Lipid-lowering Effect of Plant Stanol Drink

NCT ID: NCT01716390

Last Updated: 2020-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To determine the effect of investigational products on serum LDL cholesterol.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypercholesterolemia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Drink that contains plant stanols

Dietary supplement: Plant stanol

Group Type ACTIVE_COMPARATOR

Drink that contains plant stanols

Intervention Type DIETARY_SUPPLEMENT

Placebo drink

Dietary supplement: Placebo

Group Type PLACEBO_COMPARATOR

Placebo drink

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Drink that contains plant stanols

Intervention Type DIETARY_SUPPLEMENT

Placebo drink

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* healthy mildly to moderate hypercholesterolemic (serum total cholesterol 5.2-8.5 mmol/l) adults
* signed written informed consent

Exclusion Criteria

* participation in a clinical study within 30 days prior to screening visit and throughout the study
* severe obesity
* consumption of lipid/cholesterol lowering medication 1 month prior to the screening visit and throughout the study
* consumption of plant stanol or plant sterol containing food products such as Benecol or Becel pro active 1 month prior to visit 2
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Raisio Group

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Johan Olsson, PhD

Role: PRINCIPAL_INVESTIGATOR

Good Food Practice, Uppsala, Sweden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Good Food Practice

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Hallikainen M, Olsson J, Gylling H. Low-Fat Nondairy Minidrink Containing Plant Stanol Ester Effectively Reduces LDL Cholesterol in Subjects with Mild to Moderate Hypercholesterolemia as Part of a Western Diet. Cholesterol. 2013;2013:192325. doi: 10.1155/2013/192325. Epub 2013 Sep 16.

Reference Type DERIVED
PMID: 24151550 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CL2010_029

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.