milk (tofu, soybean yogurt, cheese, etc.)	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.
Other: animal protein based diet Diet: animal protein based diet	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.

Outcome Measures

Primary Outcome Measures

Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase [24 weeks]
Vascular endothelial function; end of each dietary phase [24 weeks]
Susceptibility of LDL to oxidation; end of each dietary phase [24 weeks]
C-reactive protein; end of each dietary phase [24 weeks]

Secondary Outcome Measures

Endogenous cholesterol synthesis; end of each dietary phase [24 weeks]
Endogenous triglyceride synthesis; end of each dietary phase [24 weeks]
Plasma and Urinary Isoflavone levels; end of each dietary phase [24 weeks]
Genotyping of candidate genes involved in the variability observed in response to dietary modification [24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine	Boston	Massachusetts	United States	02111
2	Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University	Boston	Massachusetts	United States	02111