NCT05126056

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 9, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

December 3, 2021

Status Verified

December 1, 2021

Enrollment Period

3 months

First QC Date

November 9, 2021

Last Update Submit

December 2, 2021

Conditions

Hypercholesterolemia

Outcome Measures

Primary Outcomes (1)

  • Change in low-density lipoprotein (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

  • High density lipoprotein (HDL) cholesterol concentration

    0 vs 3 weeks

  • non-HDL cholesterol concentration

    0 vs 3 weeks

  • Total triglyceride concentration

    0 vs 3 weeks

  • +1 more secondary outcomes

Study Arms (2)

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

Plant stanol esterOTHER

Product with active ingredient vs product without active ingredient

Active Comparator
PlaceboOTHER

Placebo

Placebo comparator

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (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 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nightingale Health plc

Helsinki, 00330, Finland

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

plant stanol ester

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Helena Gylling

    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

November 9, 2021

First Posted

November 18, 2021

Study Start

September 1, 2021

Primary Completion

November 30, 2021

Study Completion

December 30, 2021

Last Updated

December 3, 2021

Record last verified: 2021-12

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)