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Plant Stanol Ester Beverage and Ileostoma Patients (STOMA)

This study has been completed.
Sponsor:
Information provided by:
Helsinki University
ClinicalTrials.gov Identifier:
NCT00846937
First received: February 18, 2009
Last updated: February 9, 2011
Last verified: February 2009
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Plant Stanolester Beverage on Cholesterol Metabolism Among Human Subjects With Ileostoma

Resource links provided by NLM:

MedlinePlus related topics: Cholesterol
U.S. FDA Resources

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
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Dietary Supplement: Plant stanolester and fatty acid
    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
Sponsors and Collaborators
Helsinki University
Investigators
Principal Investigator: Markku J. Nissinen, MD,PhD Helsinki University
Study Director: Tatu Miettinen, Professor Helsinki University
  More Information

No publications provided

Responsible Party: Markku Nissinen/ MD, PhD, Dept. of Medicine, Div. of Gastroenterology
ClinicalTrials.gov Identifier: NCT00846937     History of Changes
Other Study ID Numbers: 3097, U1010G0020
Study First Received: February 18, 2009
Last Updated: February 9, 2011
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 21, 2013