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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05064644
Other study ID # NGH1
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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