None listed
Conditions
Brief summary
This study aims to determine if a new chicken and plant protein nugget can improve an individual’s gut microbiome when it is eaten consistently (i.e., every day for two weeks). The nugget was created specifically for autistic people with feeding challenges or selective eating preferences. It has been modified in response to autistic people’s feedback about pleasant and unpleasant sensory components of foods in a prior study (e.g., the look, taste, or smell of certain foods). We are trying to create a sensory-friendly food for autistic people that can help improve their gut microbiome. The nugget we are developing uses a modified ratio of protein and fibre that we hope will improve gut microbiome. The nugget has been sensory-modified based on feedback from autistic individuals and caregivers with feeding challenges. The created nugget is not a medicine – it is a sensory-modified food product.
Interventions
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 pr
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.
Sponsors
La Trobe University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosed autistic adults Current or past lived experience of feeding challenges Can read and understand English.
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
Outcome results
None listed