Clinical trial NCT00175097: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hypercholesterolemia
Keywords: soy protein
lipids
lipoproteins
apolipoproteins
cholesterol
endothelial function
Lead sponsor: Tufts University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 30
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase
timeFrame: 24 weeks
measure: Vascular endothelial function; end of each dietary phase
timeFrame: 24 weeks
measure: Susceptibility of LDL to oxidation; end of each dietary phase
timeFrame: 24 weeks
measure: C-reactive protein; end of each dietary phase
timeFrame: 24 weeks
Secondary outcomes:
measure: Endogenous cholesterol synthesis; end of each dietary phase
timeFrame: 24 weeks
measure: Endogenous triglyceride synthesis; end of each dietary phase
timeFrame: 24 weeks
measure: Plasma and Urinary Isoflavone levels; end of each dietary phase
timeFrame: 24 weeks
measure: Genotyping of candidate genes involved in the variability observed in response to dietary modification
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine
state: Massachusetts
city: Boston
country: United States
facility: Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University
state: Massachusetts
Study officials:
affiliation: Tufts University (HNRCA)
name: Alice H Lichtenstein, DSc
role: PRINCIPAL_INVESTIGATOR
References: