None listed
Conditions
Brief summary
IBS is a functional GI disorder that causes long-term GI symptoms that reduce quality of life. Dietary management of IBS using the low FODMAP approach can effectively manage symptoms, but may indirectly compromise other aspects of gut health, including bowel habit and the gut bacteria. We have identified two types of dietary fibre whose functional properties may address these potential consequences and optimise dietary management of this condition. The aim of this clinical is to provide the low FODMAP diet to participants with IBS, with or without these fibres, in order to investigate their effects on GI symptoms, GI function and the gut bacteria.
Interventions
The intervention will consist of two different dietary intervention periods lasting 14 days each. Participants will be provided with intervention diets during these periods consisting of three main meals (i.e. cereals, stir-fries, pastas) and 2-3 snack items (i.e. nuts, muffins) daily. The meals provided to participants are cooked in a commercial grade kitchen, pre-portioned, vacuum-sealed and frozen where appropriate.
Participants will be permitted to consume additional foods outside of their
The intervention will consist of two different dietary intervention periods lasting 14 days each. Participants will be provided with intervention diets during these periods consisting of three main meals (i.e. cereals, stir-fries, pastas) and 2-3 snack items (i.e. nuts, muffins) daily. The meals provided to participants are cooked in a commercial grade kitchen, pre-portioned, vacuum-sealed and frozen where appropriate. Participants will be permitted to consume additional foods outside of their intervention diets, and will be provided with a recommended snack list to help guide food choices. These recommended food choices will contain limited fibre content in order to maintain adherence to the dietary interventions. The average energy provided by the intervention diets is approximately 8000 kJ/d, with fibre content varying based on the type of dietary intervention: * Diet 1: Approximately 31 g/d. * Diet 2: Approximately 46 g/d (including 15 g/d resistant starch). Participants will be provided with food records to assess adherence to the dietary interventions. * A minimum 21-day washout period will separate each intervention arm (including control). Two other periods will take place prior to the first dietary (either intervention or control). During these periods, participants will consume their normal, habitual diets. No intervention products will be provided * Screening (5 days): Symptom assessment only, prior to inclusion (described under Eligibility) * Baseline (7 days): Assessment of outcome measures at baseline, following inclusion
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* IBS defined by ROME IV diganostic criteria. Potential participants not been formally diagnosed with IBS but presenting with the clinical features of the condition (i.e. recurrent abdominal pain and associated changes to bowel habit) will be referred to an appropriate medical doctor (either study gastroenterologist or their general practitioner) for formal diagnosis based on ROME IV criteria. * Currently symptomatic Eligible participants will then be invited to undertake screening to evaluate their IBS symptoms over five days. Symptoms will be assessed via a 100-mm VAS, where 0 mm indicates no symptoms and 100 mm represents the worst symptoms experienced. Participants whose scores are at least 30 mm for overall symptoms on the VAS will be included in the study.
Exclusion criteria
* Consumption of a special diet (i.e. low FODMAP, vegan diet). * Significant comorbidities (i.e. diabetes, chronic kidney disease). * Use of antibiotic therapies in the month preceding study commencement. * Consumption of prebiotics and probiotics in the month preceding study commencement. * Use of medication that potentially affects GI transit (i.e. hypomotility agents, laxatives). * Pregnancy or planning pregnancy. * Current smoker. * Unable to give written informed consent.
Outcome results
None listed