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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02331043 |
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Date of registration:
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31/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Serum Cholesterol Reduction Efficacy of Biscuit With Plant Stanol Ester
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Scientific title:
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Serum Cholesterol Reduction Efficacy of Biscuit With Added Plant Stanol Ester |
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Date of first enrolment:
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March 2013 |
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Target sample size:
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119 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02331043 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Thailand
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Contacts
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Name:
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Wantanee Kriengsinyos, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mahidol University, Thailand |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- mildly or elevated fasting serum cholesterol levels (between 5.2 to 6.5 mmol/l)
- fasting serum triglyceride levels below 3.0 mmol/l
- normal liver, kidney and thyroid function
- no lipid lowering medication
- no history of unstable coronary artery disease (myocardial infarction, coronary
artery bypass craft (CABG), percutaneous transluminal coronary angioplasty (PTCA)
within the previous 6 months, diabetes, temporal ischemic attack and malignant
diseases
Exclusion Criteria:
- alcohol abuse (> 4 portion/per day)
- pregnancy
- use of plant stanol and plant sterol products and equivalent cholesterol lowering
products, though the ones who have discontinued the consumption of these products
minimum 3 weeks before the beginning of the study, can be included
Age minimum:
20 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hyperlipidemias
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Dyslipidemias
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Hypercholesterolemia
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Intervention(s)
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Dietary Supplement: Placebo
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Dietary Supplement: Plant stanol ester
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Primary Outcome(s)
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Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption in subjects consuming the biscuit with or without a meal
[Time Frame: 4 weeks]
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Secondary ID(s)
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CL 2012_034
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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