Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000055505
Ethics application status
Approved
Date submitted
14/12/2023
Date registered
23/01/2024
Date last updated
8/09/2024
Date data sharing statement initially provided
23/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of polyphenol rich sugarcane extract on the gut microbiome, mood and blood work.
Scientific title
Investigating the effect of polyphenol rich sugarcane extract on the gut microbiome, mood and blood work in healthy adults.
Secondary ID [1] 310774 0
None
Universal Trial Number (UTN)
Trial acronym
PRIME
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal health 331734 0
Blood biomarkers 331735 0
General wellbeing 331736 0
Mood 332537 0
Inflammation 332538 0
Condition category
Condition code
Oral and Gastrointestinal 328482 328482 0 0
Normal oral and gastrointestinal development and function
Blood 328483 328483 0 0
Other blood disorders
Mental Health 328484 328484 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The nutritional intervention is a Polyphenol Rich Sugarcane Extract PRSE. Participants are expected to consume two capsules a day, one in the evening and one at night at approximately the same time each day (± 60 mins). PRSE’s can be consumed with or without food and on an empty stomach. Each capsule contains 250 mg of PRSE.

Participants will receive either the control sample (placebo) or the PRSE sample for a duration of 3 months, followed by the reversal of conditions for the subsequent 3 months. The samples will be sent to participants via mail at the commencement of each phase. The nutritional intervention is to be completed (consumed) in the participants own setting (i.e. home/work).

There is no washout period between phases.

Daily adherence will be tracked through a short emailed online questionnaire, where participants record their daily intake. Additionally, at the end of each month, participants will report the number of capsules remaining.
Intervention code [1] 327632 0
Treatment: Other
Comparator / control treatment
Maltodextrin will be used as the placebo, which will be colour matched to the PRSE and loaded in the identical gel casing as the PRSE product.
Participants will receive either the control sample (placebo) or the PRSE sample for a duration of 3 months, followed by the reversal of conditions for the subsequent 3 months. The samples will be sent to participants via mail at the commencement of each phase. The nutritional intervention is to be completed (consumed) in the participants own setting (i.e. home/work).

Daily adherence will be tracked through a short online questionnaire emailed to participants, where they will record their daily intake. Additionally, at the end of each month, participants will report the number of capsules remaining.
Control group
Placebo

Outcomes
Primary outcome [1] 336876 0
Gut bacteria diversity and composition
Timepoint [1] 336876 0
Baseline, 3 months (end of phase 1, primary timepoint), 6 months (end of phase 2, primary timepoint)
Primary outcome [2] 336877 0
Blood markers (finger prick blood assessment): HBA1c, C-reactive protein, TAGs, Omega-3 status. Blood markers will be assessed as a composite primary outcome.
Timepoint [2] 336877 0
Baseline, 3 months (end of phase 1, primary timepoint), 6 months (end of phase 2, primary timepoint)
Primary outcome [3] 336878 0
Quality of life assessed by the Assessment of Quality of Life (AQoL)-8D questionnaire.
Timepoint [3] 336878 0
Baseline, 3 months (end of phase 1, primary timepoint), 6 months (end of phase 2, primary timepoint)
Secondary outcome [1] 430012 0
Change in Profile of Mood States-Adolescents (POMS-A)
Timepoint [1] 430012 0
Baseline, 3 months (end of phase 1), 6 months (end of phase 2)

Eligibility
Key inclusion criteria
- Aged 18-55 years of age
- Currently live in Australia
- Able to communicate fluently in English
- No history of / do not currently suffer from heart disease, high blood pressure, diabetes (Type 1 or Type 2) or any other chronic disease (in the judgement of the investigator) or medical conditions that may affect participant adherence to the trial investigation.
- Are not taking any medication (including antibiotics or frequent use of NSAIDs), herbal extracts, vitamin supplements, illicit substances, and are committed to abstaining from taking any non-critical medications from 2 weeks prior of commencement and throughout the study.
- Committed to maintaining current diet and exercise regime from one week prior to study commencement and for the duration of the study.
- Are not currently participating in any other trials involving investigational or marketed products within 30 days prior to study commencement.
-. Are able to provide self-assessed anthropometric measurements (i.e. height and weight and has access to scales).
- Willingness to comply with all requirements and procedures of the study.
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Pregnant, lactating or intending to become pregnant
- A smoker and / or alcoholic drinker (averages 2 or more standard drinks a day).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants will undergo random assignment to one of two groups, with group allocation concealed. A random, unique three-character alphanumeric code will be assigned by the manufacturer to each of the group allocations. This approach ensures that study investigators, statisticians, and participants remain blinded to the group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Participants will be assigned through simple randomisation using a computer-generated randomisation table created before the recruitment of participants. Allocation will follow the order of recruitment dates, placing participants into one of two groups.
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
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/06/2024
Actual
24/06/2024
Date of last participant enrolment
Anticipated
27/05/2024
Actual
19/08/2024
Date of last data collection
Anticipated
15/02/2025
Actual
Sample size
Target
100
Accrual to date
Final
98
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315005 0
Commercial sector/Industry
Name [1] 315005 0
Human Health and Wellbeing (PTE LTD) (HHW)
Country [1] 315005 0
Singapore
Funding source category [2] 315443 0
Commercial sector/Industry
Name [2] 315443 0
The Product Makers
Country [2] 315443 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
221 Burwood Highway Burwood, VIC 3125
Country
Australia
Secondary sponsor category [1] 317026 0
None
Name [1] 317026 0
Address [1] 317026 0
Country [1] 317026 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313976 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 313976 0
Ethics committee country [1] 313976 0
Australia
Date submitted for ethics approval [1] 313976 0
29/09/2023
Approval date [1] 313976 0
31/01/2024
Ethics approval number [1] 313976 0

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

Contacts
Principal investigator
Name 129990 0
Dr Daniel Dias
Address 129990 0
Deakin University, 221 Burwood Highway Burwood VIC 3125
Country 129990 0
Australia
Phone 129990 0
+61 3 924 46942
Fax 129990 0
Email 129990 0
[email protected]
Contact person for public queries
Name 129991 0
Daniel Dias
Address 129991 0
Deakin University, 221 Burwood Highway Burwood VIC 3125
Country 129991 0
Australia
Phone 129991 0
+61 3 924 46942
Fax 129991 0
Email 129991 0
[email protected]
Contact person for scientific queries
Name 129992 0
Daniel Dias
Address 129992 0
Deakin University, 221 Burwood Highway Burwood VIC 3125
Country 129992 0
Australia
Phone 129992 0
+61 3 924 46942
Fax 129992 0
Email 129992 0
[email protected]

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.