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.

Study Overview

• Status: Completed
• Conditions: Coronary Heart Disease
• Intervention / Treatment: Dietary supplement: 1% milk; Dietary supplement: phytosterol enhanced soy based beverage

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3T 2N2
      • Richardson Centre for Functional Foods and Nutraceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: dairy milk; Control phase with 1% milk.	Dietary supplement: 1% milk
Experimental: phytosterol enhanced soy based beverage; Treatment phase where control-phase diets are provided with phytosterol enhanced soy based beverage.	Dietary supplement: phytosterol enhanced soy based beverage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
cholesterol	30 days

Collaborators and Investigators

• Sponsor: University of Manitoba
• Collaborators: WhiteWave Foods, Inc.
• Investigators: Principal Investigator: Peter JH Jones, B.ScM.ScPh.D, Richardson Centre for Functional Foods and Nutraceuticals

Publications and helpful links

General Publications

• 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. doi: 10.1186/1476-511X-8-45.

Study record dates

Study Major Dates

• Study Start: September 1, 2007
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): August 1, 2008

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 17, 2009
• First Posted (Estimate): June 18, 2009

Study Record Updates

• Last Update Posted (Estimate): June 18, 2009
• Last Update Submitted That Met QC Criteria: June 17, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: cholesterol; plant sterols; cholesterol absorption
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Heart Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Inflammation
• Other Study ID Numbers: WWB2007:110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No