Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000681550
Ethics application status
Approved
Date submitted
14/05/2024
Date registered
28/05/2024
Date last updated
28/05/2024
Date data sharing statement initially provided
28/05/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of a food-derived polyphenols supplement on plasma uric acid and other metabolic markers in healthy subjects
Scientific title
Effect of a food-derived isoquercitrin supplement on plasma uric acid and other metabolic markers: A randomised, double-blinded, placebo-controlled, cross-over trial in healthy adults
Secondary ID [1] 312150 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
potential hyperuricemia 333796 0
Condition category
Condition code
Diet and Nutrition 330467 330467 0 0
Other diet and nutrition disorders
Metabolic and Endocrine 330541 330541 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-Name: polyphenol treatment and placebo
- the dose administered: 100 mg daily
- the duration of administration: 6 weeks and crossover
-the duration of the washout period: 6 weeks
-overall duration of the study: 18 weeks in total, comprising 6 weeks of treatment/placebo, 6 weeks washout and another 6 weeks of treatment/placebo
- the mode of administration: oral tablet
-adherence: Compliance will be monitored by participants recording their consuming time, date of missing dose (if any) by REDCap survey. Subjects will also be asked to return the unconsumed tablets and empty capsule containers/blister packs at each follow-up visit for capsule counting. Also, the compliance will be monitored by determining quercetin plasma concentrations.
Intervention code [1] 328584 0
Prevention
Comparator / control treatment
Controlled trials:
-placebo: potato starch
Control group
Placebo

Outcomes
Primary outcome [1] 338237 0
Change in plasma uric acid
Timepoint [1] 338237 0
Baseline, 6-week following end of first randomised treatment, and 6-week following end of second randomised treatment
Secondary outcome [1] 435098 0
Change in plasma glucose
Timepoint [1] 435098 0
Baseline, 6-week following end of first randomised treatment, and 6-week following end of second randomised treatment
Secondary outcome [2] 435372 0
Change in plasma insulin
Timepoint [2] 435372 0
Baseline, 6-week following end of first randomised treatment, and 6-week following end of second randomised treatment

Eligibility
Key inclusion criteria
18 years or more
• BMI above 25 kg/m2
• Not a present smoker (cigarette or vape)
• Not a regular heavy alcohol drinker (over 1000 mL beers/300 mL wine/90 mL spirits regularly/day)
• Not regularly consuming dietary plant-based supplements
• Not regularly consuming anti-inflammatory drugs (such as ibuprofen)
• Not pregnant, planning on becoming pregnant, breastfeeding
• Not diagnosed with heart diseases (cardiovascular, hypertension, etc) or diabetes mellitus, gout and/or kidney disease)
• Not have implanted cardiac defibrillator
• Not following a medically prescribed diet
• Able to adhere to the study protocol and consume capsules provided
• Available to attend four testing sessions at the Notting Hill BASE Facility
• Have not experienced fainting during blood collection previously
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
allocation involved contacting the holder of the allocation schedule who was "off-site" or at central administration sit
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
8/05/2024
Date of last participant enrolment
Anticipated
31/07/2024
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
30
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 316511 0
Government body
Name [1] 316511 0
National Ministry of Education - China Scholarship Council
Country [1] 316511 0
China
Funding source category [2] 316513 0
University
Name [2] 316513 0
Monash University
Country [2] 316513 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 318751 0
None
Name [1] 318751 0
Address [1] 318751 0
Country [1] 318751 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315309 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 315309 0
https://www.monash.edu/researchoffice/ethics
Ethics committee country [1] 315309 0
Australia
Date submitted for ethics approval [1] 315309 0
09/04/2024
Approval date [1] 315309 0
11/04/2024
Ethics approval number [1] 315309 0

Summary
Brief summary
This study aims to examine the impact of a naturally occurring polyphenol extracted from tea on blood uric acid levels in healthy adults. Researchers will administer the polyphenol to participants and monitor changes in their uric acid concentrations for 6 weeks treatment. The goal is to determine if this tea-derived compound can effectively lower uric acid levels. The study will provide valuable insights into the potential health benefits of tea polyphenols.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134290 0
Prof Gary Williamson
Address 134290 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 134290 0
Australia
Phone 134290 0
+61 03 9902 4270
Fax 134290 0
Email 134290 0
gary.williamson1@monash.edu
Contact person for public queries
Name 134291 0
Lu Liu
Address 134291 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 134291 0
Australia
Phone 134291 0
+61 451576278
Fax 134291 0
Email 134291 0
lu.liu2@monash.edu
Contact person for scientific queries
Name 134292 0
Lu Liu
Address 134292 0
Monash University, Wellington Rd, Clayton VIC 3800
Country 134292 0
Australia
Phone 134292 0
+61 451576278
Fax 134292 0
Email 134292 0
lu.liu2@monash.edu

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.