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OpenTrials
Completed

NCT Number: NCT05064644

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

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

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nightingale Health plc

Helsinki, 00330, Finland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Product that contains plant stanol ester

Other

Product with active ingredient

Placebo product

Other

Product without active ingredient

Primary outcomes

  1. Change in LDL cholesterol concentration (%)

    Time frame: 0 vs 3 weeks

    Mean relative change in serum LDL cholesterol concentration during the intervention

Secondary outcomes

  1. LDL cholesterol concentration

    Time frame: 0 vs 3 weeks

    Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group

  2. total cholesterol concentration

    Time frame: 0 vs 3 weeks

    Changes in serum total cholesterol concentration during the intervention

  3. HDL cholesterol concentration

    Time frame: 0 vs 3 weeks

    Changes in serum HDL cholesterol concentration during the intervention

  4. non-HDL cholesterol concentration

    Time frame: 0 vs 3 weeks

    Changes in serum non-HDL cholesterol concentration during the intervention

  5. Total triglyceride concentration

    Time frame: 0 vs 3 weeks

    Changes in serum triglycerides concentrations

  6. NMR blood biomarkers

    Time frame: 0 vs 3 weeks

    Changes in specific NMR blood biomarkers

Sponsors and collaborators

Lead sponsor

Raisio Group

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Oct 1, 2021
Registry last updated
Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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