ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12624000185561

Ethics application status

Approved

Date submitted

21/12/2023

Date registered

27/02/2024

Date last updated

27/02/2024

Date data sharing statement initially provided

27/02/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

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

Scientific title

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

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Irritable bowel syndrome

Condition category

Condition code

Oral and Gastrointestinal

Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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.

Intervention code [1]

Lifestyle

Comparator / control treatment

Sucrose

Control group

Active

Outcomes

Primary outcome [1]

Gastrointestinal symptoms (composite of abdominal pain, bloating/distension, satisfaction with bowel function, interference of bowel symptoms on daily life). This will be assessed using the IBS-Symptom severity score (IBS-SSS).

The IBS-SSS is a self-report questionnaire designed to assess the severity of symptoms in individuals with irritable bowel syndrome (IBS). The IBS-SSS consists of five items that assess the severity of abdominal pain, the frequency of abdominal pain, the severity of abdominal distension, dissatisfaction with bowel habits, and interference with quality of life.

The primary outcome will be the total score (0 to 500 points).

Timepoint [1]