NCT02592239

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

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

November 1, 2014

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

March 17, 2015

Completed
8 months until next milestone

First Posted

Study publicly available on registry

October 30, 2015

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

July 27, 2017

Status Verified

September 1, 2016

Enrollment Period

2.6 years

First QC Date

March 17, 2015

Last Update Submit

July 26, 2017

Conditions

Dyspepsia

Keywords

Functional brain MRIfunctional dyspepsiahedonic response

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3 hours

Secondary Outcomes (1)

  • Metabolomic response measured in serum by NMR spectroscopy

    3 hours

Study Arms (2)

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.

Device: Functional brain MRIDietary 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.

Device: Functional brain MRIDietary Supplement: A warm ham and cheese sandwich and a 200 ml fruit juice

Interventions

Functional brain MRIDEVICE

Functional brain MRI before and after test meal ingestion

ControlsPatients
A warm ham and cheese sandwich and a 200 ml fruit juiceDIETARY_SUPPLEMENT
ControlsPatients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age between 18 and 80 yrs
  • Body mass index between 18-30 Kg/m2
  • Right-handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vall d'Hebron Research Institute

Barcelona, 08035, Spain

Location

Related Publications (4)

  • 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.

    PMID: 25557693BACKGROUND

  • Liu 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.

    PMID: 23874543BACKGROUND

  • Zeng 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.

    PMID: 21684280BACKGROUND

  • Van 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.

    PMID: 20160711BACKGROUND

MeSH Terms

Conditions

Dyspepsia

Interventions

Fruit and Vegetable Juices

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2015

First Posted

October 30, 2015

Study Start

November 1, 2014

Primary Completion

June 1, 2017

Study Completion

June 30, 2017

Last Updated

July 27, 2017

Record last verified: 2016-09

Locations

ES(1)