Plant Stanol Ester Beverage and Ileostoma Patients - Full Text View

Sponsored by:	Helsinki University
Information provided by:	Helsinki University
ClinicalTrials.gov Identifier:	NCT00846937

Purpose

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.

Condition	Intervention
Ileostoma	Dietary Supplement: Plant stanolester and fatty acid

MedlinePlus related topics: Cholesterol

Drug Information available for: Cholest-5-en-3-ol (3beta)-

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Official Title:	Effects of a Plant Stanolester Beverage on Cholesterol Metabolism Among Human Subjects With Ileostoma

Further study details as provided by Helsinki University:

Primary Outcome Measures:

serum cholesterol level [ Time Frame: After treatment perdiods ] [ Designated as safety issue: No ]

Enrollment:	10
Study Start Date:	February 2009
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Plant stanol ester 2gr/day and fatty acid in a beverage compared to plant stanol ester 2gr /day and placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

healthy proctocolectomized subjects with an ileostoma

Exclusion Criteria:

Chronic illness

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00846937

Locations

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

Sponsors and Collaborators

Helsinki University

Investigators

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

More Information

No publications provided

Responsible Party:	Dept. of Medicine, Div. of Gastroenterology ( Markku Nissinen/ MD, PhD )
Study ID Numbers:	3097, U1010G0020
Study First Received:	February 18, 2009
Last Updated:	February 18, 2009
ClinicalTrials.gov Identifier:	NCT00846937 History of Changes
Health Authority:	Finland: Helsinki University

Keywords provided by Helsinki University:

Cholesterol
Plant stanolester
Beverage
Ileostoma

Serum cholesterol level
serum LDL-cholesterol level
Intestinal cholesterol absorption efficiency

ClinicalTrials.gov processed this record on May 07, 2009