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

NCT05064644 | Completed

• 1 other identifier: NGH1
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

• Change in LDL cholesterol concentration (%)

  Mean relative change in serum LDL cholesterol concentration during the intervention

  0 vs 3 weeks

Secondary Outcomes (6)

• LDL cholesterol concentration

  0 vs 3 weeks

• total cholesterol concentration

  0 vs 3 weeks

• HDL cholesterol concentration

  0 vs 3 weeks

• non-HDL cholesterol concentration

  0 vs 3 weeks

• Total triglyceride concentration

  0 vs 3 weeks

Study Arms (2)

Plant stanol ester comparator

ACTIVE COMPARATOR

Product that contains plant stanol ester

Other: Product that contains plant stanol ester

Placebo comparator

PLACEBO COMPARATOR

Placebo product

Other: Placebo product

Interventions

Product that contains plant stanol ester OTHER

Product with active ingredient

Plant stanol ester comparator

Placebo product OTHER

Product without active ingredient

Placebo comparator

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Raisio Group: lead

Study Sites (1)

Nightingale Health plc

Helsinki, 00330, Finland

Location

MeSH Terms

Conditions

Hypercholesterolemia

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Helena Gylling, MD

  Helsinki University Hospital, Helsinki, Finland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2021
• First Posted: October 1, 2021
• Study Start: August 1, 2021
• Primary Completion: October 30, 2021
• Study Completion: November 30, 2021
• Last Updated: December 3, 2021

Record last verified: 2021-12

Locations

FI (1)