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

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

Study Description
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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
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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

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. cholesterol [ Time Frame: 30 days ]

Eligibility Criteria
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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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924391


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

Responsible Party: Peter JH Jones, Richardson Centre for Functional Foods and Nutraceuticals
ClinicalTrials.gov Identifier: NCT00924391     History of Changes
Other Study ID Numbers: WWB2007:110
First Posted: June 18, 2009    Key Record Dates
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:
Inflammation
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
 Pathologic Processes
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases