Back to resultsSoybean Based Diets and CVD Risk Factors
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diet: soybeans and products made thereof
Diet: soybean flour and products made thereof
Diet: soybean milk
Diet: Animal protein based diet
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring soy protein, lipids, lipoproteins, apolipoproteins, cholesterol, endothelial function
Eligibility 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.
Sites / Locations
- Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine
- Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Other
Other
Other
Other
Arm Label
soybeans and products made thereof
soybean flour and products made thereof
soybean milk
animal protein based diet
Arm Description
Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes & grits)
Diet: soybean flour and products made thereof (textured soybean)
Diet: soybean milk (tofu, soybean yogurt, cheese, etc.)
Diet: animal protein based diet
Outcomes
Primary Outcome Measures
Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase
Vascular endothelial function; end of each dietary phase
Susceptibility of LDL to oxidation; end of each dietary phase
C-reactive protein; end of each dietary phase
Secondary Outcome Measures
Endogenous cholesterol synthesis; end of each dietary phase
Endogenous triglyceride synthesis; end of each dietary phase
Plasma and Urinary Isoflavone levels; end of each dietary phase
Genotyping of candidate genes involved in the variability observed in response to dietary modification
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00175097
Brief Title
Soybean Based Diets and CVD Risk Factors
Official Title
Impact of Different Forms of Soybean Based Foods on Cardiovascular Disease Risk Factors in Hypercholesterolemic Subjects.
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Completed
Study Start Date
June 2001 (undefined)
Primary Completion Date
May 2005 (Actual)
Study Completion Date
May 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
soy protein, lipids, lipoproteins, apolipoproteins, cholesterol, endothelial function
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
soybeans and products made thereof
Arm Type
Other
Arm Description
Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes & grits)
Arm Title
soybean flour and products made thereof
Arm Type
Other
Arm Description
Diet: soybean flour and products made thereof (textured soybean)
Arm Title
soybean milk
Arm Type
Other
Arm Description
Diet: soybean milk (tofu, soybean yogurt, cheese, etc.)
Arm Title
animal protein based diet
Arm Type
Other
Arm Description
Diet: animal protein based diet
Intervention Type
Other
Intervention Name(s)
Diet: soybeans and products made thereof
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diet: soybean flour and products made thereof
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diet: soybean milk
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Diet: Animal protein based diet
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase
Time Frame
24 weeks
Title
Vascular endothelial function; end of each dietary phase
Time Frame
24 weeks
Title
Susceptibility of LDL to oxidation; end of each dietary phase
Time Frame
24 weeks
Title
C-reactive protein; end of each dietary phase
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Endogenous cholesterol synthesis; end of each dietary phase
Time Frame
24 weeks
Title
Endogenous triglyceride synthesis; end of each dietary phase
Time Frame
24 weeks
Title
Plasma and Urinary Isoflavone levels; end of each dietary phase
Time Frame
24 weeks
Title
Genotyping of candidate genes involved in the variability observed in response to dietary modification
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alice H Lichtenstein, DSc
Organizational Affiliation
Tufts University (HNRCA)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Soybean Based Diets and CVD Risk Factors
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