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

• ClinicalTrials.gov Identifier: NCT00924391
• Recruitment Status: Completed
• First Posted: June 18, 2009
• Last Update Posted: June 18, 2009
• Sponsor: University of Manitoba
• Collaborator: WhiteWave Foods, Inc.
• Information provided by: University of Manitoba

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Coronary Heart Disease	Dietary Supplement: phytosterol enhanced soy based beverage; Dietary Supplement: 1% milk	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Efficacy of Sterol Enhanced Soy Beverage on Cholesterol Metabolism, Inflammation and Oxidative Status in Humans Study 1
• Study Start Date: September 2007
• Actual Primary Completion Date: December 2007
• Actual Study Completion Date: August 2008

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. cholesterol [ Time Frame: 30 days ]

Eligibility Criteria

• Ages Eligible for Study: 19 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Canada, Manitoba

Richardson Centre for Functional Foods and Nutraceuticals

Winnipeg, Manitoba, Canada, R3T 2N2

Sponsors and Collaborators

University of Manitoba

WhiteWave Foods, Inc.

Investigators

• Principal Investigator: Peter JH Jones, B.ScM.ScPh.D; Richardson Centre for Functional Foods and Nutraceuticals

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Peter JH Jones, Richardson Centre for Functional Foods and Nutraceuticals
• ClinicalTrials.gov Identifier: NCT00924391
• Other Study ID Numbers: WWB2007:110
• First Posted: June 18, 2009
• Last Update Posted: June 18, 2009
• Last Verified: June 2009

Keywords provided by University of Manitoba:

cholesterol; plant sterols; cholesterol absorption

Additional relevant MeSH terms:

Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Inflammation; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases