NCT00846937

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

February 10, 2011

Status Verified

February 1, 2009

Enrollment Period

1.2 years

First QC Date

February 18, 2009

Last Update Submit

February 9, 2011

Conditions

Ileostoma

Keywords

CholesterolPlant stanolesterBeverageIleostomaSerum cholesterol levelserum LDL-cholesterol levelIntestinal cholesterol absorption efficiency

Outcome Measures

Primary Outcomes (1)

  • serum cholesterol level

    After treatment perdiods

Interventions

Plant stanolester and fatty acidDIETARY_SUPPLEMENT

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

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy proctocolectomized subjects with an ileostoma

You may not qualify if:

  • Chronic illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Helsinki, Department of Medicine

Helsinki, 00029, Finland

Location

MeSH Terms

Interventions

Fatty Acids

Intervention Hierarchy (Ancestors)

Lipids

Study Officials

  • Markku J. Nissinen, MD,PhD

    University of Helsinki

    PRINCIPAL INVESTIGATOR

  • Tatu Miettinen, Professor

    University of Helsinki

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

February 10, 2011

Record last verified: 2009-02

Locations

FI(1)