Soybean Based Diets and CVD Risk Factors

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT00175097
First received: September 13, 2005
Last updated: November 26, 2014
Last verified: November 2014
  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:


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 July 05, 2015