NCT01459406

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for not_applicable healthy

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 25, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

December 19, 2012

Status Verified

December 1, 2012

Enrollment Period

1.2 years

First QC Date

October 21, 2011

Last Update Submit

December 18, 2012

Conditions

Healthy

Keywords

Gastrointestinal physiologyGastrointestinal response to sugarsMRIgastrointestinalstomachsmall bowelcolonglucosefructosefructanFODMAP

Outcome Measures

Primary Outcomes (1)

  • small bowel water content area under the curve

    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 Outcomes (6)

  • gastric emptying T50

    -45 min to 315 min

  • ascending colon volume

    -45 min to 315 min

  • ascending colon motility

    -45 min to 315 min

  • symptoms questionnaires

    -45 min to 315 min

  • bowel transit time

    24 hours

  • +1 more secondary outcomes

Study Arms (4)

Glucose drink

EXPERIMENTAL

Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g glucose

Dietary Supplement: Glucose

Fructose drink

EXPERIMENTAL

Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose

Dietary Supplement: Fructose

Fructan drink

EXPERIMENTAL

Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructan

Dietary Supplement: Fructan

Fructose and glucose drink

EXPERIMENTAL

Serial MRI of the gastrointestinal tract upon 500 ml water drink containing 40g fructose and 40 g glucose

Dietary Supplement: Fructose and glucose

Interventions

GlucoseDIETARY_SUPPLEMENT

500 ml water drink containing 40g glucose

Glucose drink
FructoseDIETARY_SUPPLEMENT

500 ml water drink containing 40g fructose

Fructose drink
FructanDIETARY_SUPPLEMENT

500 ml water drink containing 40g fructan

Fructan drink
Fructose and glucoseDIETARY_SUPPLEMENT

500 ml water drink containing 40g fructose and 40g glucose

Fructose and glucose drink

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NDDC BRU and Sir Peter Mansfield Magnetic Resonance Centre

Nottingham, Nottinghamshire, NG72UH, United Kingdom

Location

Related Publications (10)

  • Ong DK, Mitchell SB, Barrett JS, Shepherd SJ, Irving PM, Biesiekierski JR, Smith S, Gibson PR, Muir JG. Manipulation of dietary short chain carbohydrates alters the pattern of gas production and genesis of symptoms in irritable bowel syndrome. J Gastroenterol Hepatol. 2010 Aug;25(8):1366-73. doi: 10.1111/j.1440-1746.2010.06370.x.

    PMID: 20659225BACKGROUND

  • Marciani L, Cox EF, Hoad CL, Pritchard S, Totman JJ, Foley S, Mistry A, Evans S, Gowland PA, Spiller RC. Postprandial changes in small bowel water content in healthy subjects and patients with irritable bowel syndrome. Gastroenterology. 2010 Feb;138(2):469-77, 477.e1. doi: 10.1053/j.gastro.2009.10.055. Epub 2009 Nov 10.

    PMID: 19909743BACKGROUND

  • Hoad CL, Marciani L, Foley S, Totman JJ, Wright J, Bush D, Cox EF, Campbell E, Spiller RC, Gowland PA. Non-invasive quantification of small bowel water content by MRI: a validation study. Phys Med Biol. 2007 Dec 7;52(23):6909-22. doi: 10.1088/0031-9155/52/23/009. Epub 2007 Nov 8.

    PMID: 18029983BACKGROUND

  • Gibson PR, Barrett JS. The concept of small intestinal bacterial overgrowth in relation to functional gastrointestinal disorders. Nutrition. 2010 Nov-Dec;26(11-12):1038-43. doi: 10.1016/j.nut.2010.01.005. Epub 2010 Apr 24.

    PMID: 20418060BACKGROUND

  • Shepherd SJ, Parker FC, Muir JG, Gibson PR. Dietary triggers of abdominal symptoms in patients with irritable bowel syndrome: randomized placebo-controlled evidence. Clin Gastroenterol Hepatol. 2008 Jul;6(7):765-71. doi: 10.1016/j.cgh.2008.02.058. Epub 2008 May 5.

    PMID: 18456565BACKGROUND

  • Shepherd SJ, Gibson PR. Fructose malabsorption and symptoms of irritable bowel syndrome: guidelines for effective dietary management. J Am Diet Assoc. 2006 Oct;106(10):1631-9. doi: 10.1016/j.jada.2006.07.010.

    PMID: 17000196BACKGROUND

  • Barrett JS, Gearry RB, Muir JG, Irving PM, Rose R, Rosella O, Haines ML, Shepherd SJ, Gibson PR. Dietary poorly absorbed, short-chain carbohydrates increase delivery of water and fermentable substrates to the proximal colon. Aliment Pharmacol Ther. 2010 Apr;31(8):874-82. doi: 10.1111/j.1365-2036.2010.04237.x. Epub 2010 Jan 22.

    PMID: 20102355BACKGROUND

  • Khoshini R, Dai SC, Lezcano S, Pimentel M. A systematic review of diagnostic tests for small intestinal bacterial overgrowth. Dig Dis Sci. 2008 Jun;53(6):1443-54. doi: 10.1007/s10620-007-0065-1.

    PMID: 17990113BACKGROUND

  • Rumessen JJ, Gudmand-Hoyer E. Fructans of chicory: intestinal transport and fermentation of different chain lengths and relation to fructose and sorbitol malabsorption. Am J Clin Nutr. 1998 Aug;68(2):357-64. doi: 10.1093/ajcn/68.2.357.

    PMID: 9701194BACKGROUND

  • Bond JH Jr, Levitt MD, Prentiss R. Investigation of small bowel transit time in man utilizing pulmonary hydrogen (H2) measurements. J Lab Clin Med. 1975 Apr;85(4):546-55.

    PMID: 1120927BACKGROUND

MeSH Terms

Interventions

GlucoseFructoseFructans

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesKetosesPolysaccharides

Study Officials

  • Robin C Spiller, MD FRCP

    University of Nottingham

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2011

First Posted

October 25, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

December 19, 2012

Record last verified: 2012-12

Locations

GB(1)