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Lipid-lowering Effect of Plant Stanol Drink

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01716390
First Posted: October 29, 2012
Last Update Posted: October 29, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Raisio Group
October 25, 2012
October 29, 2012
October 29, 2012
January 2011
May 2011   (Final data collection date for primary outcome measure)
Change in serum LDL cholesterol [ Time Frame: Four weeks ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Lipid-lowering Effect of Plant Stanol Drink
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hypercholesterolemia
  • Dietary Supplement: Drink that contains plant stanols
  • Dietary Supplement: Placebo drink
  • Active Comparator: Drink that contains plant stanols
    Dietary supplement: Plant stanol
    Intervention: Dietary Supplement: Drink that contains plant stanols
  • Placebo Comparator: Placebo drink
    Dietary supplement: Placebo
    Intervention: Dietary Supplement: Placebo drink
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
56
June 2011
May 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
25 Years to 65 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
 
NCT01716390
CL2010_029
No
Not Provided
Not Provided
Raisio Group
Raisio Group
Not Provided
Principal Investigator: Johan Olsson, PhD Good Food Practice, Uppsala, Sweden
Raisio Group
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP