Plant Stanol Ester Beverage and Ileostoma Patients (STOMA)

February 9, 2011 updated by: University of Helsinki

Effects of a Plant Stanolester Beverage on Cholesterol Metabolism Among Human Subjects With Ileostoma

We aim to examine efficacy of a plant stanolester beverage to lower serum cholesterol and LDL-cholesterol levels, when given with or without a fatty acid preparation. Study subjects are otherwise healthy proctocolectomized ileostoma patients (n=10), who consume stanolester beverage with or without a fatty acid preparation in a random order for one week period after a standardized low-fat meal. Washout period is 4 weeks. Serum lipids, lipoprotein lipids, sterols and fecal sterols and variables of cholesterol metabolism will be examined accordingly.

Study Overview

Status

Completed

Conditions

Ileostoma

Intervention / Treatment

Dietary supplement: Plant stanolester and fatty acid

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Finland
- - Helsinki, Finland, 00029
    - University of Helsinki, Department of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

healthy proctocolectomized subjects with an ileostoma

Exclusion Criteria:

Chronic illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Crossover Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum cholesterol level Time Frame: After treatment perdiods	After treatment perdiods

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Investigators

Principal Investigator: Markku J. Nissinen, MD,PhD, University of Helsinki
Study Director: Tatu Miettinen, Professor, University of Helsinki

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)