Status unknownNCT05126056Updated Dec 3, 2021

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

An interventional study of Plant stanol ester and Placebo in Hypercholesterolemia, sponsored by Raisio Group. Status unknown at 1 site in Finland. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-12-03.

Sponsored by Raisio Group · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2021), so the status shown — last known as Active, not recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 55
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Conditions studied

Hypercholesterolemia

Browse trials for

Hypercholesterolemia 1,238

In context

Hypercholesterolemia

1,238 studies on the registry are indexed under Hypercholesterolemia; 109 are open to participants now.

This study's planned enrollment of 55 is below the median of 99 across 991 interventional studies indexed under Hypercholesterolemia.

Browse Hypercholesterolemia studies →

Lead sponsor

Raisio Group is the lead sponsor of 9 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: 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

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 55 participants (estimated)

Study arms

Active comparator
Active Comparator
Products that contain plant stanol ester. Product with active ingredient
Other: Plant stanol ester
Placebo comparator
Placebo comparator
Placebo product. Product without active ingredient
Other: Placebo

Interventions

OtherPlant stanol ester
Product with active ingredient vs product without active ingredient
OtherPlacebo
Placebo

What researchers measure

Primary outcomes

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

Secondary outcomes

LDL cholesterol concentration
Mean absolute change in serum LDL cholesterol concentration during the intervention between test and control group
Time frame: 0 vs 3 weeks
total cholesterol concentration
Changes in serum total cholesterol concentration during the intervention
Time frame: 0 vs 3 weeks
High density lipoprotein (HDL) cholesterol concentration
Changes in serum HDL cholesterol concentration during the intervention
Time frame: 0 vs 3 weeks
non-HDL cholesterol concentration
Changes in serum non-HDL cholesterol concentration during the intervention
Time frame: 0 vs 3 weeks
Total triglyceride concentration
Changes in serum triglycerides concentrations
Time frame: 0 vs 3 weeks
Nuclear magnetic resonance (NMR) blood biomarkers
Changes in specific NMR blood biomarkers
Time frame: 0 vs 3 weeks

Study locations

1 site

Nightingale Health plc
Helsinki, 00330, Finland

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Dec 3, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05126056
Lead sponsor: Raisio Group
Responsible party: Sponsor
First posted: Nov 18, 2021
Start date: Sep 1, 2021
Primary completion: Nov 30, 2021
Completion: Dec 30, 2021 (estimated)
Last update: Dec 3, 2021

Study contacts

Helena Gylling

principal investigator · Helsinki University Hospital, Helsinki, Finland

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Hypercholesterolemia→

Other studies from this sponsor

Raisio Group

Start the discussion