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Soybean Based Diets and CVD Risk Factors

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ClinicalTrials.gov Identifier: NCT00175097
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : December 2, 2014
Sponsor:
Information provided by (Responsible Party):
Tufts University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : June 2001
Actual Primary Completion Date : May 2005
Actual Study Completion Date : May 2005

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Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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Primary Outcome Measures :
  1. Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase [ Time Frame: 24 weeks ]
  2. Vascular endothelial function; end of each dietary phase [ Time Frame: 24 weeks ]
  3. Susceptibility of LDL to oxidation; end of each dietary phase [ Time Frame: 24 weeks ]
  4. C-reactive protein; end of each dietary phase [ Time Frame: 24 weeks ]

Secondary Outcome Measures :
  1. Endogenous cholesterol synthesis; end of each dietary phase [ Time Frame: 24 weeks ]
  2. Endogenous triglyceride synthesis; end of each dietary phase [ Time Frame: 24 weeks ]
  3. Plasma and Urinary Isoflavone levels; end of each dietary phase [ Time Frame: 24 weeks ]
  4. Genotyping of candidate genes involved in the variability observed in response to dietary modification [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT00175097     History of Changes
Other Study ID Numbers: HL 58008-1785
R01HL058008 ( U.S. NIH Grant/Contract )
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: December 2, 2014
Last Verified: November 2014

Keywords provided by Tufts University:
soy protein
lipids
lipoproteins
 apolipoproteins
cholesterol
endothelial function

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases