Back to resultsChanges in Circulatory I-FABP in Elderly Persons in Daily Life
Primary Purpose
Malnutrition, Intestinal Integrity, Intestinal Fatty Acid Binding Protein (IFABP)
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Walking test
Standard Meal
Sponsored by
About this trial
This is an interventional diagnostic trial for Malnutrition
Eligibility Criteria
Inclusion Criteria:
- Age 75 years or older (both sexes)
- Participating in the Embrace project.
Exclusion Criteria:
- Previous gastrointestinal resections
- Chronic inflammatory gastrointestinal disease
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IFABP assessment (1 study group)
Arm Description
30 elderly volunteers
Outcomes
Primary Outcome Measures
50% increase of I-FABP in plasma.
Secondary Outcome Measures
Full Information
NCT ID
NCT02831400
First Posted
July 7, 2016
Last Updated
June 7, 2017
Sponsor
University Medical Center Groningen
1. Study Identification
Unique Protocol Identification Number
NCT02831400
Brief Title
Changes in Circulatory I-FABP in Elderly Persons in Daily Life
Official Title
Changes in Circulatory I-FABP in Elderly Persons in Daily Life: A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
July 2016 (Actual)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Medical Center Groningen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malnutrition, Intestinal Integrity, Intestinal Fatty Acid Binding Protein (IFABP)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IFABP assessment (1 study group)
Arm Type
Experimental
Arm Description
30 elderly volunteers
Intervention Type
Behavioral
Intervention Name(s)
Walking test
Intervention Description
Walking test to increase cardiac output, maximum 12 minutes
Intervention Type
Behavioral
Intervention Name(s)
Standard Meal
Intervention Description
After the walking test, volunteers eat a standard warm meal
Primary Outcome Measure Information:
Title
50% increase of I-FABP in plasma.
Time Frame
2 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 75 years or older (both sexes)
Participating in the Embrace project.
Exclusion Criteria:
Previous gastrointestinal resections
Chronic inflammatory gastrointestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BL van Leeuwen, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
JJ de Haan, MD, PhD
Organizational Affiliation
University Medical Center Groningen
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Changes in Circulatory I-FABP in Elderly Persons in Daily Life
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