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

Sponsor

Raisio Group (Industry)

Overall Status

Active, not recruiting

CT.gov ID

NCT05126056

Collaborator

(none)

Enrollment

Location

Arms

3.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Other: Plant stanol ester Other: Placebo	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

55 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2021

Actual Primary Completion Date :

Nov 30, 2021

Anticipated Study Completion Date :

Dec 30, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in low-density lipoprotein (LDL) cholesterol concentration (%) [0 vs 3 weeks]
Mean relative change in serum LDL cholesterol concentration during the intervention

Secondary Outcome Measures

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
High density lipoprotein (HDL) cholesterol concentration [0 vs 3 weeks]
Changes in serum HDL cholesterol concentration during the intervention
non-HDL cholesterol concentration [0 vs 3 weeks]
Changes in serum non-HDL cholesterol concentration during the intervention
Total triglyceride concentration [0 vs 3 weeks]
Changes in serum triglycerides concentrations
Nuclear magnetic resonance (NMR) blood biomarkers [0 vs 3 weeks]
Changes in specific NMR blood biomarkers

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nightingale Health plc	Helsinki		Finland	00330

Sponsors and Collaborators

Raisio Group

Investigators

Principal Investigator: Helena Gylling, Helsinki University Hospital, Helsinki, Finland

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Raisio Group

ClinicalTrials.gov Identifier:

NCT05126056

Other Study ID Numbers:

NGH2

First Posted:

Nov 18, 2021

Last Update Posted:

Dec 3, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypercholesterolemia

Study Results

No Results Posted as of Dec 3, 2021