Dyslipidemias, Hypercholesterolemia, Hyperlipidemias
Conditions
Brief summary
Efficacy of plant stanols as esters on LDL-cholesterol reduction is well documented. LDL-cholesterol lowering efficacy of the ingredient in a biscuit (providing 2 g plant stanols as esters per day) is less well known.
Interventions
DIETARY_SUPPLEMENTPlant stanol ester
DIETARY_SUPPLEMENTPlacebo
Sponsors
Mahidol University
Raisio Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change (proportional) in LDL-c from baseline after 4-weeks' plant stanol ester biscuit consumption compared to controls | 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 | 4 weeks |
Countries
Thailand
Outcome results
None listed