DyspepsiaNCT02592239
Hedonic Perception and Brain Activity Response to Meal
A study testing Functional brain MRI and A warm ham and cheese sandwich and a 200 ml fruit juice in people with Dyspepsia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
The purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Dyspepsia
- What is being tested?
- Functional brain MRI and A warm ham and cheese sandwich and a 200 ml fruit juice
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- Nov 2014to 30 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age between 18 and 80 yrs
- Body mass index between 18-30 Kg/m2
- Right-handed
Who cannot join
- Subjects with clinical history of eating-disorders
- Subjects with clinical history of significant head-trauma
- Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
- Subjects with a known history of alcohol or drug abuse in the previous 6 months.
- Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
- Women that are pregnant or that are breast-feeding.
- Claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hedonic Perception and Brain Activity Response to Meal in Health and Functional Dyspepsia
The purpose of this study is to determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI.
Read the detailed description
Functional MRI brain imaging will be performed in patients with functional dyspepsia and healthy controls in basal conditions and after a palatable test meal. During the study, the cognitive response and the hedonic dimension will be measured using 10 score scales.
- Conditions
- Dyspepsia
- Being tested
- Functional brain MRI, A warm ham and cheese sandwich and a 200 ml fruit juice
- Keywords
- Functional brain MRI, functional dyspepsia, hedonic response
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional brain MRIDevice
Functional brain MRI before and after test meal ingestion
A warm ham and cheese sandwich and a 200 ml fruit juiceDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| Patients | Experimental | Functional dyspepsia patients will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales. Receives: Device: Functional brain MRI; Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice |
| Controls | Experimental | Healthy subjects recruited by public advertisement will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales. Receives: Device: Functional brain MRI; Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in activity in specific brain regions measured by functional MRI
To determine the brain response to a meal in patients with functional dyspepsia and healthy subjects.
Measured: 3 hours
Cognitive and hedonic perception measured on 10 score scales (composite outcome)
To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.
Measured: 3 hours
Secondary outcomes (1)
Metabolomic response measured in serum by NMR spectroscopy
To identify the metabolomic substrate of the cognitive and brain responses to a meal.
Measured: 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionJun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DyspepsiaStudies of the same condition, open and under way.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02592239
- Sponsor's protocol ID
- PR(AG)214/2012 Addendum
- Status last verified
- Sep 2016
- First submitted
- 17 Mar 2015
- Last updated
- 27 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Malagelada C, Accarino A, Molne L, Mendez S, Campos E, Gonzalez A, Malagelada JR, Azpiroz F. Digestive, cognitive and hedonic responses to a meal. Neurogastroenterol Motil. 2015 Mar;27(3):389-96. doi: 10.1111/nmo.12504. Epub 2015 Jan 3.
PubMed 25557693Liu P, Qin W, Wang J, Zeng F, Zhou G, Wen H, von Deneen KM, Liang F, Gong Q, Tian J. Identifying neural patterns of functional dyspepsia using multivariate pattern analysis: a resting-state FMRI study. PLoS One. 2013 Jul 12;8(7):e68205. doi: 10.1371/journal.pone.0068205. Print 2013.
PubMed 23874543Zeng F, Qin W, Liang F, Liu J, Tang Y, Liu X, Yuan K, Yu S, Song W, Liu M, Lan L, Gao X, Liu Y, Tian J. Abnormal resting brain activity in patients with functional dyspepsia is related to symptom severity. Gastroenterology. 2011 Aug;141(2):499-506. doi: 10.1053/j.gastro.2011.05.003. Epub 2011 May 17.
PubMed 21684280Van Oudenhove L, Vandenberghe J, Dupont P, Geeraerts B, Vos R, Dirix S, Bormans G, Vanderghinste D, Van Laere K, Demyttenaere K, Fischler B, Tack J. Abnormal regional brain activity during rest and (anticipated) gastric distension in functional dyspepsia and the role of anxiety: a H(2)(15)O-PET study. Am J Gastroenterol. 2010 Apr;105(4):913-24. doi: 10.1038/ajg.2010.39. Epub 2010 Feb 16.
PubMed 20160711
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hedonic Perception and Brain Activity Response to Meal in Health and Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT02592239
- Acronym / sponsor ID
- PR(AG)214/2012 Addendum
- Conditions
- Dyspepsia
- Keywords
- Functional brain MRI, functional dyspepsia, hedonic response
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 30 Oct 2015 (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 determine the relationship between brain activity and the perception of subjective hedonic sensations in response to a meal using functional MRI.
Detailed description
Functional MRI brain imaging will be performed in patients with functional dyspepsia and healthy controls in basal conditions and after a palatable test meal. During the study, the cognitive response and the hedonic dimension will be measured using 10 score scales.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | Experimental | Device: Functional brain MRI, Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juiceFunctional dyspepsia patients will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales. |
| Controls | Experimental | Device: Functional brain MRI, Dietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juiceHealthy subjects recruited by public advertisement will be studied using functional brain MRI before and after receiving a test meal. Cognitive and hedonic response will be evaluated using 10 score scales. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 yrs
- Body mass index between 18-30 Kg/m2
- Right-handed
Key exclusion criteria (7 listed)
- Subjects with clinical history of eating-disorders
- Subjects with clinical history of significant head-trauma
- Subjects with known serious illness: clinically significant cardiac, vascular, liver, pulmonary, or psychiatric disorders (as evaluated by the Investigator).
- Subjects with a known history of alcohol or drug abuse in the previous 6 months.
- Subjects using medications with SNS effects that cannot be discontinued, such as: antidepressants, pregabalin, gabapentin.
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 |
|---|---|---|
| Functional brain MRIFunctional brain MRI before and after test meal ingestion | Device | Controls, Patients |
| A warm ham and cheese sandwich and a 200 ml fruit juice | Dietary supplement | Controls, Patients |
Primary outcome
Change in activity in specific brain regions measured by functional MRI
Time frame: 3 hours
To determine the brain response to a meal in patients with functional dyspepsia and healthy subjects.
Cognitive and hedonic perception measured on 10 score scales (composite outcome)
Time frame: 3 hours
To determine the cognitive and hedonic response to a meal in patients with functional dyspepsia and healthy subjects.
1 secondary outcome
Metabolomic response measured in serum by NMR spectroscopy
Time frame: 3 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 27 Jul 2017.
- Background: PubMed 25557693Malagelada C, Accarino A, Molne L, Mendez S, Campos E, Gonzalez A, Malagelada JR, Azpiroz F. Digestive, cognitive and hedonic responses to a meal. Neurogastroenterol Motil. 2015 Mar;27(3):389-96. doi: 10.1111/nmo.12504. Epub 2015 Jan 3.
- Background: PubMed 23874543Liu P, Qin W, Wang J, Zeng F, Zhou G, Wen H, von Deneen KM, Liang F, Gong Q, Tian J. Identifying neural patterns of functional dyspepsia using multivariate pattern analysis: a resting-state FMRI study. PLoS One. 2013 Jul 12;8(7):e68205. doi: 10.1371/journal.pone.0068205. Print 2013.
- Background: PubMed 21684280Zeng F, Qin W, Liang F, Liu J, Tang Y, Liu X, Yuan K, Yu S, Song W, Liu M, Lan L, Gao X, Liu Y, Tian J. Abnormal resting brain activity in patients with functional dyspepsia is related to symptom severity. Gastroenterology. 2011 Aug;141(2):499-506. doi: 10.1053/j.gastro.2011.05.003. Epub 2011 May 17.
- Background: PubMed 20160711Van Oudenhove L, Vandenberghe J, Dupont P, Geeraerts B, Vos R, Dirix S, Bormans G, Vanderghinste D, Van Laere K, Demyttenaere K, Fischler B, Tack J. Abnormal regional brain activity during rest and (anticipated) gastric distension in functional dyspepsia and the role of anxiety: a H(2)(15)O-PET study. Am J Gastroenterol. 2010 Apr;105(4):913-24. doi: 10.1038/ajg.2010.39. Epub 2010 Feb 16.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional brain MRI and A warm ham and cheese sandwich and a 200 ml fruit juice in people with Dyspepsia, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 3 inclusion and 7 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 27 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in activity in specific brain regions measured by functional MRI (time frame: 3 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02592239, which also lists 4 linked publications.
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 27 Jul 2017; AzTrials last refreshed its copy on 30 Oct 2026.