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

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.
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Dietary Supplement: phytosterol enhanced soy based beverage |
- cholesterol [ Time Frame: 30 days ]

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Ages Eligible for Study: | 19 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 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.
- The inclusion for body mass index (BMI) range will be 22 to 32 kg/m2.
- 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924391
Canada, Manitoba | |
Richardson Centre for Functional Foods and Nutraceuticals | |
Winnipeg, Manitoba, Canada, R3T 2N2 |
Principal Investigator: | Peter JH Jones, B.ScM.ScPh.D | Richardson Centre for Functional Foods and Nutraceuticals |
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 Key Record Dates |
Last Update Posted: | June 18, 2009 |
Last Verified: | June 2009 |
cholesterol plant sterols cholesterol absorption |
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Inflammation |
Pathologic Processes Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |