Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake
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ClinicalTrials.gov Identifier: NCT02772458 |
Recruitment Status :
Completed
First Posted : May 13, 2016
Last Update Posted : April 17, 2019
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Other: Dodecanoate acid and saline | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Non-Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Basic Science |
Official Title: | Reduced Appetite in Crohn's Disease: Investigating the Role of the Gut Brain Pathways |
Study Start Date : | June 2015 |
Actual Primary Completion Date : | September 2018 |
Actual Study Completion Date : | September 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Crohn's Disease
Active Crohn's Disease
|
Other: Dodecanoate acid and saline
Test drink |
Experimental: Healthy
Healthy volunteers
|
Other: Dodecanoate acid and saline
Test drink |
- 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 ]
- Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal. [ Time Frame: 3 years ]
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)

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Ages Eligible for Study: | 16 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772458
United Kingdom | |
University of Nottingham | |
Nottingham, United Kingdom, NG7 2RD | |
University of Nottingham | |
Nottingham, United Kingdom |
Responsible Party: | University of Nottingham |
ClinicalTrials.gov Identifier: | NCT02772458 |
Other Study ID Numbers: |
14038 |
First Posted: | May 13, 2016 Key Record Dates |
Last Update Posted: | April 17, 2019 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Crohn's Disease gut brain axis reduced appetite |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |