Evidence of Adaptation to Dietary Exposure to FructansPERFECTNCT01963364
Pilot Study of the Effect of Fructans on Fermentation in the Colon & Transit
A study testing Inulin challenge and oligofructose supplement in people with Evidence of Adaptation to Dietary Exposure to Fructans, run by University of Nottingham at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Evidence of Adaptation to Dietary Exposure to Fructans
- What is being tested?
- Inulin challenge and oligofructose supplement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2013to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18-55
- Able to give informed consent
- Does not meet criteria for diagnosis of IBS on Rome III questionnaire
Who cannot join
- 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
Show all 25Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Sir Peter Mansfield Magnetic Resonance Centre
Nottingham, NG7 2RD
Nottingham Digestive Diseases Centre
Nottingham, NG7 2UH
About this study
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
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.
- Being tested
- Inulin challenge, oligofructose supplement
- Keywords
- fructans, inulin, oligofructose, colonic fermentation, microbiota, whoe gut transit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inulin challengeDietary supplement
Also called Orafti HP (Beneo-Orafti, Belgium)
On two study days one week apart, fasted participants will consume 500ml of water, flavoured with lime juice, containing 40g inulin.
oligofructose supplementDietary supplement
Also called Orafti P95 (Beneo-Orafti P95, Belgium)
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | All healthy volunteers Receives: Dietary Supplement: Inulin challenge; Dietary Supplement: oligofructose supplement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in whole gut transit time after one week (measured in hours) calculated using MRI marker capsule technique
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.
Measured: Difference (Delta) between baseline and after one week of intervention
Secondary outcomes (6)
Change in fasting colonic volume
Calculated from segmentation on MRI scans
Measured: Baseline and after one week of intervention
Change in colonic volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres
Calculated from segmentation on MRI scans
Measured: Baseline and after one week of intervention
Change in fasting colonic gas volume, measured in millilitres
Measured using MRI segmentation technique
Measured: Baseline and after one week of intervention
Change in colonic gas volume 8 hours after ingestion of 40 grams inulin dissolved in 500ml water flavoured with lime juice, measured in millilitres
Calculated from segmentation on MRI scans
Measured: Baseline and after one week of intervention
Change in breath hydrogen concentration, measured in parts per million before, 4 hours after, and 8 hours after ingestion of 40 grams inulin
Measured: Baseline and after one week of intervention
Change in faecal 5-HIAA concentration in μmol/g
measured by high performance liquid chromatography
Measured: baseline and after one week of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evidence of Adaptation to Dietary Exposure to FructansStudies of the same condition, open and under way.
- More trials run by University of NottinghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nottingham
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robin C Spiller, MD, Principal investigator, University of NottinghamGiles Major, MD, Principal investigator, University of NottinghamLuca Marciani, PhD, Principal investigator, University of Nottingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01963364
- Sponsor's protocol ID
- 11072013SCSMRI
- Acronym
- PERFECT
- Status last verified
- Jan 2014
- First submitted
- 8 Oct 2013
- Last updated
- 17 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01963364
- Acronym / sponsor ID
- PERFECT / 11072013SCSMRI
- Keywords
- fructans, inulin, oligofructose, colonic fermentation, microbiota, whoe gut transit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of NottinghamUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 16 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Inulin challenge, Dietary Supplement: oligofructose supplementAll healthy volunteers |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Aged 18-55
- Able to give informed consent
- Does not meet criteria for diagnosis of IBS on Rome III questionnaire
Key exclusion criteria (25 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inulin challengeAlso: Orafti HP (Beneo-Orafti, Belgium)On two study days one week apart, fasted participants will consume 500ml of water, flavoured with lime juice, containing 40g inulin. | Dietary supplement | Intervention group |
| oligofructose supplementAlso: Orafti P95 (Beneo-Orafti P95, Belgium)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. | Dietary supplement | Intervention group |
Primary outcome
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.
6 secondary outcomes
Change in fasting colonic volume
Time frame: Baseline and after one week of intervention
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
Change in fasting colonic gas volume, measured in millilitres
Time frame: Baseline and after one week of intervention
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
- The unit websiteLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin C Spiller, MD principal investigator
University of Nottingham
Giles Major, MD principal investigator
University of Nottingham
Luca Marciani, PhD principal investigator
University of Nottingham
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inulin challenge and oligofructose supplement in people with Evidence of Adaptation to Dietary Exposure to Fructans, run by University of Nottingham at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jan 2014.