The Effect of the Low FODMAP Diet and Dietary Oligofructose on Gastrointestinal Form, Function and Microbiota

NCT02259465 | Completed

• 1 other identifier: SoM A14082014 FOG
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

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 immune reaction to the carbohydrate from the bowel wall.

Conditions

Irritable Bowel Syndrome

Keywords

microbiota; FODMAP; oligofructose; Magnetic Resonance Imaging; Metabolomics; Diet

Outcome Measures

Primary Outcomes (1)

• Change in colonic volume

  Percentage change from baseline in fasting colonic volume after one week of intervention, as measured by Magnetic Resonance Imaging (MRI)

  one week

Secondary Outcomes (4)

• Change in whole gut transit time

  one week

• Change in colonic gas volume

  one week

• Change in fasting breath hydrogen

  one week

• Change in fasting breath methane

  one week

Other Outcomes (3)

• Change in urinary metabolites

  one week

• Change in faecal microbiota

  one week

• Change in faecal short-chain fatty acids

  one week

Study Arms (2)

Oligofructose

ACTIVE COMPARATOR

Participants will be asked to follow the low FODMAP diet for a week, supplementing the diet with oligofructose, 7grams twice daily

Behavioral: low FODMAP diet; Dietary Supplement: Oligofructose

Maltodextrin

PLACEBO COMPARATOR

Participants will be asked to follow the low FODMAP diet for a week, supplementing the diet with maltodextrin, 7grams twice daily

Behavioral: low FODMAP diet; Dietary Supplement: Maltodextrin

Interventions

low FODMAP diet BEHAVIORAL

Participants will attend a one-hour group session on how to follow the low FODMAP diet, run by a dietitian trained in the diet. They will be asked to follow the diet for 7 days while keeping a food diary.

Maltodextrin; Oligofructose

Oligofructose DIETARY_SUPPLEMENT

Participants will supplement their diet with 7 grams of OF twice daily for the week that they follow the low FODMAP diet.

Also known as: OraftiP95, OF

Oligofructose

Maltodextrin DIETARY_SUPPLEMENT

Participants will supplement their diet with 7 grams of maltodextrin twice daily for the week that they follow the low FODMAP diet.

Maltodextrin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Aged 18 or older
• Able to give informed consent

You may not qualify if:

• Self-declared vegetarian, vegan or kosher/ halal diet who cannot eat carmine red dye
• Pregnancy declared by candidate
• History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function
• A positive diagnosis of irritable bowel syndrome based on the Rome III criteria questionnaire
• Reported history of previous resection of the oesophagus, stomach or intestine (excluding appendix)
• 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
• Will not limit alcohol intake to ≤ 35 units/ week and ≤ 8 units per day during trial
• Antibiotic or prescribed probiotic treatment in the past 8 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
• 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

Sponsors & Collaborators

• University of Nottingham: lead
• King's College London: collaborator

Study Sites (1)

Nottingham Digestive Diseases Centre

Nottingham, NG7 2UH, United Kingdom

Location

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Irritable Bowel Syndrome

Interventions

FODMAP Diet; oligofructose; maltodextrin

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Elimination Diets; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Robin C Spiller, MD FRCP

  University of Nottingham

  STUDY CHAIR

• Giles AD Major, BMBCh MRCP

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 8, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: March 18, 2015

Record last verified: 2015-03

Locations

GB (1)