NCT00175097

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2001

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2001

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 15, 2005

Completed
Last Updated

December 2, 2014

Status Verified

November 1, 2014

Enrollment Period

3.9 years

First QC Date

September 13, 2005

Last Update Submit

November 26, 2014

Conditions

Hypercholesterolemia

Keywords

soy proteinlipidslipoproteinsapolipoproteinscholesterolendothelial function

Outcome Measures

Primary Outcomes (4)

  • Fasting and non-fasting plasma lipids, apolipoproteins; end of each dietary phase

    24 weeks

  • Vascular endothelial function; end of each dietary phase

    24 weeks

  • Susceptibility of LDL to oxidation; end of each dietary phase

    24 weeks

  • C-reactive protein; end of each dietary phase

    24 weeks

Secondary Outcomes (4)

  • Endogenous cholesterol synthesis; end of each dietary phase

    24 weeks

  • Endogenous triglyceride synthesis; end of each dietary phase

    24 weeks

  • Plasma and Urinary Isoflavone levels; end of each dietary phase

    24 weeks

  • Genotyping of candidate genes involved in the variability observed in response to dietary modification

    24 weeks

Study Arms (4)

soybeans and products made thereof

OTHER

Diet: soybeans and products made thereof (soynuts, soynut butter, soy flakes \& grits)

Other: Diet: soybeans and products made thereof

soybean flour and products made thereof

OTHER

Diet: soybean flour and products made thereof (textured soybean)

Other: Diet: soybean flour and products made thereof

soybean milk

OTHER

Diet: soybean milk (tofu, soybean yogurt, cheese, etc.)

Other: Diet: soybean milk

animal protein based diet

OTHER

Diet: animal protein based diet

Other: Diet: Animal protein based diet

Interventions

Diet: soybeans and products made thereofOTHER

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.

soybeans and products made thereof
Diet: soybean flour and products made thereofOTHER

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 flour and products made thereof
Diet: soybean milkOTHER

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.

soybean milk
Diet: Animal protein based dietOTHER

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.

animal protein based diet

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Soy allergy, Smokers, Consuming \>2 alcoholic drinks per day, Pre-menopausal women.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Cardiology, Tufts-New England Medical Center Hospitals, Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Jean Mayer USDA Human Nutrition Research Center on Aging at Tufts University

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Alice H Lichtenstein, DSc

    Tufts University (HNRCA)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 15, 2005

Study Start

June 1, 2001

Primary Completion

May 1, 2005

Study Completion

May 1, 2005

Last Updated

December 2, 2014

Record last verified: 2014-11

Locations

US(2)