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

Tracking Information

First Received Date ^ICMJE

October 25, 2012

Last Updated Date

October 26, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01716390 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Lipid-lowering Effect of Plant Stanol Drink

Official Title ^ICMJE

The Effect of Plant Stanol Drink on Serum Lipids in Comparison to Placebo in Subjects With Mildly to Moderately Elevated Serum Cholesterol Concentrations

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Hypercholesterolemia

Intervention ^ICMJE

Dietary Supplement: Drink that contains plant stanols
Dietary Supplement: Placebo drink

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2011

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

25 Years to 65 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Sweden

Administrative Information

NCT Number ^ICMJE

NCT01716390

Other Study ID Numbers ^ICMJE

CL2010_029

Has Data Monitoring Committee

Responsible Party

Raisio Group

Study Sponsor ^ICMJE

Raisio Group

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Johan Olsson, PhD

Good Food Practice, Uppsala, Sweden

Information Provided By

Raisio Group

Verification Date

October 2012

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

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