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

NCT00924391 | Completed Phase 2 DMC

• 1 other identifier: WWB2007:110
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Coronary Heart Disease

Keywords

cholesterol; plant sterols; cholesterol absorption

Outcome Measures

Primary Outcomes (1)

• cholesterol

  30 days

Study Arms (2)

dairy milk

ACTIVE COMPARATOR

Control phase with 1% milk.

Dietary Supplement: 1% milk

phytosterol enhanced soy based beverage

EXPERIMENTAL

Treatment phase where control-phase diets are provided with phytosterol enhanced soy based beverage.

Dietary Supplement: phytosterol enhanced soy based beverage

Interventions

phytosterol enhanced soy based beverage DIETARY_SUPPLEMENT

phytosterol enhanced soy based beverage

1% milk DIETARY_SUPPLEMENT

dairy milk

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females, aged 19-60 yr, will be screened for determination of fasting circulating LDL-cholesterol and TG levels.
• Subjects accepted into the study will have plasma LDL-C 130-200 mg/dl, TG levels below 250 mg/dl.
• Subjects must also demonstrate an ability to understand dietary procedures and exercise procedures and be judged as compliant and motivated by the investigators.
• 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.

You may not qualify if:

• 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.
• History of chronic use of alcohol (\> 2 drinks/day), systemic antibodies, corticosteroids, androgens, or phenytoin.
• Myocardial infarction, coronary artery bypass, or other major surgical procedures within the last six months.
• 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).
• Exercise greater than 15 miles/wk or 4,000 kcal/wk.

Sponsors & Collaborators

• University of Manitoba: lead
• WhiteWave Foods, Inc.: collaborator

Study Sites (1)

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, R3T 2N2, Canada

Location

Related Publications (1)

• 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.

  PMID: 19843338 DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Milk

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Peter JH Jones, B.ScM.ScPh.D

  Richardson Centre for Functional Foods and Nutraceuticals

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 18, 2009
• Study Start: September 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: August 1, 2008
• Last Updated: June 18, 2009

Record last verified: 2009-06

Locations

CA (1)