DOSE: Effect of Plant Stanols on Cholesterol Absorption

• Sponsor: Oy Foodfiles Ltd (Other)
• Overall Status: Completed
• CT.gov ID: NCT00441857
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Duration (Months): 2
• Patients Per Site Per Month: 29.9

Study Details

Study Description

Brief Summary

This study aims to measure the effect of three different doses of plant stanols in margarine on the cholesterol absorption efficiency in subjects with mildly to moderately increased serum LDL cholesterol concentrations

Condition or Disease	Intervention/Treatment	Phase
Hypercholesterolemia	Behavioral: plant stanol consumption	Phase 4

Detailed Description

Serum cholesterol lowering effect of plant sterols is well established and it is also known that plant stanols inhibit the absorption of cholesterol. However, there is lack of dose-response studies directly measuring the cholesterol absorption efficiency during prolonged consumption of plant stanols. Therefore this study aims to measure the cholesterol absorption efficiency at different plant stanol consumption levels using a stable isotope tracer method.

Subjects will be randomized in their study groups that consume 20 g of margarine with different doses of plants stanols (0.8, 1.6 and 2.0g) based on cholesterol absorption efficiency at screening (high and low absorbers randomised separately). Cholesterol absorption test with cholesterol tracer will be conducted twice: at baseline and after 2-3 weeks margarine consumption period.

Cholesterol absorption efficiency will also be examined by indirect method i.e. by following the concentrations of serum cholesterol precursors and plant sterols in blood. In addition serum total, LDL and HDL cholesterol and triglycerides are followed.

Study Design

• Study Type: Interventional
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double
• Primary Purpose: Treatment
• Official Title: The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency
• Study Start Date: Mar 1, 2007
• Actual Study Completion Date: May 1, 2007

Outcome Measures

Primary Outcome Measures

1. cholesterol absorption efficiency []

Secondary Outcome Measures

1. changes in blood lipids []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 68 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• healthy adults with mild to moderate hypercholesterolemia

Exclusion Criteria:

• lipid lowering medication

• pregnancy or lactation

• severe diseases (inc. diabetes, unstable CVD, malignant diseases)

• severe obesity

• regular plant sterol consumption

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oy Foodfiles Ltd	Kuopio		Finland	70210

Sponsors and Collaborators

• Oy Foodfiles Ltd

Investigators

• Principal Investigator: Sakari A Nieminen, MD, Oy Foodfiles Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00441857
• Other Study ID Numbers: DOSE
• First Posted: Mar 1, 2007
• Last Update Posted: Jul 6, 2007
• Last Verified: Jul 1, 2007

• Keywords provided by , ,: plant sterols; plant stanols; cholesterol absorption
• Additional relevant MeSH terms: Hypercholesterolemia

Study Results

No Results Posted as of Jul 6, 2007