Effect of Chronic Feeding of Inulin And Methylcellulose on Colonic Fermentation (CINNAMON)

November 13, 2024 updated by: University of Nottingham

A Randomised Placebo Controlled Trial of Chronic Feeding of INuliN And Methylcellulose On Colonic fermentatioN

To determine the effect on tolerance and gas production from chronic feeding of fermentable fibre (inulin) incorporated into a gel forming fibre (methylcellulose) compared with placebo (maltodextrin)

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Our challenge is to understand how various dietary fibres interact to alter colonic fermentation of FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) with the aim of reducing gaseous distension of the colon and hence symptoms. Our previous studies have shown how psyllium, a gel forming natural fibre can reduce gas production induced by a dietary FODMAP inulin when it reaches the colon. The investigators are exploiting a range of food grade modified celluloses which can form gels at body temperature to perform human studies to explore whether the beneficial effect of psyllium is unique or will be found with all gelling substances 2.

The investigators have completed a study using a modified methylcellulose which was shown to be non-inferior to psyllium.

Our previous studies point to the importance of habitual FODMAP intake which is likely to alter the microbiota, selecting those that can efficiently utilise fructans. The investigators want to understand whether chronic feeding of inulin along with methylcellulose, a gel-forming dietary fibre which persists in the colon, will significantly alter the tolerance to inulin relative to chronic feeding of inulin with a suitable placebo maltodextrin. Maltodextrin is rapidly absorbed in the small bowel and therefore has no effect on colonic fermentation. The investigators plan to run a chronic feeding study in IBS patients and wish to ascertain tolerability of repeated use as previous studies have only provided single doses.

With this in mind, the investigators plan to provide inulin and methylcellulose for daily consumption by healthy adults for a period of two weeks. The intervention will be divided into 3 portions to be taken before breakfast, lunch and supper. In week 1, the portions will contain 2.5 g of both inulin and methylcellulose in 62.5 mL water. In week 2, the portions will contain 5.0 g of both inulin and methylcellulose in 125 mL water. The participants will also follow the same chronic feeding schedule but with a maltodextrin placebo as opposed to methylcellulose, with randomisation of study schedule taking place at screening.

The investigators will use MRI at baseline and at 2 weeks to assess changes in colonic volume and transit utilising high MRI contrast capsules54. The investigators will collect stool samples at baseline and after 1 and 2 weeks of chronic feeding for each study intervention to monitor the expected changes in microbiota. The primary objective is to assess the fermentation of inulin given as a single 15g with or without methylcellulose from the breath hydrogen response at baseline and after the 2 weeks feeding. .

Study Type

Interventional

Enrollment (Estimated)

35

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 Contact

Study Contact Backup

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • • Aged between 18 and 65 years old.

    • Able to give informed consent.
    • Scoring ≤5 (i.e., mild, or less) for symptoms of flatulence, bloating, abdominal pain, loose stool, and hard stool in previous 2 weeks using a modified Gastrointestinal Symptom Rating Scale (5).
    • Agrees to consume the meals provided.
    • Agrees to not smoke during the breath hydrogen sampling period.

Exclusion Criteria:

  • • Pregnancy, lactating, or planning pregnancy during the course of the investigation declared by candidate.

    • History declared by the candidate of pre-existing gastrointestinal disorder that may affect bowel function.
    • 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 use breath hydrogen analyser, known intolerance to one of the test substances.
    • Has a body mass index (BMI) value less than 18.5 or greater than 35.
    • Will not agree to follow dietary and lifestyle restrictions required.
    • Unable to stop drugs known to alter GI motility including mebeverine, opiates, monoamine oxidase inhibitors, phenothiazines, benzodiazepines, calcium channel antagonists for the duration of the study (Selective serotonin reuptake inhibitors, low dose tricyclic antidepressants, antihistamines, and oral contraceptive pill will be recorded in the CRF but will not be an exclusion criteria).
    • Participants who are taking antibiotics or probiotics as it might alters gut microbiota.
    • 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.
    • 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.
    • Having taken part in a research study in the last 3 months involving invasive procedures or an inconvenience allowance.

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: methylcellulose
2.5 g of Inulin and 2.5g methylcellulose in 62.5 mL water given thrice daily for 7 days increasing to 5 g of Inulin and 5g methylcellulose in 125 mL water on day 8 continuing until day 14
Dietary supplement: methylcellulose
2.5 and 5 gm Methylcelllose heated to create a gel
Other Names:
  • Benecel
Dietary supplement: inulin
2.5 and 5 gm inulin powder dissolved in water
Placebo Comparator: Placebo
2.5 g of Inulin and 2.5g maltodextrin in 62.5 mL water given thrice daily for 7 days increasing to 5 g of Inulin and 5g maltodextrin in 125 mL water on day 8 continuing until day 14
Dietary supplement: inulin
2.5 and 5 gm inulin powder dissolved in water
Dietary supplement: maltodextrin
2.5 and 5gm maltodextrin dissolved in water
Other Names:
  • Glusidex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breath hydrogen 0-6 hours post ingestion
Time Frame: 0-6 hours
Area under curve (AUC) from time 0-6 hours (AUC 0-6) of breath hydrogen (ppm.hour) after consumption of inulin intake.
0-6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptoms
Time Frame: 14 days
1) Self-reported symptom scores relating to gastrointestinal tolerance during 2-week chronic feeding period
14 days
Breath hydrogen
Time Frame: 0-24 hours
2) Area under curve (AUC) of breath hydrogen and methane for period 0 - 24hr.
0-24 hours
Orocaecal transit
Time Frame: 0- 6 hours
Time for breath hydrogen to rise > 10ppm over baseline
0- 6 hours
Whole gut transit time
Time Frame: 0-7 days
assessed by marker transit
0-7 days
Fecal microbiota
Time Frame: 1 and 2 weeks post dosing
16s DNA analysis
1 and 2 weeks post dosing

Collaborators and Investigators

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

Sponsor

University of Nottingham

Collaborators

University of East Anglia

Investigators

  • Principal Investigator: Robin C Spiller, MD, 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 (Actual)

September 30, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

June 30, 2025

Study Registration Dates

First Submitted

August 9, 2024

First Submitted That Met QC Criteria

August 9, 2024

First Posted (Actual)

August 13, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FMHS-199-0524

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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