Effects of FODMAPs on Small Bowel Water Content: an MRI Study (FODMAPs)

December 18, 2012 updated by: University of Nottingham

Effects of FODMAPs (Fermentable Oligo-, Di-, and Mono-saccharides, And Polyols) on Small Bowel Water Content: an MRI Study

Some carbohydrates, particularly fructose, the sugar found in fruit and bread may cause bloating, pain and erratic bowel habits (diarrhoea and constipation) particularly in patients suffering from the irritable bowel syndrome (IBS). This may be because they are not well absorbed in the small intestine and cause water to be trapped in the bowel causing distension. Studies have shown that reducing the amount of these sugars in the diet can relieve these symptoms. There is some evidence that combining fructose and glucose can reduce the symptoms caused by fructose but just why is unclear. In this study, the investigators will use a non invasive medical imaging technique called "magnetic resonance imaging" (or MRI) to look at the behaviour of drinks containing these sugars in the bowels of healthy human volunteers.

The investigators will give four different drinks: one beverage consisting of a very well absorbed sugar, glucose, another consisting of the less well absorbed sugar fructose, a third which is a mixture of glucose and fructose, and a fourth consisting of several fructose subunits joined together (called fructan). The investigators will take MRI images of the stomach and intestines at intervals for 5 hours and compare these with the feelings of distension and bloating in our volunteers. The results will act as control for subsequent studies in IBS patients and these may help design diets to reduce symptoms in IBS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Title: Effects of FODMAPs (Fermentable Oligo-, Di-, and Mono-saccharides, And Polyols) on small bowel water content: an MRI study

  1. Background. FODMAPs consist of fructose, lactose, fructo- and galacto-oligosaccharides such as fructans and galactans, and polyols such as sorbitol and mannitol. These carbohydrates are poorly absorbed in the small intestine and have been shown to trigger symptoms of irritable bowel syndrome (IBS). Previous studies have shown that fructose malabsorption results in an increased osmotic load in the small bowel, which can have a laxative effect. Physical proof of this has only been obtained using an ileostomy model on patients. This study indicated increased small bowel water content (SBWC) but this has never been established in intact humans .). We have been using noninvasive magnetic resonance imaging (MRI) to provide novel insights on the fate of food materials within the gastro-intestinal tract (GIT) of humans for the last decade.
  2. Aims (to include hypothesis to be tested) This study aims to investigate whether fructose alone will increase SBWC compared to an equivalent mass of glucose, and if adding glucose to fructose will reduce its effect on the SBWC. The study also aims to determine if fructans alter colonic transit.The main hypothesis is that fructose will increase small bowel water while fructans will mainly affect colonic transit..
  3. Experimental protocol and methods. A single-centre, randomized, cross-over design study consisting of a screening visit and four test days, which will be approximately 1 week apart The subjects (18 healthy volunteers for main study plus 4 for pilot studies) will receive (according to a randomization schedule) each test day one out of four test products: 1) glucose (control) 2) fructose, 3) glucose with fructose and 4) fructans. On each test day, volunteers will have a baseline scan in a 1.5T scanner, consume one of the products instead of breakfast at 09:00 and will be imaged in the scanner at intervals for 5 hours using a range of MRI sequences.

All the tested ingredients are food grade, have a history of safe use at intended usage levels, and are regarded as safe.

Four test products will be evaluated:

  1. 500 mL of glucose (40g of glucose dissolved in water with pure lime juice as flavorant)
  2. 500 mL fructose (40g fructose dissolved in water with pure lime juice as flavorant)
  3. 500 mL of glucose with fructose (40g glucose and 40g fructose dissolved in water with pure lime juice as flavorant, 40 or 80 gm)
  4. 500 mL fructan (40g of 100% fructan (inulin) dissolved in water with pure lime juice as flavorant)

4. Measurable end points/statistical power of the study. Primary endpoint: small bowel water content area under the curve (AUC) -45 - 315 minutes. Secondary endpoint: gastric emptying T50, colonic volume as characterised by AUC -45 - 315 minutes of ascending colon, colonic motility, symptoms questionnaires, small bowel transit time, breath hydrogen concentrations and tryptase faecal content.

Previous work using mannitol and glucose indicates that mean (SD) SBWC at 40 minutes postprandial after ingesting 300ml glucose was 47 (SD 15) and using n=12 the investigators calculate the investigators can detect an increase of 20 ml in excess of this with 90% power which is very much less than the investigators are predicting. The investigators plan to use 18 to ensure the investigators can assess our secondary endpoints for which there is no data with which to perform a power calculation.

Study Type

Interventional

Enrollment (Actual)

17

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Nottinghamshire
      • Nottingham, Nottinghamshire, United Kingdom, NG72UH
        • NDDC BRU and Sir Peter Mansfield Magnetic Resonance Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Apparently healthy: no medical conditions which might effect study measurements.
  • No reported participation in another nutritional or biomedical trial 3 months before the pre-study examination or during the study.
  • Age ≥ 18 and ≤ 60 year at pre-study investigation.
  • Body mass index (BMI) ≥ 18.0 and ≤ 30.0 kg/m2
  • No reported participation in night shift work two days prior to pre-study investigation or during the study. Night work is defined as working between midnight and 6.00 AM.
  • Strenuous exercise ≤ 10 hours per week.
  • Gender: male or female
  • Consumption of ≤ 21 alcoholic drinks in a typical week
  • Currently not smoking
  • Suitable for MRI scanning (e.g., absence of metal implants, infusion pumps and pacemakers) as assessed by the attached MRI safety questionnaire.

Exclusion Criteria:

  • - use of medication which interferes with study measurements or bowel motility (as judged by the study physician).
  • Antibiotics in the 3 weeks before pre-study examination
  • Probiotics or during the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Glucose drink
Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g glucose
Dietary supplement: Glucose
500 ml water drink containing 40g glucose
Experimental: Fructose drink
Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose
Dietary supplement: Fructose
500 ml water drink containing 40g fructose
Experimental: Fructan drink
Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructan
Dietary supplement: Fructan
500 ml water drink containing 40g fructan
Experimental: Fructose and glucose drink
Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose and 40 g glucose
Dietary supplement: Fructose and glucose
500 ml water drink containing 40g fructose and 40g glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
small bowel water content area under the curve
Time Frame: -45 min to 315 min
Area Under the curve for small bowel water content, methods as Marciani, L., et al., Gastroenterology, 2010. 138(2): p. 469-U90. Hoad, C.L., et al.,. Physics in Medicine and Biology, 2007. 52(23): p. 6909-6922.
-45 min to 315 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
gastric emptying T50
Time Frame: -45 min to 315 min
time to half empty the stomach
-45 min to 315 min
ascending colon volume
Time Frame: -45 min to 315 min
AUC of the geometric volume of the ascending colon
-45 min to 315 min
ascending colon motility
Time Frame: -45 min to 315 min
motility index of the ascending colon as determined from dynamic MRI scan
-45 min to 315 min
symptoms questionnaires
Time Frame: -45 min to 315 min
bloating, nausea, gas belching and abdominal pain
-45 min to 315 min
bowel transit time
Time Frame: 24 hours
first time to detect sweetcorn markers in the stool
24 hours
fecal tryptase activity
Time Frame: 24 h
activity of stool triptase in trypsin units of activity
24 h

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Nottingham

Investigators

  • Principal Investigator: Robin C Spiller, MD FRCP, University of Nottingham

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

October 21, 2011

First Submitted That Met QC Criteria

October 24, 2011

First Posted (Estimate)

October 25, 2011

Study Record Updates

Last Update Posted (Estimate)

December 19, 2012

Last Update Submitted That Met QC Criteria

December 18, 2012

Last Verified

December 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L/7/2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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