Evidence of Adaptation to Dietary Exposure to Fructans Clinical Trial
— PERFECTOfficial title:
A Pilot Study Using Magnetic Resonance Imaging to Measure the Effect of Dietary Supplementation With Fructans on Whole Gut Transit Time, Colonic Gas Volume, and Volume Change in Response to a Fructan Challenge
| Verified date | January 2014 |
| Source | University of Nottingham |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United Kingdom: Research Councils UK |
| Study type | Interventional |
Some carbohydrates (complex sugars) which are found in grains, fruit and vegetables, cannot
be digested by humans. When eaten they pass through the small bowel to the large bowel, or
colon. Some bacteria that live in the colon are able to digest these carbohydrates, and use
them as an energy source. This releases energy that humans can absorb, and may have other
effects on health as well. The process also releases gases such as hydrogen and methane into
the colon, which will eventually be released as flatulence.
There is some evidence in animals, and humans, that changing the carbohydrate content of the
diet may increase the numbers of bacteria in the colon that can use this energy source.
Recent work has looked at how changes in colon bacteria and carbohydrate in the diet affect
transit, the speed at which food and stool moves through the stomach and bowels. This
undergraduate project will use techniques in Magnetic Resonance Imaging developed in
Nottingham to investigate how a prolonged change in dietary carbohydrate might affect speed
of transit through the bowel and gas production in the colon, and whether there is any
evidence of a change in the level of signalling chemicals that may affect bowel function.
| Status | Completed |
| Enrollment | 16 |
| Est. completion date | December 2013 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 55 Years |
| Eligibility |
Inclusion Criteria: - Aged 18-55 - Able to give informed consent - Does not meet criteria for diagnosis of IBS on Rome III questionnaire Exclusion Criteria: - Unable to abstain from smoking for the duration of the study (may affect breath hydrogen readings) - Self-declared vegetarian, vegan or kosher/ halal diet who cannot eat carmine red dye - Pregnancy declared by candidate - Female patients during their menstrual period - History declared by the candidate of pre-existing gastrointestinal disorder, including but not limited to: - Inflammatory Bowel Disease - Coeliac Disease - Pancreatitis - Gallstone disease (biliary colic, cholecystitis) - Diverticulitis - Cancer of the gastrointestinal tract - Irritable Bowel Syndrome - Reported history of previous resection of any part of the gastrointestinal tract other than appendix or gallbladder - Intestinal stoma - Any medical condition making participation potentially compromising participation in the study e.g. diabetes mellitus, respiratory disease limiting ability to lie in the scanner - Contraindications for MRI scanning i.e. metallic implants, pacemakers, history of metallic foreign body in eye(s) and penetrating eye injury - Reported alcohol dependence - Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists during or in the 2 weeks prior to the test. (Selective serotonin reuptake inhibitors and low dose tricyclic antidepressants will be recorded but will not be an exclusion criteria) - Antibiotic or probiotic treatment in the past 4 weeks - Inability to lie flat or exceed scanner limits of weight <120kg - Poor understanding of English language - Participation in night shift work the week prior to the study day. Night work is defined as working between midnight and 6.00 AM - Strenuous exercise greater than 10 hours per week (i.e. no competition training the week prior to the study). - Participation in any medical trials for the past 3 months - Anyone who in the opinion of the investigator is unlikely to be able to comply with the protocol e.g. cognitive dysfunction, chaotic lifestyle related to substance abuse |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Nottingham Digestive Diseases Centre | Nottingham | |
| United Kingdom | Sir Peter Mansfield Magnetic Resonance Centre | Nottingham |
| Lead Sponsor | Collaborator |
|---|---|
| University of Nottingham |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Presence of clinically important digestive symptoms during study day or intervention week | We will measure 4 symptoms from a previously validated questionnaire on a scale of 0 (none), 1 (mild/ distinct but negligible), 2 (moderate/ annoying), 3 (severe/ disabling), and also on a Visual Analogue Scale (0-100) Symptoms include abdominal pain, bloating, gas/flatulence, and diarrhoea. We will define clinically important symptoms as a composite score of 3 or more at any time point or on any day. |
one week of intervention | Yes |
| Primary | Change in whole gut transit time after one week (measured in hours) calculated using MRI marker capsule technique | 5 markers pills will be swallowed 24 hours before MRI scanning. Each pill will be given a score 0-9 based on the colonic segment where it is located. The weighted mean of these scores will be the geometric centre. Previous validation allows a transit time to be calculated from the geometric centre. | Difference (Delta) between baseline and after one week of intervention | No |
| Secondary | Change in fasting colonic volume | Calculated from segmentation on MRI scans | Baseline and after one week of intervention | No |
| Secondary | Change in colonic volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres | Calculated from segmentation on MRI scans | Baseline and after one week of intervention | No |
| Secondary | Change in fasting colonic gas volume, measured in millilitres | Measured using MRI segmentation technique | Baseline and after one week of intervention | No |
| Secondary | Change in colonic gas volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres | Calculated from segmentation on MRI scans | Baseline and after one week of intervention | No |
| Secondary | Change in breath hydrogen concentration, measured in parts per million before, 4 hours after, and 8 hours after ingestion of 40 grams inulin | Baseline and after one week of intervention | No | |
| Secondary | Change in faecal 5-HIAA concentration in µmol/g | measured by high performance liquid chromatography | baseline and after one week of intervention | No |