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

Phase 1

Completed

• Conditions: Hypercholesterolemia
• Interventions: Dietary Supplement: control dairy milk; Dietary Supplement: plant sterol enriched soymilk

• Registration Number: NCT00923403
• Lead Sponsor: University of Manitoba

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2008-12
• Study Completion: 2009-01
• Status Verified: 2009-06
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-17
• Last Update Submitted: 2009-06-17
• Study First Posted: 2009-06-18
• Last Update Posted: 2009-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo Comparator	control dairy milk	control dairy milk
experimental	plant sterol enriched soymilk	plant sterol enriched soymilk

Primary Outcome Measures

Name	Time	Method
plasma cholesterol	30 days

Trial Locations

Locations (1)

Richardson Centre for Functional Foods and Nutraceuticals; 🇨🇦 Winnipeg, Manitoba, Canada