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

Lipid Lowering Effect of Plant Stanol Ester in Oat-based, Fermented Spoonable Dairy Analogue -a 3-week Randomized, Double-blind, Placebo-controlled, Parallel-group Intervention Study

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

Study Overview

• Status: Completed
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Other: Product that contains plant stanol ester; Other: Placebo product

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland, 00330
    • Nightingale Health plc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plant stanol ester comparator; Product that contains plant stanol ester	Other: Product that contains plant stanol ester; Product with active ingredient
Placebo Comparator: Placebo comparator; Placebo product	Other: Placebo product; Product without active ingredient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in LDL cholesterol concentration (%)	Mean relative change in serum LDL cholesterol concentration during the intervention	0 vs 3 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Raisio Group
• Investigators: Principal Investigator: Helena Gylling, MD, Helsinki University Hospital, Helsinki, Finland

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Actual): October 30, 2021
• Study Completion (Actual): November 30, 2021

Study Registration Dates

• First Submitted: September 10, 2021
• First Submitted That Met QC Criteria: September 21, 2021
• First Posted (Actual): October 1, 2021

Study Record Updates

• Last Update Posted (Actual): December 3, 2021
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypercholesterolemia
• Other Study ID Numbers: NGH1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No