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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
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Raisio Group
ClinicalTrials.gov Identifier: NCT01716390     History of Changes
Other Study ID Numbers: CL2010_029
First Submitted: October 25, 2012
First Posted: October 29, 2012
Last Update Posted: October 29, 2012
Last Verified: October 2012

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