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
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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 |
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 |
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.
|
- Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase [ Time Frame: 24 weeks ]
- Vascular endothelial function; end of each dietary phase [ Time Frame: 24 weeks ]
- Susceptibility of LDL to oxidation; end of each dietary phase [ Time Frame: 24 weeks ]
- C-reactive protein; end of each dietary phase [ Time Frame: 24 weeks ]
- Endogenous cholesterol synthesis; end of each dietary phase [ Time Frame: 24 weeks ]
- Endogenous triglyceride synthesis; end of each dietary phase [ Time Frame: 24 weeks ]
- Plasma and Urinary Isoflavone levels; end of each dietary phase [ Time Frame: 24 weeks ]
- Genotyping of candidate genes involved in the variability observed in response to dietary modification [ Time Frame: 24 weeks ]

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Ages Eligible for Study: | 50 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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