Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000454673
Ethics application status
Approved
Date submitted
19/04/2023
Date registered
2/05/2023
Date last updated
23/02/2024
Date data sharing statement initially provided
2/05/2023
Date results information initially provided
23/02/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the feasibility and tolerability of a novel dietary supplement: The RePurpose Study
Scientific title
Investigating the feasibility and tolerability of a novel dietary supplement, developed from banana (Musa sp) pseudo stem in healthy adults: The RePurpose Study
Secondary ID [1] 308557 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal symptoms 328420 0
Depressive and anxiety symptoms 329761 0
Condition category
Condition code
Mental Health 325439 325439 0 0
Depression
Mental Health 325440 325440 0 0
Anxiety
Oral and Gastrointestinal 326660 326660 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
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.
Intervention code [1] 325007 0
Treatment: Other
Comparator / control treatment
Maltodextrin will be used as the placebo: this is a mixture of oligosaccharides derived from starch and available in a powder form. The placebo will also 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 on how to administer the intervention will be provided to participants 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 study 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.
Control group
Placebo

Outcomes
Primary outcome [1] 333295 0
Feasibility (composite primary outcome) will be evaluated by measuring the following:
- Intervention feasibility will be assessed by adherence to the study products, using a daily adherence diary and weekly online adherence questionnaire.
-Study feasibility will be evaluated by recruitment and attrition rate, using a study specific database.
Timepoint [1] 333295 0
Adherence to the study product will be measured post-baseline daily and at the end of week-1, 2, 3 and 4.
Recruitment and attrition rate will be evaluated at the end of the study (week-4).
Primary outcome [2] 333296 0
Tolerability (composite primary outcome) will be measured by changes in gastrointestinal (GI) symptoms (assessed by simple numeric rating scale) and stool consistency (assessed by Bristol Stool Form Scale questionnaire).
Timepoint [2] 333296 0
Tolerability will be measured at baseline (every other day for 3 days) and post-baseline at week-1, 2, 3 and 4 (study end) over three time points (every other day for 3 days).
Secondary outcome [1] 416534 0
Psychological symptoms assessed by the short-form version of Depression Anxiety Stress Scale-21 questionnaires.
Timepoint [1] 416534 0
Baseline and at the end of the study (week-4).
Secondary outcome [2] 416535 0
Quality of life assessed by the Assessment of Quality of Life (AQoL)-8D questionnaire.
Timepoint [2] 416535 0
Baseline and at the end of the study (week-4).
Secondary outcome [3] 416536 0
Perceived wellbeing assessed by the World Health Organisation Well-Being Index.
Timepoint [3] 416536 0
Baseline and at the end of the study (week-4).
Secondary outcome [4] 416537 0
Gut microbiota composition and diversity assessed by 16s rRNA gene sequencing.
Timepoint [4] 416537 0
Baseline and at the end of the study (week-4).
Secondary outcome [5] 416538 0
Urine metabolomics assessed by high-throughput Nuclear Magnetic Resonance
Timepoint [5] 416538 0
Baseline and at the end of the study (week-4).

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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.

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)
A random unique three-character alphanumeric study kit code (e.g., KL5, ZA1, CJ8) will be added in place of a group allocation. An unblinded research assistant (not involved in any other study procedures) will make up study kits according to the group and label each with the appropriate kit code. This will ensure that study investigators, statistician, and participants will be blinded to the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A third party, independent of the research team, will develop the computer-generated randomisation table utilising random block sizes and partitioned by stratum 1) age: 18-44, sex: female; 2) age 45-65, sex: female; 3) age: 18-44, sex male; 4) age 45-65, sex: male.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Baseline characteristics will be summarized using mean (standard deviation) or median (interquartile range) for continuous variables and frequency (%) for categorical variables. The analyses will observe intention-to-treat, i.e., participants will be analysed according to the group to which they were allocated. Additionally, objective outcomes (e.g., gut microbiota and urine markers) will also be analysed based on per protocol analysis. We will use logistic regression for the binary outcomes, and linear regressions for continuous outcomes. In each model, we will include study group (intervention vs. control), timepoint (follow-up vs. baseline) and a study group-by-timepoint interaction as covariates. The P-value of the study-group-by-timepoint interaction will be used to test the difference in change between study groups. As a sensitivity analyses, we will impute the missing information to ensure dropouts or missing information will not affect the general interpretation of the outcomes.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
5/05/2023
Actual
5/05/2023
Date of last participant enrolment
Anticipated
1/12/2023
Actual
13/11/2023
Date of last data collection
Anticipated
1/01/2024
Actual
20/12/2023
Sample size
Target
46
Accrual to date
Final
30
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 312805 0
University
Name [1] 312805 0
Deakin University
Country [1] 312805 0
Australia
Funding source category [2] 312806 0
University
Name [2] 312806 0
Seed funding, Deakin University
Country [2] 312806 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway
Burwood VIC 3125
Australia
Country
Australia
Secondary sponsor category [1] 314450 0
None
Name [1] 314450 0
Address [1] 314450 0
Country [1] 314450 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312090 0
Deakin University Human Research Ethics Review Committee
Ethics committee address [1] 312090 0
Melbourne Burwood Campus,
221 Burwood Highway, Burwood, VIC 3125
Ethics committee country [1] 312090 0
Australia
Date submitted for ethics approval [1] 312090 0
25/07/2022
Approval date [1] 312090 0
07/11/2022
Ethics approval number [1] 312090 0
2022-218

Summary
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.



Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123438 0
Dr Hajara Aslam
Address 123438 0
Food and Mood Centre, IMPACT –
Institute for Mental and Physical Health
and Clinical Translation (IMPACT), Deakin
University (Barwon Health)
School of Medicine
PO Box 281
Geelong Victoria 3220
Country 123438 0
Australia
Phone 123438 0
+61 0431068363
Fax 123438 0
Email 123438 0
f.hajara@deakin.edu.au
Contact person for public queries
Name 123439 0
Dr Hajara Aslam
Address 123439 0
Food and Mood Centre, IMPACT –
Institute for Mental and Physical Health
and Clinical Translation (IMPACT), Deakin
University (Barwon Health)
School of Medicine
PO Box 281
Geelong Victoria 3220
Country 123439 0
Australia
Phone 123439 0
+61 0431068363
Fax 123439 0
Email 123439 0
f.hajara@deakin.edu.au
Contact person for scientific queries
Name 123440 0
Dr Hajara Aslam
Address 123440 0
Food and Mood Centre, IMPACT –
Institute for Mental and Physical Health
and Clinical Translation (IMPACT), Deakin
University (Barwon Health)
School of Medicine
PO Box 281
Geelong Victoria 3220
Country 123440 0
Australia
Phone 123440 0
+61 0431068363
Fax 123440 0
Email 123440 0
f.hajara@deakin.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


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.