Lipid-lowering Effect of Plant Stanol Drink

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01716390
• Other study ID #: CL2010_029
• Status: Completed
• Phase: N/A
• Start date: January 2011
• Est. completion date: June 2011

Study information

• Verified date: October 2020
• Source: Raisio Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Dietary Supplement:
• Drink that contains plant stanols

• Placebo drink

Locations

Country	Name	City	State
Sweden	Good Food Practice	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Raisio Group

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in serum LDL cholesterol		0 vs 4 weeks