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Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans

This study has been completed.
Sponsor:
Collaborator:
WhiteWave Foods, Inc.
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00924391
First received: June 16, 2009
Last updated: June 17, 2009
Last verified: June 2009

June 16, 2009
June 17, 2009
September 2007
December 2007   (final data collection date for primary outcome measure)
cholesterol [ Time Frame: 30 days ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00924391 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans
Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans Study 1

It is becoming increasingly clear that North Americans prefer dietary approaches to enhance health in favour of pharmaceutical approaches. Although the consumption of various phytosterol (PS)-enriched foods have been shown to be effective in lowering plasma cholesterol in a variety of food matrices, the lipid-lowering potential of PS-enriched soymilk has not been investigated. Therefore, the objective of this investigation was to examine the lipid-lowering efficacy of a PS-enriched soymilk beverage in comparison to a 1% dairy milk control. Twenty-three hypercholesterolemic subjects (Total-cholesterol and LDL-cholesterol ≥ 5.0 and 3.5 mmol/L, respectively) consumed 3 tetrapacs per day of a phytosterol-enriched soy beverage providing 1.95g PS/d or a 1% dairy milk control. The study was conducted as a 28 d controlled dietary intervention according to a completely randomized, two-period cross-over design.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Coronary Heart Disease
  • Dietary Supplement: phytosterol enhanced soy based beverage
  • Dietary Supplement: 1% milk
  • Active Comparator: dairy milk
    Control phase with 1% milk.
    Intervention: Dietary Supplement: 1% milk
  • Experimental: phytosterol enhanced soy based beverage
    Treatment phase where control-phase diets are provided with phytosterol enhanced soy based beverage.
    Intervention: Dietary Supplement: phytosterol enhanced soy based beverage
Rideout TC, Chan YM, Harding SV, Jones PJ. Low and moderate-fat plant sterol fortified soymilk in modulation of plasma lipids and cholesterol kinetics in subjects with normal to high cholesterol concentrations: report on two randomized crossover studies. Lipids Health Dis. 2009 Oct 20;8:45.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
August 2008
December 2007   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Healthy males and females, aged 19-60 yr, will be screened for determination of fasting circulating LDL-cholesterol and TG levels.
  2. Subjects accepted into the study will have plasma LDL-C 130-200 mg/dl, TG levels below 250 mg/dl.
  3. The inclusion for body mass index (BMI) range will be 22 to 32 kg/m2.
  4. Subjects must also demonstrate an ability to understand dietary procedures and exercise procedures and be judged as compliant and motivated by the investigators.
  5. Subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study.

Exclusion Criteria:

  1. History of recent (i.e. less than 3 months) or chronic use of oral hypolipidemic therapy, including fish oils, or probucol within the last 6 months.
  2. History of chronic use of alcohol (> 2 drinks/day), systemic antibodies, corticosteroids, androgens, or phenytoin.
  3. Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
  4. Recent onset of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, diabetes, or significant current (ie. onset within past three months) gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year).
  5. Exercise greater than 15 miles/wk or 4,000 kcal/wk.
Both
19 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00924391
WWB2007:110
Yes
Peter JH Jones, Richardson Centre for Functional Foods and Nutraceuticals
University of Manitoba
WhiteWave Foods, Inc.
Principal Investigator: Peter JH Jones, B.ScM.ScPh.D Richardson Centre for Functional Foods and Nutraceuticals
University of Manitoba
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP