Plant Stanol Ester Beverage and Ileostoma Patients

NCT ID: NCT00846937

Last Updated: 2011-02-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-05-31

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.

Conditions

Ileostoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Interventions

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

Inclusion Criteria

• healthy proctocolectomized subjects with an ileostoma

Exclusion Criteria

• Chronic illness

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Helsinki

OTHER

Sponsor Role: lead

Responsible Party

Dept. of Medicine, Div. of Gastroenterology

Principal Investigators

Markku J. Nissinen, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University of Helsinki

Tatu Miettinen, Professor

Role: STUDY_DIRECTOR

University of Helsinki

Locations

University of Helsinki, Department of Medicine

Helsinki, , Finland

Countries

Finland

Other Identifiers

U1010G0020

Identifier Type: -

Identifier Source: secondary_id

3097

Identifier Type: -

Identifier Source: org_study_id