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Trial registered on ANZCTR


Registration number
ACTRN12624000361505
Ethics application status
Approved
Date submitted
5/03/2024
Date registered
28/03/2024
Date last updated
14/07/2024
Date data sharing statement initially provided
28/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A clinical trial of changes in gut microbiome from eating a newly created nugget for autistic feeding challenges
Scientific title
Microbiome Evaluation of a Newly Created Nugget for Autistic Feeding Challenges: A within-subjects clinical trial
Secondary ID [1] 311643 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
autism 333124 0
feeding challenges 333125 0
Condition category
Condition code
Diet and Nutrition 329821 329821 0 0
Other diet and nutrition disorders
Mental Health 329979 329979 0 0
Autistic spectrum disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Daily consumption of a newly developed nugget for 2 weeks.
All participants will consume 1 serving daily of 6 nuggets (approximately 20 g each) for two weeks. Participants have no additional dietary restrictions or requirements during the trial. Nuggets can be consumed with participants' choice of additional food and beverages.

CSIRO will develop a frozen “nugget” product using a new formulation of readily available commercial food ingredients. The ingredients will include texture variable protein from soy and chicken sources and commercially available breading. The nuggets will be specifically formulated with increased dietary soluble fibre to target microbiome composition when consumed regularly.

The nugget will be developed by CSIRO in coopers-plains. The final developed nugget will undergo microbiology testing to confirm it is safe for human consumption, prior to the commencement of this study. The nugget will be delivered frozen directly to the participant’s home. To ensure the product remains frozen, a temperature button will monitor the temperature of the storage container for the duration of transit for delivery. The serving size of the developed nugget will be between 4 to 6 nuggets depending on the final fibre composition and size of individual nuggets.

Before starting the 2-week trial, participants will complete a baseline survey of gastrointestinal symptoms and medication use along with a food frequency questionnaire.
During the 2-week trial: Participants will complete a daily survey to document the number of nuggets they consumed and any changes in their gastrointestinal symptoms.

A final survey of gastrointestinal symptoms and medications used during the trial will be completed after the intervention is finished.
Intervention code [1] 328131 0
Treatment: Other
Intervention code [2] 328233 0
Lifestyle
Comparator / control treatment
None. This is a pilot trial for proof of concept with the newly developed nuggets. A control group will not be used at this stage.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 337593 0
Gut microbiome diversity
Timepoint [1] 337593 0
baseline, day 7, and day 14 post-intervention commencement.
Primary outcome [2] 337594 0
Oral microbiome diversity
Timepoint [2] 337594 0
baseline, day 7, and day 14 post-intervention commencement.
Primary outcome [3] 337746 0
gut microbiome composition
Timepoint [3] 337746 0
baseline, day 7, and day 14 post-intervention commencement.
Secondary outcome [1] 432429 0
Oral microbiome composition
Timepoint [1] 432429 0
baseline, day 7, and day 14 post-intervention commencement.

Eligibility
Key inclusion criteria
Diagnosed autistic adults
Current or past lived experience of feeding challenges
Can read and understand English.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
History of severe allergic reactions to any ingredient in the nugget
Medical precautions for swallowing
Disrupted sensation of taste or smell
Pregnant or breastfeeding

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Total bacterial DNA will be extracted and their corresponding 16S rRNA gene library will be prepared from oral and faecal samples using the ZymoBIOMICS kits (Zymo). The taxonomic diversity of the gut and oral microbiota will be assessed from 16S rRNA gene using QIIME2 software. Analysis of microbial community composition will be conducted. Estimates of a-diversity will be calculated using Shannon Index, Simpson index and the Observed Species Index. Within group changes in a-diversity will be assessed by non-parametric Wilcoxon T test. Differences in a-diversity will be determined by Mann-Whitney U test. Bray-Curtis Dissimilarity Index will be used to quantify the compositional dissimilarity between groups followed by Permutational Multivariate Analysis of Variance (PERMANOVA) using Adonis function in Vegan using R to determine statistical differences.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
8/04/2024
Actual
1/05/2024
Date of last participant enrolment
Anticipated
3/06/2024
Actual
11/05/2024
Date of last data collection
Anticipated
28/06/2024
Actual
29/05/2024
Sample size
Target
20
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315970 0
University
Name [1] 315970 0
La Trobe University
Country [1] 315970 0
Australia
Funding source category [2] 315995 0
Government body
Name [2] 315995 0
CSIRO
Country [2] 315995 0
Australia
Primary sponsor type
University
Name
La Trobe University
Address
Country
Australia
Secondary sponsor category [1] 318112 0
Government body
Name [1] 318112 0
CSIRo
Address [1] 318112 0
Country [1] 318112 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314793 0
La Trobe University Human Ethics Committee
Ethics committee address [1] 314793 0
Ethics committee country [1] 314793 0
Australia
Date submitted for ethics approval [1] 314793 0
20/12/2023
Approval date [1] 314793 0
13/02/2024
Ethics approval number [1] 314793 0
HEC23487

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

Contacts
Principal investigator
Name 132750 0
Prof Alison Lane
Address 132750 0
OTARC, Level 2 Biological Sciences 2, Bundoora, Victoria 3086
Country 132750 0
Australia
Phone 132750 0
+61 3 9079 2463
Fax 132750 0
Email 132750 0
a.lane@latrobe.edu.au
Contact person for public queries
Name 132751 0
Brittany St. John
Address 132751 0
OTARC, Level 2 Biological Sciences 2, Bundoora, Victoria 3086
Country 132751 0
Australia
Phone 132751 0
+61 3 9479 2463
Fax 132751 0
Email 132751 0
b.stjohn@latrobe.edu.au
Contact person for scientific queries
Name 132752 0
Brittany St. John
Address 132752 0
OTARC, Level 2 Biological Sciences 2, Bundoora, Victoria 3086
Country 132752 0
Australia
Phone 132752 0
+61 3 9479 2463
Fax 132752 0
Email 132752 0
b.stjohn@latrobe.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
to protect participant privacy.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21805Informed consent form  b.stjohn@latrobe.edu.au



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.