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Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake

Primary Purpose

Crohn's Disease

Status

Completed

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Dodecanoate acid and saline

About this trial

This is an interventional basic science trial for Crohn's Disease focused on measuring Crohn's Disease, gut brain axis, reduced appetite

Eligibility Criteria

16 Years - 75 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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
C-Reactive protein >5mg/dl
Harvey-Bradshaw index score of 5-16
Body mass index (BMI) 18-35
As for HV participants, inclusion criteria 1 and 7 will apply.

Exclusion Criteria:

Malignant disease
BMI <18 and >35
Significant cardiovascular or respiratory disease
Diabetes mellitus
Current Infection
Neurological or cognitive impairment; significant physical disability
Significant hepatic disease or renal failure
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)
Subjects currently participating in (or in the last three months) any other research project
pregnancy or breastfeeding or
if MRI is contraindicated (e.g. pacemaker).
Severe Crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable.
As for healthy volunteer participants all exclusion criteria apart from no.12.

Sites / Locations

University of Nottingham
University of Nottingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Crohn's Disease

Healthy

Arm Description

Active Crohn's Disease

Healthy volunteers

Outcomes

Primary Outcome Measures

Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls

Secondary Outcome Measures

Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal.

The increase or decrease in BOLD signal of the brain following the fatty acid stimuli will be correlated to the gut peptide levels which are listed as follows: CCK (pmol/ml) GLP-1 (pM) PYY (pg/ml) Ghrelin (ng/ml)

Full Information

NCT ID

NCT02772458

First Posted

February 11, 2016

Last Updated

April 16, 2019

Sponsor

University of Nottingham

1. Study Identification

Unique Protocol Identification Number

NCT02772458

Brief Title

Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake

Official Title

Reduced Appetite in Crohn's Disease: Investigating the Role of the Gut Brain Pathways

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Completed

Study Start Date

June 2015 (undefined)

Primary Completion Date

September 2018 (Actual)

Study Completion Date

September 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Nottingham

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood. Loss of appetite and symptoms such as tummy aches and bloating are common causes for weight loss in this group of patients. This problem has a strong negative effect on the patients' quality of life and significantly increases the cost of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the brain to control food intake. Recent evidence has showed that these cells increase in number in active CD and secrete more hormones that negatively affect appetite. The increased levels of these hormones should have an overall negative effect on the brain and thus decrease food intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are hypotheses that require further proof. Current technological advances in magnetic resonance imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain that control food intake. The involvement of the brain in control of food intake is still not fully understood. This work will be the first step in the right direction to start targeting the problems of appetite, weight loss and a poor quality of life.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn's Disease

Keywords

Crohn's Disease, gut brain axis, reduced appetite

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Participant

Allocation

Non-Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Crohn's Disease

Arm Type

Experimental

Arm Description

Active Crohn's Disease

Arm Title

Healthy

Arm Type

Experimental

Arm Description

Healthy volunteers

Intervention Type

Other

Intervention Name(s)

Dodecanoate acid and saline

Intervention Description

Test drink

Primary Outcome Measure Information:

Title

Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls

Time Frame

3 years

Secondary Outcome Measure Information:

Title

Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal.

Description

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

16 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 C-Reactive protein >5mg/dl Harvey-Bradshaw index score of 5-16 Body mass index (BMI) 18-35 As for HV participants, inclusion criteria 1 and 7 will apply. Exclusion Criteria: Malignant disease BMI <18 and >35 Significant cardiovascular or respiratory disease Diabetes mellitus Current Infection Neurological or cognitive impairment; significant physical disability Significant hepatic disease or renal failure 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) Subjects currently participating in (or in the last three months) any other research project pregnancy or breastfeeding or if MRI is contraindicated (e.g. pacemaker). Severe Crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable. As for healthy volunteer participants all exclusion criteria apart from no.12.

Facility Information:

Facility Name

University of Nottingham

City

Nottingham

ZIP/Postal Code

NG7 2RD

Country

United Kingdom

Facility Name

University of Nottingham

City

Nottingham

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

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Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake

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