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

Hypercholesterolemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05064644
• Other study ID #: NGH1
• Status: Completed
• Phase: N/A
• Start date: August 1, 2021
• Est. completion date: November 30, 2021

Study information

• Verified date: December 2021
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: November 30, 2021
• Est. primary completion date: October 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Other:
• Product that contains plant stanol ester
Product with active ingredient
• Placebo product
Product without active ingredient

Locations

Country	Name	City	State
Finland	Nightingale Health plc	Helsinki

Sponsors (1)

Lead Sponsor	Collaborator
Raisio Group

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in LDL cholesterol concentration (%)	Mean relative change in serum LDL cholesterol concentration during the intervention	0 vs 3 weeks
Secondary	LDL cholesterol concentration	Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group	0 vs 3 weeks
Secondary	total cholesterol concentration	Changes in serum total cholesterol concentration during the intervention	0 vs 3 weeks
Secondary	HDL cholesterol concentration	Changes in serum HDL cholesterol concentration during the intervention	0 vs 3 weeks
Secondary	non-HDL cholesterol concentration	Changes in serum non-HDL cholesterol concentration during the intervention	0 vs 3 weeks
Secondary	Total triglyceride concentration	Changes in serum triglycerides concentrations	0 vs 3 weeks
Secondary	NMR blood biomarkers	Changes in specific NMR blood biomarkers	0 vs 3 weeks