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Efficacy of Sterol-Fortified Low Fat Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans - Study II

NCT00923403 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 33

Last updated 2009-06-18

No results posted yet for this study

Summary

Hypercholesterolemia is a well-established risk factor for the development of atherosclerosis, a component of cardiovascular disease (CVD). The National Cholesterol Education Program advises the public to consume 2 g/day of plant sterols or stanols in addition to the Therapeutic Lifestyle Change Diet to lower elevated low-density lipoprotein (LDL) cholesterol levels. For foods to carry the FDA health claim label they must contain 0.65 g of phytosterol ester or 1.7 g of phytostanol ester per serving. The study was a controlled diet, cross-over clinical investigation using a Latin square sequence. It consisted of two 29 d phases separated by a four week wash out interval. Subjects were randomized to one of two treatment arms: 1 % dairy milk or low-fat soy beverage providing 1.95 g plant sterols/day.

Conditions

Interventions

DIETARY_SUPPLEMENT

plant sterol enriched soymilk

plant sterol enriched soymilk

DIETARY_SUPPLEMENT

control dairy milk

control dairy milk

Sponsors & Collaborators

  • WhiteWave Foods, Inc.

    collaborator INDUSTRY

  • University of Manitoba

    lead OTHER

Principal Investigators

  • Peter JH Jones, PHD · Richardson Centre for Functional Foods and Nutraceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2008-12-31
Completion
2009-01-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00923403 on ClinicalTrials.gov