None listed
Conditions
Brief summary
Banana pseudo stem tender core contains nutritional compounds that are crucial for health. This project aims to assess the feasibility and tolerability of a dietary supplement derived from banana pseudo stem tender core, which is high in fibre, polyphenols and minerals, and its effect on clinical measures, gut microbiome, and urine markers. To this end, a randomised controlled trial with 46 (23 in each arm) participants will be conducted. Participants will be randomly allocated to receive either the banana pseudo stem powder (intervention) or maltodextrin (placebo) over a period of 4-weeks. Participants, investigators, assessors, and study statistician will be blinded to group allocation.
Interventions
The intervention is a powder derived from Banana pseudo stems, and will be provided in 5g sachets. Participants are expected to consume 10g/day (2 sachets/day) mixed with usually consumed food items such as yogurt, pasta or soup. Instructions (participant information booklet) on how to administer the intervention will be provided to participant by a registered nutritionist.
Sachets required (56 sachets) for the duration of the trial (4 weeks) will be provided to the participants by the study in
The intervention is a powder derived from Banana pseudo stems, and will be provided in 5g sachets. Participants are expected to consume 10g/day (2 sachets/day) mixed with usually consumed food items such as yogurt, pasta or soup. Instructions (participant information booklet) on how to administer the intervention will be provided to participant by a registered nutritionist. Sachets required (56 sachets) for the duration of the trial (4 weeks) will be provided to the participants by the study investigator/research assistant at the beginning of the study and participants will need to pick up the investigational products from the study centre at Geelong during their first in-person study visit. Participant will need to complete a daily diary to record daily intakes and total up the sachets consumed at the end of the week and transpose these values to a weekly adherence online questionnaire, which will be sent to participants via email. Participants will need to return any un-consumed sachets and the daily diaries to the study investigators at the end of the study.
Sponsors
Deakin University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
• Community dwelling healthy adults aged between 18-65. • Able to understand study materials and instructions in English. • Live within the greater Geelong/Melbourne region. • No major diseases (e.g., diabetes, cancer, bipolar disorder), health concerns (e.g., awaiting test results or medical consultation), medical conditions that may affect participant adherence to the trial intervention as determined by investigators (e.g., cognitive disorders, intellectual disability) or history of previous GI surgery, except cholecystectomy or haemorrhoidectomy. • Willingness to commit to consuming the investigational products. • Must have access to the internet and a computer/smartphone/tablet. • Be willing to comply with all requirements and procedures of the study. • Agree not to enrol in another interventional clinical research trial during part of the study.
Exclusion criteria
• Pregnant or lactating women. • Perceived or formally diagnosed food intolerance (e.g., lactose intolerance, gluten intolerance) or allergies (e.g., dairy or protein allergies). • Following any therapeutic diets (e.g., calorie-restricted diet, low FODMAP). • Co-existing eating disorder. • Any major GI disorders such as inflammatory bowel disease (IBD), coeliac disease, or irritable bowel syndrome (IBS). • Current use of prebiotic, probiotic or fibre supplements or use of these supplements in the past month. • Antibiotic use within the past month.
Outcome results
None listed