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Effect of Plant Stanols on Cholesterol Absorption (DOSE)

Primary Purpose

Hypercholesterolemia

Status
Completed
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
plant stanol consumption
Sponsored by
Oy Foodfiles Ltd
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypercholesterolemia focused on measuring plant sterols, plant stanols, cholesterol absorption

Eligibility Criteria

25 Years - 68 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Oy Foodfiles Ltd

Outcomes

Primary Outcome Measures

cholesterol absorption efficiency

Secondary Outcome Measures

changes in blood lipids

Full Information

First Posted
February 28, 2007
Last Updated
July 4, 2007
Sponsor
Oy Foodfiles Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT00441857
Brief Title
Effect of Plant Stanols on Cholesterol Absorption
Acronym
DOSE
Official Title
The Effect of Three Different Stanol Ester Doses in Margarines on Cholesterol Absorption Efficiency
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Completed
Study Start Date
March 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Oy Foodfiles Ltd

4. Oversight

Data Monitoring Committee
No

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
plant sterols, plant stanols, cholesterol absorption

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
60 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
plant stanol consumption
Primary Outcome Measure Information:
Title
cholesterol absorption efficiency
Secondary Outcome Measure Information:
Title
changes in blood lipids

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
68 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sakari A Nieminen, MD
Organizational Affiliation
Oy Foodfiles Ltd
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oy Foodfiles Ltd
City
Kuopio
ZIP/Postal Code
70210
Country
Finland

12. IPD Sharing Statement

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Effect of Plant Stanols on Cholesterol Absorption

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