Eating Behaviour in Crohn's Disease

NCT02379117 | Completed Results DMC

• 1 other identifier: 15005
• Study Type: observational
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

Food intake is mainly controlled through interactions between the gut and brain (the homeostatic control) and through our environment, with food exposure, mood and past experiences (the hedonic control) playing a major role. The link between the gut and the brain is mainly controlled through enteroendocrine cells (EC). These cells in the bowel sense nutrients in the food and link with the brain to control how much we eat. They make a number of hormones that link with the brain to control one's eating habits. Crohn's disease (CD) is an inflammatory disease of the bowel which can present with a number of symptoms including weight loss and loss of appetite. We thought some time ago that an increase in the number and function of these EC could play a central role. Since then we have carried out work which has shown that in CD these EC increase in number and produce more hormones after a meal. This finding could have a negative effect on food intake. This would be one explanation to the symptoms so commonly experienced by these patients. In CD we thus feel that there might be an imbalance in the appetite control. We expect an increasingly sensitive gut to food intake and a subdued mood and perception to food reward and that this imbalance will lead to a decrease in food reward and consequently a decrease in food intake. This study will be carried out using Healthy Volunteers and CD patients. We plan to measure food intake though telephone interviews and plan to analyse eating behaviour through 5 questionnaires.This study will help us to improve our understanding of what it is that controls food intake. This will be particularly important to patients with CD who routinely lose weight and appetite.

Conditions

Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Dietary Recalls (Calorific Intake)

  The primary endpoints for this study will be food intake as measured by one telephone-administered 24-h dietary recall. Total calorific intake will be calculated.

  Participants will be included in this study for 1 week

Secondary Outcomes (5)

• Three Factor Eating Questionnaire (TFEQ) Restraint, Disinhibition and Hunger Subscales

  Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.

• The Binge Eating Scale

  Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.

• The Power of Food Scale

  Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.

• The Dutch Eating Behaviour Questionnaire

  Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.

• The Control of Eating Questionnaire

  Healthy volunteer participants will be included in this study for 1 week. Crohn's Disease participants will be included in the study until they are re-assessed in remission. A time limit of 12 months will be given.

Study Arms (2)

Crohn's Disease Patients

Patients with a diagnosis of Crohn's disease fitting the studies inclusion \& exclusion criteria.

Healthy Volunteers

For healthy volunteers the studies exclusion criteria apply.

Eligibility Criteria

• Age: 16 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Recruitment The chief investigator is a specialist in Inflammatory Bowel disease and also an associate professor of gastroenterology at the University of Nottingham and Nottingham University Hospital which is a tertiary-level care academic institution covering a population of approximately 1 million people for secondary-level care and 4.5 million people for tertiary-level care. Collectively we manage approximately 4000 IBD patients. Participants shall be recruited from two sources: 1. Crohn's Disease patients from clinic. 2. Crohns Disease patients and Healthy Volunteers via the study flyer and social media.

You may qualify if:

• We will study a cohort of CD patients with active disease as defined by:
• Age 16-75 years
• Ulceration seen at ileocolonoscopy, aiming for a simple endoscopic score for Crohn's disease (SES-CD) of 4-19, in the absence of stricturing disease or,
• Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or
• Faecal calprotectin of \>250µg/g or
• C-Reactive protein \>5mg/dl or,
• Harvey-Bradshaw index score of 5-16
• Body mass index (BMI) of 18-30.

You may not qualify if:

• Present or recent (within 12 weeks) corticosteroid usage
• Malignant disease
• BMI \<18 or \>30.
• Significant cardiovascular or respiratory disease
• Diabetes mellitus
• Current Infection
• Neurological or cognitive impairment; significant physical disability
• Significant hepatic disease or renal failure
• Subjects currently participating in (or in the last three months) any other research project
• pregnancy or breastfeeding or
• Severe CD where a delay in a change in medical treatment for 1 weeks would not be clinically advisable

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Queens Medical Centre

Nottingham, Nottinghamshire, NG7 2UH, United Kingdom

Location

Related Publications (13)

• Bryant RV, Trott MJ, Bartholomeusz FD, Andrews JM. Systematic review: body composition in adults with inflammatory bowel disease. Aliment Pharmacol Ther. 2013 Aug;38(3):213-25. doi: 10.1111/apt.12372. Epub 2013 Jun 14.

  PMID: 23763279 RESULT

• Lochs H, Dejong C, Hammarqvist F, Hebuterne X, Leon-Sanz M, Schutz T, van Gemert W, van Gossum A, Valentini L; DGEM (German Society for Nutritional Medicine); Lubke H, Bischoff S, Engelmann N, Thul P; ESPEN (European Society for Parenteral and Enteral Nutrition). ESPEN Guidelines on Enteral Nutrition: Gastroenterology. Clin Nutr. 2006 Apr;25(2):260-74. doi: 10.1016/j.clnu.2006.01.007. Epub 2006 May 15.

  PMID: 16698129 RESULT

• Moran GW, Leslie FC, McLaughlin JT. Crohn's disease affecting the small bowel is associated with reduced appetite and elevated levels of circulating gut peptides. Clin Nutr. 2013 Jun;32(3):404-11. doi: 10.1016/j.clnu.2012.08.024. Epub 2012 Sep 3.

  PMID: 22999064 RESULT

• Moran GW, Pennock J, McLaughlin JT. Enteroendocrine cells in terminal ileal Crohn's disease. J Crohns Colitis. 2012 Oct;6(9):871-80. doi: 10.1016/j.crohns.2012.01.013. Epub 2012 Mar 3.

  PMID: 22398079 RESULT

• Moran GW, McLaughlin JT. Plasma chromogranin A in patients with inflammatory bowel disease: a possible explanation. Inflamm Bowel Dis. 2010 Jun;16(6):914-5. doi: 10.1002/ibd.21096. No abstract available.

  PMID: 19760780 RESULT

• Keller J, Beglinger C, Holst JJ, Andresen V, Layer P. Mechanisms of gastric emptying disturbances in chronic and acute inflammation of the distal gastrointestinal tract. Am J Physiol Gastrointest Liver Physiol. 2009 Nov;297(5):G861-8. doi: 10.1152/ajpgi.00145.2009.

  PMID: 20501434 RESULT

• Moran GW, O'Neill C, Padfield P, McLaughlin JT. Dipeptidyl peptidase-4 expression is reduced in Crohn's disease. Regul Pept. 2012 Aug 20;177(1-3):40-5. doi: 10.1016/j.regpep.2012.04.006. Epub 2012 May 2.

  PMID: 22561447 RESULT

• Lassman DJ, McKie S, Gregory LJ, Lal S, D'Amato M, Steele I, Varro A, Dockray GJ, Williams SC, Thompson DG. Defining the role of cholecystokinin in the lipid-induced human brain activation matrix. Gastroenterology. 2010 Apr;138(4):1514-24. doi: 10.1053/j.gastro.2009.12.060. Epub 2010 Jan 18.

  PMID: 20080096 RESULT

• Smeets PA, de Graaf C, Stafleu A, van Osch MJ, van der Grond J. Functional magnetic resonance imaging of human hypothalamic responses to sweet taste and calories. Am J Clin Nutr. 2005 Nov;82(5):1011-6. doi: 10.1093/ajcn/82.5.1011.

  PMID: 16280432 RESULT

• Pannacciulli N, Le DS, Salbe AD, Chen K, Reiman EM, Tataranni PA, Krakoff J. Postprandial glucagon-like peptide-1 (GLP-1) response is positively associated with changes in neuronal activity of brain areas implicated in satiety and food intake regulation in humans. Neuroimage. 2007 Apr 1;35(2):511-7. doi: 10.1016/j.neuroimage.2006.12.035. Epub 2007 Jan 18.

  PMID: 17317222 RESULT

• Batterham RL, ffytche DH, Rosenthal JM, Zelaya FO, Barker GJ, Withers DJ, Williams SC. PYY modulation of cortical and hypothalamic brain areas predicts feeding behaviour in humans. Nature. 2007 Nov 1;450(7166):106-9. doi: 10.1038/nature06212. Epub 2007 Oct 14.

  PMID: 17934448 RESULT

• De Silva A, Salem V, Long CJ, Makwana A, Newbould RD, Rabiner EA, Ghatei MA, Bloom SR, Matthews PM, Beaver JD, Dhillo WS. The gut hormones PYY 3-36 and GLP-1 7-36 amide reduce food intake and modulate brain activity in appetite centers in humans. Cell Metab. 2011 Nov 2;14(5):700-6. doi: 10.1016/j.cmet.2011.09.010. Epub 2011 Oct 13.

  PMID: 22000927 RESULT

• Scholtz S, Miras AD, Chhina N, Prechtl CG, Sleeth ML, Daud NM, Ismail NA, Durighel G, Ahmed AR, Olbers T, Vincent RP, Alaghband-Zadeh J, Ghatei MA, Waldman AD, Frost GS, Bell JD, le Roux CW, Goldstone AP. Obese patients after gastric bypass surgery have lower brain-hedonic responses to food than after gastric banding. Gut. 2014 Jun;63(6):891-902. doi: 10.1136/gutjnl-2013-305008. Epub 2013 Aug 20.

  PMID: 23964100 RESULT

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Results Point of Contact

• Title: Dr Gordon Moran
• Organization: UNottingham

Gordon.Moran@nottingham.ac.uk

44 [0]115 9249924

Study Officials

• Gordon W Moran

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2015
• First Posted: March 4, 2015
• Study Start: April 1, 2015
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: July 15, 2019
• Results First Posted: July 15, 2019

Record last verified: 2019-04

Locations

GB (1)