Skip to content

Exploring the tolerability of nutritive and non-nutritive sweeteners in people with irritable bowel syndrome

Exploring the tolerability of nutritive and non-nutritive sweeteners in people with irritable bowel syndrome

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000185561
Enrollment
20
Registered
2024-02-27
Start date
2024-04-01
Completion date
2024-07-15
Last updated
2024-03-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

little is known about the gastrointestinal effects of these sweeteners, particularly in people with irritable bowel syndrome (IBS). This study will compare for the first time, the tolerability of 5 sweeteners - erythritol, monk fruit extract, stevia, allulose and sucrose in people with IBS whose symptoms are well controlled on a low FODMAP diet. The low FODMAP diet restricts intake of six sugars - fructose, lactose, oligosaccharides (fructans and galactooligosaccharides), and sugar polyols (sorbitol, mannitol). These six sugars are well known to trigger symptoms in people with IBS, and their collective reduction via a low FODMAP diet relieves symptoms in around 3/4 people with the condition.

Interventions

This study will compare for the first time, the tolerability of 5 sweeteners - erythritol, monk fruit extract, stevia, allulose and sucrose in people with IBS whose symptoms are well controlled on a low FODMAP diet. The study will following the following order - baseline (day 1), test period 1 (Days 2-3), washout (days 4-8), test period 2 (days 9-10), washout (days 11-15), test period 3 (days 16-17), washout (18-22), test period 4 (days 23-24), washout (days 25-29), test period 5 (days 30-31).

This study will compare for the first time, the tolerability of 5 sweeteners - erythritol, monk fruit extract, stevia, allulose and sucrose in people with IBS whose symptoms are well controlled on a low FODMAP diet. The study will following the following order - baseline (day 1), test period 1 (Days 2-3), washout (days 4-8), test period 2 (days 9-10), washout (days 11-15), test period 3 (days 16-17), washout (18-22), test period 4 (days 23-24), washout (days 25-29), test period 5 (days 30-31). In baseline, participants will consume their habitual, low FODMAP diet. They will also to complete a food diary, symptom questionnaire, and collect hourly breath samples from 8am to 8pm into breath collection bags. For the 2 days of each test period, participants will consume a supplied, low FODMAP diet provided by our certified, specialty pre-made meals supplier, WeFeedYou. During each test period, they will also consume 2 test foods e.g. breakfast (smoothie), morning tea (protein ball/bar/muffin). These tests foods will be masked with 1 of the 5 test sugars (erythritol, monk fruit extract, stevia, allulose or sucrose). Each test food will contain 1 sugar in the following amounts: 100% Sucrose - 30g 100%Erythritol - 49.4g 100%Monk fruit extract - 3.4g 100% Stevia - 0.7g 100% Allulose - 53.9g Participants will be randomised `and blinded to the order in which they are exposed to the 5 sweeteners during the test periods. Throughout each test period, participants will also complete the food diary (to monitor compliance) and daily symptom questionnaire (to monitor tolerance). On the 2nd day of each test period, participants will also collect hourly breath samples between 8am and 8pm into breath collection bags. These breath samples will be used to assess breath hydrogen response which is a marker of fermentation in the large intestine. In each 5 day washout period, participants will return to their habitual, low FODMAP diet.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

Irritable bowel syndrome and symptoms well controlled on a low FODMAP diet.

Exclusion criteria

- Age under 18 - need to be of adult consent age - Recent gastrointestinal surgery (within last 3 months) - this would have an effect on gut symptoms - Coeliac disease and/or other gastrointestinal disease, food allergy/intolerances, malnutrition, other dietary restrictions (e.g. vegan or vegetarian) - these conditions all require special diets and the supplied dietary intervention would potentially be contraindicated - Pregnancy or breastfeeding - this could potentially affects gut symptoms - Active psychological illness including eating disorders - this could affect compliance with the dietary intervention -People living outside of metro-Melbourne

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026