Soybean Based Diets and CVD Risk Factors - Full Text View

Purpose

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	Intervention
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


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol

Genetic and Rare Diseases Information Center resources: Sphingolipidosis

U.S. FDA Resources

Further study details as provided by Tufts University:

Primary Outcome Measures:

Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Vascular endothelial function; end of each dietary phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Susceptibility of LDL to oxidation; end of each dietary phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
C-reactive protein; end of each dietary phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Endogenous cholesterol synthesis; end of each dietary phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Endogenous triglyceride synthesis; end of each dietary phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Plasma and Urinary Isoflavone levels; end of each dietary phase [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Genotyping of candidate genes involved in the variability observed in response to dietary modification [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]


Enrollment:	30
Study Start Date:	June 2001
Study Completion Date:	May 2005
Primary Completion Date:	May 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.
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.
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.
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.

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.

Eligibility


Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00175097

Locations


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

Sponsors and Collaborators

Tufts University

Investigators


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

More Information

No publications provided


Responsible Party:	Tufts University
ClinicalTrials.gov Identifier:	NCT00175097 History of Changes
Other Study ID Numbers:	HL 58008-1785, R01HL058008
Study First Received:	September 13, 2005
Last Updated:	November 26, 2014
Health Authority:	United States: Institutional Review Board

Keywords provided by Tufts University:


soy protein lipids lipoproteins	apolipoproteins cholesterol endothelial function

Additional relevant MeSH terms:


Hypercholesterolemia Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases

ClinicalTrials.gov processed this record on February 27, 2015