- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02831400
Changes in Circulatory I-FABP in Elderly Persons in Daily Life
June 7, 2017 updated by: Suzanne Stokmans, University Medical Center Groningen
Changes in Circulatory I-FABP in Elderly Persons in Daily Life: A Pilot Study
The purpose of this study is to detect changes in circulatory I-FABP values (50% increase) in elderly volunteers following the combination of moderate physical activity and a standard meal.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
75 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 75 years or older (both sexes)
- Participating in the Embrace project.
Exclusion Criteria:
- Previous gastrointestinal resections
- Chronic inflammatory gastrointestinal disease
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: IFABP assessment (1 study group)
30 elderly volunteers
|
Walking test to increase cardiac output, maximum 12 minutes
After the walking test, volunteers eat a standard warm meal
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
50% increase of I-FABP in plasma.
Time Frame: 2 hours
|
2 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: BL van Leeuwen, MD, PhD, University Medical Center Groningen
- Principal Investigator: JJ de Haan, MD, PhD, University Medical Center Groningen
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
June 1, 2017
Study Registration Dates
First Submitted
July 7, 2016
First Submitted That Met QC Criteria
July 10, 2016
First Posted (Estimate)
July 13, 2016
Study Record Updates
Last Update Posted (Actual)
June 8, 2017
Last Update Submitted That Met QC Criteria
June 7, 2017
Last Verified
June 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NL54574.042.16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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