Eating Behaviour in Crohn's Disease

• Sponsor: University of Nottingham (Other)
• Overall Status: Completed
• CT.gov ID: NCT02379117
• Collaborator: (none)
• Enrollment: 61
• Location: 1
• Duration (Months): 33.1
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Crohn's Disease

Detailed Description

STUDY BACKGROUND INFORMATION AND RATIONALE

Crohn's disease (CD) patients can present with a variety of luminal and extra-luminal symptoms but nutritional abnormalities are a very common but poorly studied [1] problem in this disease [2]. Apart from disease burden and repeated surgery, reduced appetite [3] and associated symptoms such as nausea undoubtedly contribute, with a major impact on quality of life.

Appetite and satiation, the processes by which a meal is terminated, involve complex interactions of homeostatic and hedonic factors. While the hypothalamus is central in the homeostatic control of food intake, other neural circuits integrate environmental and emotional cues to constitute the hedonic drive of appetite regulation. The homeostatic control of food intake is governed by the enteroendocrine-gut brain axis. Enteroendocrine cells (EC) play a pivotal role in orchestrating physiological functions in the gastrointestinal (GI) tract. Sensing the nutrient content of the lumen, they secrete multiple peptides and amines that control gut secretory and motor functions. Gut hormones act on vagal afferents in the GI tract, directly relaying to key central nervous system (CNS) nuclei that interface within the hypothalamus and other cortical areas to regulate food intake. CD patients with active small bowel inflammation show significant up-regulation of EC cells with an increase in ileal expression of chromogranin A [4, 5], glucagon-like peptide-1 (GLP-1) [4], key transcription factors in the stem cell to EC differentiation pathway [4] , plasma polypeptide YY (PYY) [3], cholecystokinin (CCK) [6] levels and a reduction in the key enzyme dipeptidyl peptidase-4 expression [7]. This increase in plasma peptide levels is associated with the symptoms of nausea and anorexia, with both symptoms, and tissue and plasma EC-peptide expression decreasing to normality in remission [3].

An increase in EC expression at the tissue and plasma level might affect appetite regulation through an increase in CNS signalling.

Fatty-acids infused in the gut, lead to a CCK-dependent increase in CNS activity in areas related to homeostatic control of feeding such as the brainstem, the pons, hypothalamus, cerebellum and the motor cortical areas [8]. Glucose has been shown to decrease the response in the upper hypothalamus [9], possibly via a GLP-1-mediated pathway [10]. Ghrelin and PYY have known homeostatic CNS signalling properties but play a hedonic role in the control of food intake [11]. In effect, the increase in plasma PYY and GLP-1 seen after Roux-en-Y gastric bypass surgery in obese subjects or after parenteral administration [12] is associated with a lower activation in brain-hedonic food responses and a healthier eating behaviour [13]. In CD, we expect a subdued reward value of food, but postulate that this would be aversive, and inappropriately impairing appetite and food intake.

We hypothesize that in CD and small bowel inflammation we will observe a change in eating behaviour with loss of hedonic drives and food reward responses and an accentuated homeostatic response.

STUDY OBJECTIVES AND PURPOSE

PURPOSE The overall purpose of the study is to quantify food intake in patients with active Crohn's disease and compare it to when they are in remission and to healthy age, BMI and gender-matched healthy cohort of volunteers. We will quantify eating behaviour traits in the same patient cohort when in active disease and repeat when in remission. These data will be compared to that of healthy volunteers.

PRIMARY OBJECTIVE The primary objective is to quantify food intake in patients with active CD and compare this to HV.

SECONDARY OBJECTIVES The secondary objectives of this study are to a) quantify food intake in patients with active CD and compare that when in inactive disease. b) quantify changes in appetite and eating behaviour in patients with active CD and compare these to those in HV and inactive CD as measured by the appetite-related questionnaires

Study Design

• Study Type: Observational
• Actual Enrollment: 61 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Eating Behaviour in Crohn's Disease
• Study Start Date: Apr 1, 2015
• Actual Primary Completion Date: Jan 1, 2018
• Actual Study Completion Date: Jan 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Dietary Recalls (Calorific Intake) [Participants will be included in this study for 1 week]

   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.

Secondary Outcome Measures

1. 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 TFEQ contains 51 items and measures three dimensions of human eating behaviour: Cognitive Restraint of Eating [I], Disinhibition [II], and Hunger [III]. Each item scores either 0 or 1 point. The minimum score for factors I, II. and III is therefore 0, with the pos- sible maximum scores being 21, 16, and 14 respectively. High scores mean worse outcome.

2. 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 BES is a 16-item questionnaire that assesses the severity of binge eating tendencies. Eight questions describe the behavioural mani- festations of binge eating behaviour and eight describe the feelings and cognitions associated with binge eating. Scores are summed to produce a total score ranging from 0 to 46. Cut-off points have previously been reported denoting mild [≤17], moderate [18-26], and severe [≥27] binge eating behaviours. High score means worse outcome

3. 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 PFS is a 15-item questionnaire reflecting the psychological influence of the food environment. It measures appetite for, rather than consumption of, palatable foods and may be a useful measure of the hedonic impact of food environments replete with highly palatable foods. Items are grouped into three domains according to food proximity; food available but not physically present; food present but not tasted; and food tasted but not consumed. High scores mean worse outcome

4. 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 33-item DEBQ assesses different eating styles that may contribute to weight gain: emotional eating, external eating, and restraint. 'Emotional eating' occurs in response to emotional arousal states such as fear, anger, or anxiety; 'external eating' occurs in response to external food cues such as sight and smell of food; and 'restraint eating' is overeating after a period of slimming when the cognitive resolve to diet is abandoned. High score means worse outcome

5. 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.]

   The CoEQ is a 21-item questionnaire designed to assess the severity and type of food cravings experienced over the previous 7 days. The CoEQ has four subscales: Craving Control, Craving for Savoury, Craving for Sweet, and Positive Mood. Items on the CoEQ are assessed by 100-mm visual analogue scales [VAS], with items relating to each subscale being averaged to create a final score. High positive mood is better outcome

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

We will study a cohort of CD patients with active disease as defined by:

1. Age 16-75 years

2. 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,

3. Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or

4. Faecal calprotectin of >250µg/g or

5. C-Reactive protein >5mg/dl or,

6. Harvey-Bradshaw index score of 5-16

7. Body mass index (BMI) of 18-30.

For HV participants, inclusion criteria's 1 and 7 apply.

Exclusion Criteria:

1. Present or recent (within 12 weeks) corticosteroid usage

2. Malignant disease

3. BMI <18 or >30.

4. Significant cardiovascular or respiratory disease

5. Diabetes mellitus

6. Current Infection

7. Neurological or cognitive impairment; significant physical disability

8. Significant hepatic disease or renal failure

9. Abnormal blood results other than those explained by CD including bleeding diatheses (apart from in the case of HV where all unexplained blood results are an exclusion criteria) ,

10. Subjects currently participating in (or in the last three months) any other research project

11. pregnancy or breastfeeding or

12. Severe CD where a delay in a change in medical treatment for 1 weeks would not be clinically advisable

For HV participants, all exclusion criteria apply with the exception of criteria no.12

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queens Medical Centre	Nottingham	Nottinghamshire	United Kingdom	NG7 2UH

Sponsors and Collaborators

• University of Nottingham

Investigators

• Principal Investigator: Gordon W Moran, University of Nottingham

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Feb 19, 2015

More Information

Publications

None provided.

• Responsible Party: University of Nottingham
• ClinicalTrials.gov Identifier: NCT02379117
• Other Study ID Numbers: 15005
• First Posted: Mar 4, 2015
• Last Update Posted: Jul 15, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Crohn Disease

Study Results

Participant Flow

Arm/Group Title	Crohn's Disease Patients	Healthy Volunteers
Arm/Group Description	Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.	For healthy volunteers the studies exclusion criteria apply.
Period Title: Overall Study
STARTED	30	31
COMPLETED	30	31
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Crohn's Disease Patients	Healthy Volunteers	Total
Arm/Group Description	Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.	For healthy volunteers the studies exclusion criteria apply.	Total of all reporting groups
Overall Participants	30	31	61
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	29 96.7%	31 100%	60 98.4%
>=65 years	1 3.3%	0 0%	1 1.6%
Age (years) [Mean (Inter-Quartile Range) ]
Mean (Inter-Quartile Range) [years]	32.3	32.8	32.5
Sex: Female, Male (Count of Participants)
Female	12 40%	12 38.7%	24 39.3%
Male	18 60%	19 61.3%	37 60.7%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United Kingdom	30 100%	31 100%	61 100%

Outcome Measures

1. Primary Outcome

Title	Dietary Recalls (Calorific Intake)
Description	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.
Time Frame	Participants will be included in this study for 1 week

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Crohn's Disease Patients	Healthy Volunteers
Arm/Group Description	Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.	For healthy volunteers the studies exclusion criteria apply.
Measure Participants	30	31
Mean (Standard Error) [kcal]	1900.9 (138.6)	2054.3 (110.7)

2. Secondary Outcome

Title	Three Factor Eating Questionnaire (TFEQ) Restraint, Disinhibition and Hunger Subscales
Description	The TFEQ contains 51 items and measures three dimensions of human eating behaviour: Cognitive Restraint of Eating [I], Disinhibition [II], and Hunger [III]. Each item scores either 0 or 1 point. The minimum score for factors I, II. and III is therefore 0, with the pos- sible maximum scores being 21, 16, and 14 respectively. High scores mean worse outcome.
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

3. Secondary Outcome

Title	The Binge Eating Scale
Description	The BES is a 16-item questionnaire that assesses the severity of binge eating tendencies. Eight questions describe the behavioural mani- festations of binge eating behaviour and eight describe the feelings and cognitions associated with binge eating. Scores are summed to produce a total score ranging from 0 to 46. Cut-off points have previously been reported denoting mild [≤17], moderate [18-26], and severe [≥27] binge eating behaviours. High score means worse outcome
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

4. Secondary Outcome

Title	The Power of Food Scale
Description	The PFS is a 15-item questionnaire reflecting the psychological influence of the food environment. It measures appetite for, rather than consumption of, palatable foods and may be a useful measure of the hedonic impact of food environments replete with highly palatable foods. Items are grouped into three domains according to food proximity; food available but not physically present; food present but not tasted; and food tasted but not consumed. High scores mean worse outcome
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

5. Secondary Outcome

Title	The Dutch Eating Behaviour Questionnaire
Description	The 33-item DEBQ assesses different eating styles that may contribute to weight gain: emotional eating, external eating, and restraint. 'Emotional eating' occurs in response to emotional arousal states such as fear, anger, or anxiety; 'external eating' occurs in response to external food cues such as sight and smell of food; and 'restraint eating' is overeating after a period of slimming when the cognitive resolve to diet is abandoned. High score means worse outcome
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

6. Secondary Outcome

Title	The Control of Eating Questionnaire
Description	The CoEQ is a 21-item questionnaire designed to assess the severity and type of food cravings experienced over the previous 7 days. The CoEQ has four subscales: Craving Control, Craving for Savoury, Craving for Sweet, and Positive Mood. Items on the CoEQ are assessed by 100-mm visual analogue scales [VAS], with items relating to each subscale being averaged to create a final score. High positive mood is better outcome
Time Frame	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title

Arm/Group Description

Adverse Events

Time Frame	2 years 7 months
Adverse Event Reporting Description	Observational study, Cross sectional study, adverse events not monitored/assessed
Arm/Group Title	Crohn's Disease Patients		Healthy Volunteers
Arm/Group Description	Patients with a diagnosis of Crohn's disease fitting the studies inclusion & exclusion criteria.		For healthy volunteers the studies exclusion criteria apply.
All Cause Mortality
	Crohn's Disease Patients		Healthy Volunteers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Serious Adverse Events
	Crohn's Disease Patients		Healthy Volunteers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Crohn's Disease Patients		Healthy Volunteers
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.