Pilot Study of the Effect of Fructans on Fermentation in the Colon & Transit (PERFECT)
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|ClinicalTrials.gov Identifier: NCT01963364|
Recruitment Status : Completed
First Posted : October 16, 2013
Last Update Posted : January 17, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Evidence of Adaptation to Dietary Exposure to Fructans||Dietary Supplement: Inulin challenge Dietary Supplement: oligofructose supplement||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official 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|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
Experimental: Intervention group
All healthy volunteers
Dietary Supplement: Inulin challenge
On two study days one week apart, fasted participants will consume 500ml of water, flavoured with lime juice, containing 40g inulin.
Other Name: Orafti HP (Beneo-Orafti, Belgium)
Dietary Supplement: oligofructose supplement
Starting at the end of study day 1, consumption of 5 grams oligofructose coloured with carmine red food dye(<5%), dissolved in a hot drink, twice daily for 6 1/2 days/ 13 doses. The 14th dose of the week is the inulin challenge consumed as part of study day 1.
Other Name: Orafti P95 (Beneo-Orafti P95, Belgium)
- Change in whole gut transit time after one week (measured in hours) calculated using MRI marker capsule technique [ Time Frame: Difference (Delta) between baseline and after one week of intervention ]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.
- Change in fasting colonic volume [ Time Frame: Baseline and after one week of intervention ]Calculated from segmentation on MRI scans
- Change in colonic volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres [ Time Frame: Baseline and after one week of intervention ]Calculated from segmentation on MRI scans
- Change in fasting colonic gas volume, measured in millilitres [ Time Frame: Baseline and after one week of intervention ]Measured using MRI segmentation technique
- Change in colonic gas volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres [ Time Frame: Baseline and after one week of intervention ]Calculated from segmentation on MRI scans
- Change in breath hydrogen concentration, measured in parts per million before, 4 hours after, and 8 hours after ingestion of 40 grams inulin [ Time Frame: Baseline and after one week of intervention ]
- Change in faecal 5-HIAA concentration in μmol/g [ Time Frame: baseline and after one week of intervention ]measured by high performance liquid chromatography
- Presence of clinically important digestive symptoms during study day or intervention week [ Time Frame: one week of intervention ]
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01963364
|Sir Peter Mansfield Magnetic Resonance Centre|
|Nottingham, United Kingdom, NG7 2RD|
|Nottingham Digestive Diseases Centre|
|Nottingham, United Kingdom, NG7 2UH|
|Principal Investigator:||Robin C Spiller, MD||University of Nottingham|
|Principal Investigator:||Giles Major, MD||University of Nottingham|
|Principal Investigator:||Luca Marciani, PhD||University of Nottingham|