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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 30, 2014