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Lipid-lowering Effect of Plant Stanol Drink

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Drink that contains plant stanols
Placebo drink
Sponsored by
Raisio Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Good Food Practice

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Drink that contains plant stanols

Placebo drink

Arm Description

Dietary supplement: Plant stanol

Dietary supplement: Placebo

Outcomes

Primary Outcome Measures

Change in serum LDL cholesterol

Secondary Outcome Measures

Full Information

First Posted
October 25, 2012
Last Updated
October 6, 2020
Sponsor
Raisio Group
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1. Study Identification

Unique Protocol Identification Number
NCT01716390
Brief Title
Lipid-lowering Effect of Plant Stanol Drink
Official Title
The Effect of Plant Stanol Drink on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Raisio Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Drink that contains plant stanols
Arm Type
Active Comparator
Arm Description
Dietary supplement: Plant stanol
Arm Title
Placebo drink
Arm Type
Placebo Comparator
Arm Description
Dietary supplement: Placebo
Intervention Type
Dietary Supplement
Intervention Name(s)
Drink that contains plant stanols
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo drink
Primary Outcome Measure Information:
Title
Change in serum LDL cholesterol
Time Frame
0 vs 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johan Olsson, PhD
Organizational Affiliation
Good Food Practice, Uppsala, Sweden
Official's Role
Principal Investigator
Facility Information:
Facility Name
Good Food Practice
City
Uppsala
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
24151550
Citation
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.
Results Reference
derived

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Lipid-lowering Effect of Plant Stanol Drink

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