Lipid-lowering Effect of Plant Stanol Drink

October 6, 2020 updated by: Raisio Group

The Effect of Plant Stanol Drink on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden
        • Good Food Practice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drink that contains plant stanols
Dietary supplement: Plant stanol
Dietary supplement: Drink that contains plant stanols
Placebo Comparator: Placebo drink
Dietary supplement: Placebo
Dietary supplement: Placebo drink

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum LDL cholesterol
Time Frame: 0 vs 4 weeks
0 vs 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Raisio Group

Investigators

  • Principal Investigator: Johan Olsson, PhD, Good Food Practice, Uppsala, Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

May 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

October 25, 2012

First Submitted That Met QC Criteria

October 26, 2012

First Posted (Estimate)

October 29, 2012

Study Record Updates

Last Update Posted (Actual)

October 8, 2020

Last Update Submitted That Met QC Criteria

October 6, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CL2010_029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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