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Trial registered on ANZCTR
Registration number
ACTRN12624000242527
Ethics application status
Approved
Date submitted
1/02/2024
Date registered
12/03/2024
Date last updated
12/03/2024
Date data sharing statement initially provided
12/03/2024
Date results information initially provided
12/03/2024
Type of registration
Retrospectively registered
Titles & IDs
Public title
Effect of Phytolin, a dietary supplement, on postprandial glycaemic response to a bread sandwich: A randomised, cross-over trial in healthy subjects
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Scientific title
Effect of Phytolin, a dietary supplement, on postprandial glycaemic response to a high carbohydrate challenge: A randomised, cross-over trial in healthy subjects
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Secondary ID [1]
311434
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Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diabetes
332720
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Condition category
Condition code
Metabolic and Endocrine
329438
329438
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0
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Diabetes
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The two doses were created by dissolving the PRSE in water. The lower dose (0.5% w/w) will be 1g of PRSE dissolved in 199g of water and higher dose (5% w/w) will be 10g of PRSE dissolved in 190g of water. Along with the test drink a bread sandwich will be offered. The bread sandwich is formulated to deliver approximately 50g of carbohydrates. It consists of bread (103.4g), butter (5g) and ricotta cheese (15g). The participants are constants subjected to direct supervision to ensure the consumption of complete meal with the treatment drink.
Four treatment sessions will be scheduled for eligible participants at the BASE Facility. Each treatment session will be conducted 7 days apart. Pre-visit instructions will include a 10-hour fasting period before each session and adherence to a given low FODMAP diet on the previous day. Participants will also be instructed to avoid strenuous exercise for 24 hours before each visit.
During each treatment session, participants will undergo measurements of height, weight, waist circumference, body composition, and blood pressure. Fasting finger prick blood samples for glucose and insulin will be collected immediately before the meal intervention. In addition, a breath sample will also be collected to measure breath hydrogen to check whether the participant adhered to the low FODMAP diet. Timers will be started upon the first bite of the meal. Participants will be advised to alternate between the test drink and the bread sandwich. In addition, they will also be required to finish the meal within 10-15 minutes. Additional finger prick blood samples and breath samples will be taken at 15-minute time intervals during the 1st hour following the meal intervention and every 30 minutes during the next two hours. Post blood samples for insulin will only be taken every 30 minutes.
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Intervention code [1]
327877
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Prevention
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Comparator / control treatment
A placebo drink with equivalent amounts of sugars (sucrose, glucose, and fructose) to each dose will be used.
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Change in postprandial blood glucose
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Assessment method [1]
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Glucometer
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Timepoint [1]
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Pre treatment (-10 minutes), Post treatment (+15 minutes, +30 minutes, +45 minutes, +60 minutes, +90 minutes, + 120 minutes, +150 minutes, +180 minutes)
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Secondary outcome [1]
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Blood insulin
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Assessment method [1]
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insuin ELISA kit
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Timepoint [1]
431235
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Pre treatment (-10 minutes), Post treatment (+30 minutes, +60 minutes, +90 minutes, + 120 minutes, +150 minutes, +180 minutes)
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Eligibility
Key inclusion criteria
• 18 years or more
• Fasting blood glucose level between 3.9 mmol/L – 5.5 mmol/L
• Not taking medications that affect blood sugar ( e.g., diabetic medications)
• No gastrointestinal conditions that may affect glycaemic response (any gastrointestinal inflammatory and/or functional disease/disorder and/or recent gastro surgery)
• No health conditions that may affect participation (e.g., diabetes, cardiovascular disease, hypertension, liver or thyroid dysfunction or recent major surgery or have implanted cardiac defibrillator)
• Not a present or past cigarette smoker
• Able to adhere to the study protocol and consume every study food
• Available to attend five testing sessions at the Notting Hill BASE Facility
• Nor pregnant, planning on becoming pregnant or breastfeeding
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
None
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Crossover
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Date of first participant enrolment
Anticipated
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Actual
12/01/2023
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Date of last participant enrolment
Anticipated
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Actual
24/01/2023
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Date of last data collection
Anticipated
22/03/2024
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Actual
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Sample size
Target
12
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Accrual to date
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Final
13
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Recruitment in Australia
Recruitment state(s)
VIC
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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The Product Makers
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Address [1]
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Country [1]
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Australia
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Primary sponsor type
University
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Name
Monash University
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Address
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Country
Australia
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Secondary sponsor category [1]
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Government body
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Name [1]
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Department of Industry, Science and Resources: Innovations Connection Grant
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Address [1]
317816
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Country [1]
317816
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Australia
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Secondary sponsor category [2]
317841
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Commercial sector/Industry
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Name [2]
317841
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The Product Makers
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Address [2]
317841
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Country [2]
317841
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
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Monash University Human Research Ethics Committee
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Ethics committee address [1]
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https://www.monash.edu/researchoffice/ethics
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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02/08/2022
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Approval date [1]
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16/08/2022
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Ethics approval number [1]
314577
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Summary
Brief summary
Polyphenol-rich sugarcane extract (PRSE) is derived from sugarcane molasses. Polyphenols are naturally occurring substances in plants, known to reduce blood glucose levels. The aim of this study is to investigate the ability of PRSE to reduce blood glucose levels after eating a sandwich. We will investigate two doses of PRSE to find out the best concentration to reduce blood glucose levels of healthy people
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Prof Gary Williamson
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Address
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Victorian Heart Institute Room 2.79, Victoria Heart Hospital 631 Blackburn Road Clayton, VIC 3168
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Country
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Australia
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Phone
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+61399024270
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Fax
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Email
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[email protected]
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Contact person for public queries
Name
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Ulluwis Hewawansa
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Address
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Be Active Sleep Eat (BASE) Facility Monash University- Faculty of Medicine, Nursing and Health Sciences Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168, Australia
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Country
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Australia
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Phone
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+61 470407042
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Ulluwis Hewawansa
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Address
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Be Active Sleep Eat (BASE) Facility Monash University- Faculty of Medicine, Nursing and Health Sciences Level 1, 264 Ferntree Gully Road, Notting Hill, VIC 3168, Australia
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Country
132064
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Australia
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Phone
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+61 470407042
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Fax
132064
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Email
132064
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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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.
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