Lipid-lowering Effect of Plant Stanol Drink

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Raisio Group
ClinicalTrials.gov Identifier:
NCT01716390
First received: October 25, 2012
Last updated: October 26, 2012
Last verified: October 2012

October 25, 2012
October 26, 2012
January 2011
May 2011   (final data collection date for primary outcome measure)
Change in serum LDL cholesterol [ Time Frame: Four weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01716390 on ClinicalTrials.gov Archive Site
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   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
Both
25 Years to 65 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01716390
CL2010_029
No
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