Soybean Based Diets and CVD Risk Factors

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00175097
• Other study ID #: HL 58008-1785
• Secondary ID: R01HL058008
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: November 26, 2014
• Start date: June 2001
• Est. completion date: May 2005

Study information

• Verified date: November 2014
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: May 2005
• Est. primary completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

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.
• 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.
• 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.
• 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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tufts University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase		24 weeks	No
Primary	Vascular endothelial function; end of each dietary phase		24 weeks	No
Primary	Susceptibility of LDL to oxidation; end of each dietary phase		24 weeks	No
Primary	C-reactive protein; end of each dietary phase		24 weeks	No
Secondary	Endogenous cholesterol synthesis; end of each dietary phase		24 weeks	No
Secondary	Endogenous triglyceride synthesis; end of each dietary phase		24 weeks	No
Secondary	Plasma and Urinary Isoflavone levels; end of each dietary phase		24 weeks	No
Secondary	Genotyping of candidate genes involved in the variability observed in response to dietary modification		24 weeks	No