Soybean Based Diets and CVD Risk Factors

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

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.

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
    • Boston, Massachusetts, United States, 02111
      • Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Tufts University
• Investigators: Principal Investigator: Alice H Lichtenstein, DSc, Tufts University (HNRCA)

Study record dates

Study Major Dates

• Study Start: June 1, 2001
• Primary Completion (Actual): May 1, 2005
• Study Completion (Actual): May 1, 2005

Study Registration Dates

• First Submitted: September 13, 2005
• First Submitted That Met QC Criteria: September 13, 2005
• First Posted (Estimate): September 15, 2005

Study Record Updates

• Last Update Posted (Estimate): December 2, 2014
• Last Update Submitted That Met QC Criteria: November 26, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: lipids; lipoproteins; soy protein; endothelial function; cholesterol; apolipoproteins
• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: HL 58008-1785; R01HL058008 (U.S. NIH Grant/Contract)