NCT00953836

Brief Summary

The purpose of this study is to investigate the kinetics of two known alkylresorcinol metabolites in human subjects after intake of high-fiber rye bread. Whole grain rye is the most abundant source of alkylresorcinols.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2009

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2009

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
Last Updated

August 6, 2009

Status Verified

August 1, 2009

Enrollment Period

1 month

First QC Date

August 5, 2009

Last Update Submit

August 5, 2009

Conditions

Kinetics of Alkylresorcinol Metabolites

Keywords

kineticsalkylresorcinol metabolitesrye fiber

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

healthy, free-living females and males

You may qualify if:

  • Healthy, volunteer

You may not qualify if:

  • Hemoglobin below 125 mmol/L in females and below 135 mmol/L in males use of antibiotics within 3 months before entering the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Folkhälsan Research Center

Helsinki, 00250, Finland

Location

Study Officials

  • Matti J Tikkanen, M.D., prof.

    Department of Medicine, University of Helsinki, Helsinki, Finland

    STUDY DIRECTOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 5, 2009

First Posted

August 6, 2009

Study Start

March 1, 2009

Primary Completion

April 1, 2009

Study Completion

May 1, 2009

Last Updated

August 6, 2009

Record last verified: 2009-08

Locations

FI(1)