MalnutritionNCT02831400
Changes in Circulatory I-FABP in Elderly Persons in Daily Life
A study testing Walking test and Standard Meal in people with Malnutrition and Intestinal Integrity, run by University Medical Center Groningen.
Trial 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. Read more about this study
- Who is it for?
- Ages 75 years and olderHealthy volunteers can take part
- Conditions the study is for
- Malnutrition, Intestinal Integrity, Intestinal Fatty Acid Binding Protein (IFABP)
- What is being tested?
- Walking test and Standard Meal
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- Jul 2016to Jun 2017
- Phase
- Interventional
- 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 75 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Age 75 years or older (both sexes)
- Participating in the Embrace project.
Who cannot join
- Previous gastrointestinal resections
- Chronic inflammatory gastrointestinal disease
About this study
Official title: 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.
- Being tested
- Walking test, Standard Meal
- Medical subject headings
- Malnutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking testBehavioural
Walking test to increase cardiac output, maximum 12 minutes
Standard MealBehavioural
After the walking test, volunteers eat a standard warm meal
| Study group | Role | What they receive |
|---|---|---|
| IFABP assessment (1 study group) | Experimental | 30 elderly volunteers Receives: Behavioral: Walking test; Behavioral: Standard Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
50% increase of I-FABP in plasma.
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionDec 2016
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalnutritionStudies of the same condition, open and under way.
- More trials run by University Medical Center GroningenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Center Groningen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suzanne Stokmans, University Medical Center Groningen
- Investigators
- BL van Leeuwen, MD, PhD, Principal investigator, University Medical Center GroningenJJ de Haan, MD, PhD, Principal investigator, University Medical Center Groningen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02831400
- Sponsor's protocol ID
- NL54574.042.16
- Status last verified
- Jun 2017
- First submitted
- 7 Jul 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Circulatory I-FABP in Elderly Persons in Daily Life: A Pilot Study
- ClinicalTrials.gov ID
- NCT02831400
- Acronym / sponsor ID
- NL54574.042.16
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University Medical Center GroningenUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Dec 2016 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 13 Jul 2016 (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 detect changes in circulatory I-FABP values (50% increase) in elderly volunteers following the combination of moderate physical activity and a standard meal.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IFABP assessment (1 study group) | Experimental | Behavioral: Walking test, Behavioral: Standard Meal30 elderly volunteers |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Age 75 years or older (both sexes)
- Participating in the Embrace project.
Key exclusion criteria (2 listed)
- Previous gastrointestinal resections
- Chronic inflammatory gastrointestinal disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Walking testWalking test to increase cardiac output, maximum 12 minutes | Behavioural | IFABP assessment (1 study group) |
| Standard MealAfter the walking test, volunteers eat a standard warm meal | Behavioural | IFABP assessment (1 study group) |
Primary outcome
50% increase of I-FABP in plasma.
Time frame: 2 hours
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 8 Jun 2017.
- Individual participant dataSharing planned: No
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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.
BL van Leeuwen, MD, PhD principal investigator
University Medical Center Groningen
JJ de Haan, MD, PhD principal investigator
University Medical Center Groningen
Questions about this trial
What is this clinical trial studying?
A study testing Walking test and Standard Meal in people with Malnutrition and Intestinal Integrity, run by University Medical Center Groningen.
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 2 inclusion and 2 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does the primary outcome measure?
50% increase of I-FABP in plasma. (time frame: 2 hours). It is what the study was designed to measure, not a finding.
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 8 Jun 2017; AzTrials last refreshed its copy on 6 Nov 2026.