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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
History of Changes
  Purpose

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


Condition Intervention
Hypercholesterolemia
 Dietary Supplement: Drink that contains plant stanols
Dietary Supplement: Placebo drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

Further study details as provided by Raisio Group:

Primary Outcome Measures:
  • Change in serum LDL cholesterol [ Time Frame: Four weeks ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: January 2011
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01716390

Locations
Sweden
Good Food Practice
Uppsala, Sweden
Sponsors and Collaborators
Raisio Group
Investigators
Principal Investigator: Johan Olsson, PhD Good Food Practice, Uppsala, Sweden
  More Information

No publications provided

Responsible Party: Raisio Group
ClinicalTrials.gov Identifier: NCT01716390     History of Changes
Other Study ID Numbers: CL2010_029
Study First Received: October 25, 2012
Last Updated: October 26, 2012
Health Authority: Sweden: Institutional Review Board

Additional relevant MeSH terms:
Hypercholesterolemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on May 16, 2013