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Changes in Circulatory I-FABP in Elderly Persons in Daily Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02831400
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : June 8, 2017
Information provided by (Responsible Party):
Suzanne Stokmans, University Medical Center Groningen

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.

Condition or disease Intervention/treatment Phase
Malnutrition Intestinal Integrity Intestinal Fatty Acid Binding Protein (IFABP) Behavioral: Walking test Behavioral: Standard Meal Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Changes in Circulatory I-FABP in Elderly Persons in Daily Life: A Pilot Study
Actual Study Start Date : July 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Arm Intervention/treatment
Experimental: IFABP assessment (1 study group)
30 elderly volunteers
Behavioral: Walking test
Walking test to increase cardiac output, maximum 12 minutes

Behavioral: Standard Meal
After the walking test, volunteers eat a standard warm meal

Primary Outcome Measures :
  1. 50% increase of I-FABP in plasma. [ Time Frame: 2 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   75 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Age 75 years or older (both sexes)
  2. Participating in the Embrace project.

Exclusion Criteria:

  1. Previous gastrointestinal resections
  2. Chronic inflammatory gastrointestinal disease

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02831400

Sponsors and Collaborators
University Medical Center Groningen
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Principal Investigator: BL van Leeuwen, MD, PhD University Medical Center Groningen
Principal Investigator: JJ de Haan, MD, PhD University Medical Center Groningen

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Responsible Party: Suzanne Stokmans, MD, PhD candidate, University Medical Center Groningen Identifier: NCT02831400    
Other Study ID Numbers: NL54574.042.16
First Posted: July 13, 2016    Key Record Dates
Last Update Posted: June 8, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Nutrition Disorders