High carbohydrate diets with varied FODMAP content on the development of exercise-associated gastrointestinal symptoms during endurance exercise in endurance-trained athletes

Not Applicable

Completed

• Conditions: Gut disturbance during exercise; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Diet and Nutrition - Other diet and nutrition disorders

• Registration Number: ACTRN12624000060549
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-12-17
• Study Start: 2024-01-25
• Last Update Posted: 29 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

Key inclusion criteria:
The Inclusion criteria for the study is healthy male and female recreationally competitive endurance runners 18 – 50 years of age, with pre-existing exercise-associated gastrointestinal symptoms.
Only non-pregnant, non-breastfeeding women will participate during day 5 – 10 of the follicular phase of the menstrual cycle confirmed with testing serum estradiol, urinal and calendar-based counting of menstrual diary records (or through a menstrual app) (Gaskell et al, 2020, Snipe et al, 2018). This is to ensure hormonal levels are consistent at each experimental trial, and to reduce any risks that may cause harm to an unborn baby or fluctuations in hormonal levels experienced during breastfeeding.

Exclusion Criteria

Individuals presenting clinical diagnosis of gastrointestinal disease or disorders or individuals presenting any other forms of illness or disease due to confounding effects on gastrointestinal markers/outcomes. Individuals presenting soft tissue injury 1 month prior to participation due to the risk of re-occurrence of injury.
Exclusion criteria will be participants who have been following a dietary programme focussed on any changes to the GI function (e.g., a low FODMAP diet, low residue, or fibre-modified diets), or carbohydrate-manipulated diets (i.e., low carbohydrate high fat or ketogenic diets, within the last six months) or have been consuming any potential modifiers or enhancers of the GI integrity (e.g., probiotics, pre-biotics, symbiotic, or antibiotics) in the three months prior to testing. Participants who have a diagnosed food allergy will also be excluded due to potential allergens present in experimental foods or potential cross-contamination with the food manufacturing process of the experimental foods.
Participants will also be excluded if they have any GI infections, diseases, or disorders of the GI tract (e.g., IBS, inflammatory bowel disease, coeliac disease, diverticular disease, gastro-oesophageal reflux, or any other self-reported GI issues). If participants have consumed any non-steroidal antiinflammatory or stool-altering medications (e.g., laxatives, anti-diarrhoeal or stool softeners) within one month of the experimental protocols they will be excluded. Participants will also refrain from consuming any of the above whilst on the trial.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference in plasma intestinal fatty acid binding protein[Plasma analysis through ELISA testing Before exercise (baseline pimary start point), After exercise, 1 hr post-exercise (primary endpoint) and 2 hr post-exercise.]

Secondary Outcome Measures

Name	Time	Method
Differences in the perceived severity of exercise-associated gastrointestinal symptoms developed during endurance exercise.[A validated modified visual analog scale is used to determine the severity of gut symptoms from 0 (no symptoms) to 10 (severe symptoms warranting exercise cessation). Baseline (before exercise): every 15 minutes during exercise, post-exercise (in the recovery period), and every 15 minutes for 120 minutes during recovery. ]