Hypercholesterolemia
Conditions
Brief summary
The aim is to determine the effect of investigational products on serum LDL cholesterol.
Interventions
OTHERPlant stanol ester
Product with active ingredient vs product without active ingredient
OTHERPlacebo
Placebo
Sponsors
Raisio Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Signed written informed consent * Mildly or moderately elevated plasma cholesterol levels (plasma total cholesterol 5.5-8.0 mmol/l) * Plasma triglyceride levels ≤ 4.0 mmol/l * Age 18-65 years
Exclusion criteria
* Intolerance to oats or other ingredients of the test products * Severe obesity (BMI ≥ 32 kg/m2) * Consumption of lipid/cholesterol lowering medication (e.g. ezetimibe, PCSK9 inhibitors, resins, fibrates) 1 month prior to the screening visit and throughout the study. Statin treatment is allowed at stable dose. * Consumption of plant stanol or plant sterol containing food products or supplements or other foods or supplements such as beta-glucan enriched foods, red rice, berberine or any combination of these used for cholesterol lowering purpose 1 month prior the study entry (baseline blood sample) * History of malignant diseases like cancer within five years prior to recruitment * History of unstable coronary artery disease (myocardial infarction, coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA) within the previous 6 months * Diagnosed type 1 or type 2 diabetes requiring medical treatment * Celiac disease * Medically prescribed diet/treatment for slimming or a special diet like very low calorie diet or use of prescribed an obesity drug (e.g. Orlistat, Victoza) * Alcohol abuse (\> 4 portion/per day) or recreational drug abuse * Pregnancy or planned pregnancy or lactating * Clinically significant abnormalities in screening labs * Participation in another clinical trial in the preceding 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in low-density lipoprotein (LDL) cholesterol concentration (%) | 0 vs 3 weeks | Mean relative change in serum LDL cholesterol concentration during the intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| total cholesterol concentration | 0 vs 3 weeks | Changes in serum total cholesterol concentration during the intervention |
| High density lipoprotein (HDL) cholesterol concentration | 0 vs 3 weeks | Changes in serum HDL cholesterol concentration during the intervention |
| LDL cholesterol concentration | 0 vs 3 weeks | Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group |
| Total triglyceride concentration | 0 vs 3 weeks | Changes in serum triglycerides concentrations |
| Nuclear magnetic resonance (NMR) blood biomarkers | 0 vs 3 weeks | Changes in specific NMR blood biomarkers |
| non-HDL cholesterol concentration | 0 vs 3 weeks | Changes in serum non-HDL cholesterol concentration during the intervention |
Countries
Finland
Outcome results
None listed