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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 01, 2014