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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Hypercholesterolemia
• Intervention / Treatment: Other: Placebo; Other: Plant stanol ester

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

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• 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 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
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Active Comparator; Products that contain plant stanol ester. Product with active ingredient	Other: Plant stanol ester; Product with active ingredient vs product without active ingredient
PLACEBO_COMPARATOR: Placebo comparator; Placebo product. Product without active ingredient	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in low-density lipoprotein (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
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
High density lipoprotein (HDL) cholesterol concentration	Changes in serum HDL cholesterol concentration during the intervention	0 vs 3 weeks
Nuclear magnetic resonance (NMR) blood biomarkers	Changes in specific NMR blood biomarkers	0 vs 3 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2021
• Primary Completion (ACTUAL): November 30, 2021
• Study Completion (ANTICIPATED): December 30, 2021

Study Registration Dates

• First Submitted: November 9, 2021
• First Submitted That Met QC Criteria: November 17, 2021
• First Posted (ACTUAL): November 18, 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: NGH2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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