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

This study has been completed.
Sponsor:
Collaborator:
WhiteWave Foods, Inc.
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00923403
First received: June 16, 2009
Last updated: June 17, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention Phase
Hypercholesterolemia
Dietary Supplement: plant sterol enriched soymilk
Dietary Supplement: control dairy milk
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Sterol-Fortified Low Fat Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans - Study II

Resource links provided by NLM:


Further study details as provided by University of Manitoba:

Primary Outcome Measures:
  • plasma cholesterol [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Enrollment: 33
Study Start Date: August 2008
Study Completion Date: January 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Comparator
control dairy milk
Dietary Supplement: control dairy milk
control dairy milk
Experimental: experimental
plant sterol enriched soymilk
Dietary Supplement: plant sterol enriched soymilk
plant sterol enriched soymilk

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy males and females, age 19-60 years old, will be screened for determination of fasting circulating LDL-cholesterol and triglyceride (TG) levels.
  2. Subjects accepted into the study will have plasma LDL-C levels between 120 and 200 mg/dl, TG levels below 250 mg/dl, and a body mass index (BMI) between 22 to 32 kg/m2.
  3. Subjects must also demonstrate an ability to understand dietary and exercise procedures and be judged as compliant and motivated by the investigators.
  4. 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 mo) 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/d), 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 walking or running 15 miles/wk or 4,000 kcal/week.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00923403

Locations
Canada, Manitoba
Richardson Centre for Functional Foods and Nutraceuticals
Winnipeg, Manitoba, Canada, R3T 6C5
Sponsors and Collaborators
University of Manitoba
WhiteWave Foods, Inc.
Investigators
Principal Investigator: Peter JH Jones, PHD Richardson Centre for Functional Foods and Nutraceuticals
  More Information

No publications provided by University of Manitoba

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Peter JH Jones, Richardson Centre for Functional Foods and Nutraceuticals, University of Manitoba
ClinicalTrials.gov Identifier: NCT00923403     History of Changes
Other Study ID Numbers: 555-210
Study First Received: June 16, 2009
Last Updated: June 17, 2009
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Manitoba:
plant sterols
diet
soymilk
cholesterol

Additional relevant MeSH terms:
Hypercholesterolemia
Inflammation
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 17, 2014