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

Not Applicable

Completed

• Conditions: Hypercholesterolemia
• Interventions: Other: Product that contains plant stanol ester; Other: Placebo product

• 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

Arm && Interventions

Group	Intervention	Description
Plant stanol ester comparator	Product that contains plant stanol ester	Product that contains plant stanol ester
Placebo comparator	Placebo product	Placebo product

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