Effect of Rate Of Delivery on Colonic Fermentation of inuliN (EON)

Sponsor

University of Nottingham (Other)

Overall Status

Recruiting

CT.gov ID

NCT05619341

Collaborator

(none)

Enrollment

Location

Arms

5.1

Anticipated Duration (Months)

3.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To test whether slowing the rate of delivery of inulin with either psyllium or divided dosing of inulin, will reduce colonic gas production as compared to inulin combined with placebo.

To obtain pilot data on link between habitual diet and fermentation of inulin.

Condition or Disease	Intervention/Treatment	Phase
Irritable Bowel	Dietary Supplement: psyllium Dietary Supplement: inulin	N/A

Detailed Description

Our challenge is to understand how fibre interacts with whole-gut function to alter colonic fermentation of fermentable oligo-di-mono-saccharides and polyhydric alcohols (FODMAPs). We have previously performed the study entitled the Effect of modified Cellulose On COlonic fermentAtion of inulin (COCOA) in which a modified methylcellulose (food grade product -modified celluloses- which can form gels at body temperature ) was used and showed some reduction, but this was not statistically significant, and much less than with psyllium. We wish to determine whether slowing delivery of inulin will produce a lowering of breath hydrogen equivalent to that seen with psyllium. We also found that the breath hydrogen curve had not shown a consistent fall by 6 hours suggesting that 6 hours was not long enough to accurately define the area under the curve (AUC). We now plan to use breath sampling bags to collect breath samples at home to define the breath hydrogen response over whole 24-hour period post ingestion of test drink. We also hypothesise that the colonic microbiota will influence the fermentation of inulin and will collect stool samples to allow future work to correlate microbiota with fermentation rates as part of a separate Medical Research Council funded study.

Aim Our aim is to test the hypothesis that slowing delivery of inulin will achieve a similar reduction in breath hydrogen production over the 24 hours following ingestion as seen when co-administered with psyllium.

Objective The primary objective is to compare the effect of bolus administration of inulin (co-administrated with psyllium or maltodextrin placebo) with divided dose delivery of inulin over 6 hours on total gas production over 24 hours.

Secondary Objectives Secondary objectives will be 1) to compare breath hydrogen AUC 0-24h with values based on AUC 0-6h that was assessed in the previous study (COCOA) to see how much the shorter period underestimates H2 production; 2) to assess breath methane production AUC 0-24h after consumption of test drinks; and 3) to collect pilot data on habitual dietary FODMAPs intake to assess whether this alters fermentation of inulin.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

3 way cross-over3 way cross-over

Masking:

Single (Participant)

Masking Description:

psyllium / maltodextrin added to 500ml water + inulin 20g

Primary Purpose:

Basic Science

Official Title:

Effect of Rate Of Delivery on Colonic Fermentation of inuliN (EON)

Actual Study Start Date :

Oct 28, 2022

Anticipated Primary Completion Date :

Apr 1, 2023

Anticipated Study Completion Date :

Apr 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: inulin 20g inulin in 500ml water	Dietary Supplement: inulin long chain fructan
Active Comparator: inulin + psyllium Inulin 20g + 20g psyllium in 500 ml water	Dietary Supplement: psyllium psyllium 20g Dietary Supplement: inulin long chain fructan
Active Comparator: inulin divided doses 2.5 g inulin in 62.5ml water given at 45 minute intervals	Dietary Supplement: inulin long chain fructan

Arm

Intervention/Treatment

Placebo Comparator: inulin

20g inulin in 500ml water

Dietary Supplement: inulin

long chain fructan

Active Comparator: inulin + psyllium

Inulin 20g + 20g psyllium in 500 ml water

Dietary Supplement: psyllium

psyllium 20g

Dietary Supplement: inulin

long chain fructan

Active Comparator: inulin divided doses

2.5 g inulin in 62.5ml water given at 45 minute intervals

Dietary Supplement: inulin

long chain fructan

Outcome Measures

Primary Outcome Measures

Hydrogen production [2 days]
AUC 0-24h

Secondary Outcome Measures

Methane production [2 days]
AUC 0-24h
Intake of FOOMDAPS [4 days]
24 h food diary X 4

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Aged 18 or older.
Able to give informed consent.
Scoring ≤3 (i.e., mild, or less) for symptoms of flatulence, bloating and abdominal pain 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 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 potentially compromising participation in the study e.g., type 1 diabetes mellitus, respiratory disease limiting ability to use breath hydrogen analyser, known intolerance to one of the test substances.
Will not agree to dietary restrictions required nor consume the standard meals required during the study day.
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 they might alter 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.