Smell&Crohn: Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease

Sponsor
Centre Hospitalier Universitaire Dijon (Other)
Overall Status
Recruiting
CT.gov ID
NCT02859675
Collaborator
(none)
75
1
121.8
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Study Details

Study Description

Brief Summary

This study will improve our understanding of the mechanisms underlying anorexia in persons with Crohn's disease flare-ups. The practical spin-off from this research is potentially very important for the management of nutritional disorders associated with the disease by guiding diets towards foods that correspond to patients' preferences and/or to modified tastes. In addition, the results could lead to the identification of sensory markers that herald an inflammatory flare-up of the disease.

Condition or Disease Intervention/Treatment Phase
  • Other: triangular test
  • Biological: blood sampling
  • Other: Questionnaires

Study Design

Study Type:
Observational
Anticipated Enrollment :
75 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Olfactogustatory Perception, Eating Behaviour and Inflammation in Crohn's Disease
Actual Study Start Date :
Oct 7, 2013
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Crohn and anti-TNF treatment

Tests at 3 or 4 weeks after the beginning of anti-TNF treatment

Other: triangular test
metabolic state, impedance measurement, potential flavours evoked by sucrose,

Biological: blood sampling
sampling of 2 mL

Other: Questionnaires
Stunkard, PrefQuest

Crohn and without anti-TNF treatment

tests performed according to patient availability

Other: triangular test
metabolic state, impedance measurement, potential flavours evoked by sucrose,

Biological: blood sampling
sampling of 2 mL

Other: Questionnaires
Stunkard, PrefQuest

Control

tests performed according to patient availability

Other: triangular test
metabolic state, impedance measurement, potential flavours evoked by sucrose,

Biological: blood sampling
sampling of 2 mL

Other: Questionnaires
Stunkard, PrefQuest

Outcome Measures

Primary Outcome Measures

  1. Modification of sweet taste [through the study completion up to 10 years]

    the measurement of detection thresholds consists in presenting to the participants in order of increasing concentrations, series of forced-choice triangular tests

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
For patients :
Inclusion Criteria:
  • Age between 18 and 60 years,

  • Diagnosis of Crohn's disease according to clinical, endoscopic, histological, radiological and biochemical criteria as defined by the European Consensus Conference,

  • Men or women who have provided consent and willing to cooperate.

Exclusion Criteria:
  • Chronic inflammatory intestinal disease (CIID) other than Crohn's disease: haemorrhagic rectocolitis, undetermined colitis, microscopic colitis.

  • Intercurrent disease (diabetes and metabolic disease, liver cirrhosis, progressive cancer, acute or chronic infection, Human Immunodeficiency Virus HIV),

  • Organ failure (respiratory, heart, or renal failure, neurological disorders),

  • Intolerance to gluten,

  • Treatments (other than those used for Crohn's disease) able to interfere with food intake,

  • Aversion to foods consumed or smelled,

  • Poor understanding of cognitive tasks required.

  • Crohn's disease complicated by an abscess or infectious complication

  • Acute Crohn's disease defined by a CDAI score > 150

For Controls:
Inclusion Criteria:
  • Adult person

  • Without follow-up for a chronic pathology

  • Having given its consent

Exclusion Criteria:
  • Protected adult

  • Person not affiliated to a social security system

  • Pregnant or breastfeeding woman

  • Active smoker

  • No one who does not speak French

  • Taking treatment that interferes with taste or acts on the central nervous system

Contacts and Locations

Locations

Site City State Country Postal Code
1 Centre Hospitalier Universitaire Dijon France 21079

Sponsors and Collaborators

  • Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier:
NCT02859675
Other Study ID Numbers:
  • BRONDEL Ass INRA 2011
First Posted:
Aug 9, 2016
Last Update Posted:
Aug 15, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 15, 2019