Lipid Lowering Effect of Plant Stanol Ester in a Spoonable Non-dairy Product

Not Applicable

Completed

• Conditions: Hypercholesterolemia

• Registration Number: NCT05064644
• Lead Sponsor: Raisio Group

Brief Summary

The aim is to determine the effect of investigational products on serum LDL cholesterol.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-01
• Study First Submitted: 2021-09-10
• Study First Submitted QC: 2021-09-21
• Study First Posted: 2021-10-01
• Primary Completion: 2021-10-30
• Study Completion: 2021-11-30
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-02
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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 such as Benecol, Becel pro.active, Keiju Alentaja 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in LDL cholesterol concentration (%)	0 vs 3 weeks	Mean relative change in serum LDL cholesterol concentration during the intervention

Secondary Outcome Measures

Name	Time	Method
LDL cholesterol concentration	0 vs 3 weeks	Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group
total cholesterol concentration	0 vs 3 weeks	Changes in serum total cholesterol concentration during the intervention
HDL cholesterol concentration	0 vs 3 weeks	Changes in serum HDL cholesterol concentration during the intervention
Total triglyceride concentration	0 vs 3 weeks	Changes in serum triglycerides concentrations
non-HDL cholesterol concentration	0 vs 3 weeks	Changes in serum non-HDL cholesterol concentration during the intervention
NMR blood biomarkers	0 vs 3 weeks	Changes in specific NMR blood biomarkers

Trial Locations

Locations (1)

Nightingale Health plc; 🇫🇮 Helsinki, Finland