NCT02831400

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2016

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

July 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

July 7, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 13, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 8, 2017

Status Verified

June 1, 2017

Enrollment Period

5 months

First QC Date

July 7, 2016

Last Update Submit

June 7, 2017

Conditions

MalnutritionIntestinal IntegrityIntestinal Fatty Acid Binding Protein (IFABP)

Outcome Measures

Primary Outcomes (1)

  • 50% increase of I-FABP in plasma.

    2 hours

Study Arms (1)

IFABP assessment (1 study group)

EXPERIMENTAL

30 elderly volunteers

Behavioral: Walking testBehavioral: Standard Meal

Interventions

Walking testBEHAVIORAL

Walking test to increase cardiac output, maximum 12 minutes

IFABP assessment (1 study group)
Standard MealBEHAVIORAL

After the walking test, volunteers eat a standard warm meal

IFABP assessment (1 study group)

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Previous gastrointestinal resections
  • Chronic inflammatory gastrointestinal disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Malnutrition

Condition Hierarchy (Ancestors)

Nutrition DisordersNutritional and Metabolic Diseases

Study Officials

  • BL van Leeuwen, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

  • JJ de Haan, MD, PhD

    University Medical Center Groningen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD candidate

Study Record Dates

First Submitted

July 7, 2016

First Posted

July 13, 2016

Study Start

July 1, 2016

Primary Completion

December 1, 2016

Study Completion

June 1, 2017

Last Updated

June 8, 2017

Record last verified: 2017-06

Data Sharing

IPD Sharing
Will not share