Kinetics of Alkylresorcinol MetabolitesRye-kineticsNCT00953836
Plasma Pharmacokinetics of Alkylresorcinol Metabolites; New Candidate Biomarkers for Whole Grain Rye and Wheat Intake
An observational study of Kinetics of Alkylresorcinol Metabolites, run by University of Helsinki at 1 site in Finland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Kinetics of Alkylresorcinol Metabolites
- How many people
- 15 participants
- Where
- 1 siteFinland
- Study dates
- Mar 2009to May 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: healthy, free-living females and males
Who may be able to join
- Healthy, volunteer
Who cannot join
- Hemoglobin below 125 mmol/L in females and below 135 mmol/L in males use of antibiotics within 3 months before entering the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Kinetic Study of Two Known Alkylresorcinol Metabolites in Human Subjects After the Intake of Rye Fiber, the Most Abundant Source of Alkylresorcinols in Diet.
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.
- Conditions
- Kinetics of Alkylresorcinol Metabolites
- Keywords
- kinetics, alkylresorcinol metabolites, rye fiber
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kinetics of Alkylresorcinol MetabolitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- Samfundet Folkhälsan, Sigrid Jusélius Foundation
- Investigators
- Matti J Tikkanen, M.D., prof., Study director, Department of Medicine, University of Helsinki, Helsinki, Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00953836
- Sponsor's protocol ID
- 22/13/03/00/09
- Acronym
- Rye-kinetics
- Status last verified
- Aug 2009
- First submitted
- 5 Aug 2009
- Last updated
- 6 Aug 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kinetic Study of Two Known Alkylresorcinol Metabolites in Human Subjects After the Intake of Rye Fiber, the Most Abundant Source of Alkylresorcinols in Diet.
- ClinicalTrials.gov ID
- NCT00953836
- Acronym / sponsor ID
- Rye-kinetics / 22/13/03/00/09
- Conditions
- Kinetics of Alkylresorcinol Metabolites
- Keywords
- kinetics, alkylresorcinol metabolites, rye fiber
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- Samfundet Folkhälsan, Sigrid Jusélius Foundation
- Study start
- Mar 2009
- Primary completion
- Apr 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 6 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- healthy, free-living females and males
Key inclusion criteria (1 listed)
- Healthy, volunteer
Key exclusion criteria (1 listed)
- Hemoglobin below 125 mmol/L in females and below 135 mmol/L in males use of antibiotics within 3 months before entering the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2009.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matti J Tikkanen, M.D., prof. study director
Department of Medicine, University of Helsinki, Helsinki, Finland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kinetics of Alkylresorcinol Metabolites, run by University of Helsinki at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2009.