Pilot Study of the Effect of Fructans on Fermentation in the Colon & Transit (PERFECT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01963364
First received: October 8, 2013
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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 Intervention
Evidence of Adaptation to Dietary Exposure to Fructans
Dietary Supplement: Inulin challenge
Dietary Supplement: oligofructose supplement

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in fasting colonic volume [ Time Frame: Baseline and after one week of intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Calculated from segmentation on MRI scans

  • Change in fasting colonic gas volume, measured in millilitres [ Time Frame: Baseline and after one week of intervention ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Change in faecal 5-HIAA concentration in μmol/g [ Time Frame: baseline and after one week of intervention ] [ Designated as safety issue: No ]
    measured by high performance liquid chromatography


Other Outcome Measures:
  • Presence of clinically important digestive symptoms during study day or intervention week [ Time Frame: one week of intervention ] [ Designated as safety issue: Yes ]
    • 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.


Enrollment: 16
Study Start Date: October 2013
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01963364

Locations
United Kingdom
Nottingham Digestive Diseases Centre
Nottingham, United Kingdom, NG7 2UH
Sir Peter Mansfield Magnetic Resonance Centre
Nottingham, United Kingdom, NG7 2RD
Sponsors and Collaborators
University of Nottingham
Investigators
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
  More Information

Additional Information:
No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01963364     History of Changes
Other Study ID Numbers: 11072013SCSMRI
Study First Received: October 8, 2013
Last Updated: January 16, 2014
Health Authority: United Kingdom: Research Councils UK

Keywords provided by University of Nottingham:
fructans
inulin
oligofructose
colonic fermentation
microbiota
whoe gut transit

Additional relevant MeSH terms:
Levan
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014