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Plant Stanol Ester Beverage and Ileostoma Patients (STOMA)

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ClinicalTrials.gov Identifier: NCT00846937
Recruitment Status : Completed
First Posted : February 19, 2009
Last Update Posted : February 10, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Ileostoma Dietary Supplement: Plant stanolester and fatty acid

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effects of a Plant Stanolester Beverage on Cholesterol Metabolism Among Human Subjects With Ileostoma
Study Start Date : February 2009
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. serum cholesterol level [ Time Frame: After treatment perdiods ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • healthy proctocolectomized subjects with an ileostoma

Exclusion Criteria:

  • Chronic illness
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: February 19, 2009    Key Record Dates
Last Update Posted: February 10, 2011
Last Verified: February 2009

Keywords provided by Helsinki University:
Cholesterol
Plant stanolester
Beverage
Ileostoma
Serum cholesterol level
serum LDL-cholesterol level
Intestinal cholesterol absorption efficiency