Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001001482p
Ethics application status
Not yet submitted
Date submitted
25/08/2025
Date registered
10/09/2025
Date last updated
10/09/2025
Date data sharing statement initially provided
10/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Nutritional Density and Gut Transit Times in Functional Dyspepsia
Scientific title
Assessing Lipid Effects on Gastrointestinal Motility and Fermentation Patterns in Functional Dyspepsia Using the Atmo Gas-Sensing Capsule
Secondary ID [1] 315216 0
University of Melbourne CT ID: 33406
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional Dyspepsia 338664 0
Condition category
Condition code
Oral and Gastrointestinal 334955 334955 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Test meals with varying lipid doses as follows:
• Low-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 3 g saturated fat/serve and 240 mL water.
• Moderate-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 6 g saturated fat/serve and 240 mL water.
• High-fat: 35 g oat-based cereal bar (Atmo Motility Bar) with 200 g of a modified yogurt containing 16 g saturated fat/serve and 240 mL water.

Participants will be asked to consume the test meals within 15 minutes under the supervision of a member of the research team (e.g., dietician/nutrition scientist).

The Atmo Gas-Sensing capsule will be used to measure gastrointestinal transit time and fermentation profile in response to the test meals. As such, participants will then be asked to ingest the Atmo Gas-sensing capsule immediately after ingesting the test meal under the supervision of a member of the research team.

Each study visit will be separated by a 3-day washout period wherein a member of the research team will monitor capsule excretion 24-48 h after each study visit.
Intervention code [1] 331827 0
Lifestyle
Comparator / control treatment
Healthy adults without Functional Dyspepsia will be subjected to the same intervention wherein they will be required to ingest the same test meals and the Atmo Gas-Sensing capsule on three separate study visits in a randomised order. Each study visit will be separated by a 3-day washout period.
Control group
Active

Outcomes
Primary outcome [1] 342585 0
Gastrointestinal transit time
Timepoint [1] 342585 0
Postprandial during the three study visits
Secondary outcome [1] 451398 0
Gastrointestinal symptom severity
Timepoint [1] 451398 0
Before the ingestion of the test meal, 30 min, and 1 hour postprandial during the three study visits.
Secondary outcome [2] 451399 0
Regional fermentation gas profile as H2 and CO2 as a composite secondary outcome
Timepoint [2] 451399 0
Postprandial during the three study visits

Eligibility
Key inclusion criteria
• Adults aged 18-65 years of age
• Diagnosed with FD – PDS subtype (Rome IV criteria) by gastroenterologist or healthy controls
• BMI greater than or equal to 18.5 kg/m2 and less than 30.0 kg/m2
• Ability to adhere to diet and capsules procedures
• Ability to consent to study requirements
• Sufficient English to provide informed consent and complete study questionnaires
• Willing to abstain from restricted medications, supplements, and foods during the study periods (~1 month duration)
• For females of childbearing potential: agreement to use highly effective contraception during the study
• Symptomatic at the time of recruitment
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Evidence of organic GI disease (e.g. peptic ulcer, coeliac disease, inflammatory bowel disease, GI malignancy) by history, investigation or recent endoscopy
• Prior significant GI surgery (except appendectomy/cholecystectomy)
• Severe comorbidities
• Pregnancy/breastfeeding
• Food allergies relevant to test meals
• Inability to swallow capsule
• Known gastroesophageal strictures, obstruction or swallowing disorders
• Use of medications known to significantly affect gastrointestinal motility that cannot be safely withheld (e.g. prokinetics, laxatives, opioids, anticholinergics, antidiarrheals or proton pump inhibitors not withheld per protocol)
• Commencement or change in dose of antibiotics, pre-, pro-, synbiotics or fibre supplements and digestive enzymes within 1 month prior to study
• Recent participation in other studies involving intervention/measurements that may impact gastrointestinal motility (past 30 days)
• Non-compliance with study procedures (e.g. inability to consume control diet and/or attend all three study visits)
• Current smoker or history of smoking within the past 3 months prior to study
• Positive Helicobacter pylori status
• Significant loss of weight within the past 3 months prior to study
• Other DGBI (e.g. IBS-C/D) or with functional constipation
• Chronic intake of NSAIDS within the past 3 months prior to study
• Patients with implantable or portable electro-mechanical medical devices (e.g., pacemakers)
• Patients with GERD, diverticulitis, suspected obscure GI bleeding, gastric bezoar or radiation enteritis
• Requiring an MRI during the study duration or 3 months after the study

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation to intervention order will be concealed through central randomisation by computer. Intervention order will also be concealed from both participants and study personnel (double-blind) through coding of treatments. Meals will be prepared and coded by a separate team member not involved in data collection to ensure blinding. All outcome assessors will remain blinded to order of allocation by assigning each intervention arm a code that does not make reference to the intervention details. All participants will also be assigned a study ID which will be used throughout the analysis of data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be generated a computer program https://www.sealedenvelope.com and managed by an independent team member not involved in data collection or analysis. The schedule will be provided to the Clinical Trial Coordinator or delegate and stored on Research SharePoint owned by Jessica Biesiekierski (backed up to University of Melbourne). The Clinical Trial Coordinator or delegate will upload the randomisation schedule to the randomisation module in REDCap.
Randomisation will occur after participants have completed the baseline assessments. At the time of randomisation, the delegated study team member will press the “Randomise” button in the randomisation instrument in the participant's REDCap record. On pressing the button, the study team member will be alerted that a treatment arm has been allocated to a participant.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/11/2025
Actual
Date of last participant enrolment
Anticipated
1/11/2026
Actual
Date of last data collection
Anticipated
31/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 319783 0
Government body
Name [1] 319783 0
NHRMC
Country [1] 319783 0
Australia
Primary sponsor type
University
Name
University of Melbourne
Address
Country
Australia
Secondary sponsor category [1] 322390 0
None
Name [1] 322390 0
Address [1] 322390 0
Country [1] 322390 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 318342 0
Science, Technology, Engineering, Mathematics and Medicine (STEMM 1)- Greater Than Low Risk (GTLR) committee
Ethics committee address [1] 318342 0
Ethics committee country [1] 318342 0
Australia
Date submitted for ethics approval [1] 318342 0
15/09/2025
Approval date [1] 318342 0
Ethics approval number [1] 318342 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 143870 0
A/Prof Jessica Biesiekierski
Address 143870 0
Building 194 (Food & Nutrition) - Room 305, Medical Road, Parkville, The University of Melbourne, Victoria 3010
Country 143870 0
Australia
Phone 143870 0
+61 499272673
Fax 143870 0
Email 143870 0
[email protected]
Contact person for public queries
Name 143871 0
Jessica Biesiekierski
Address 143871 0
Building 194 (Food & Nutrition) - Room 305, Medical Road, Parkville, The University of Melbourne, Victoria 3010
Country 143871 0
Australia
Phone 143871 0
+61 499272673
Fax 143871 0
Email 143871 0
[email protected]
Contact person for scientific queries
Name 143872 0
Jessica Biesiekierski
Address 143872 0
Building 194 (Food & Nutrition) - Room 305, Medical Road, Parkville, The University of Melbourne, Victoria 3010
Country 143872 0
Australia
Phone 143872 0
+61 499272673
Fax 143872 0
Email 143872 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.