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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
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
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
Secondary ID [1] 311434 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes 332720 0
Condition category
Condition code
Metabolic and Endocrine 329438 329438 0 0
Diabetes

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 327877 0
Prevention
Comparator / control treatment
A placebo drink with equivalent amounts of sugars (sucrose, glucose, and fructose) to each dose will be used.
Control group
Placebo

Outcomes
Primary outcome [1] 337257 0
Change in postprandial blood glucose
Timepoint [1] 337257 0
Pre treatment (-10 minutes), Post treatment (+15 minutes, +30 minutes, +45 minutes, +60 minutes, +90 minutes, + 120 minutes, +150 minutes, +180 minutes)
Secondary outcome [1] 431235 0
Blood insulin
Timepoint [1] 431235 0
Pre treatment (-10 minutes), Post treatment (+30 minutes, +60 minutes, +90 minutes, + 120 minutes, +150 minutes, +180 minutes)

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
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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

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
Actual
12/01/2023
Date of last participant enrolment
Anticipated
Actual
24/01/2023
Date of last data collection
Anticipated
22/03/2024
Actual
Sample size
Target
12
Accrual to date
Final
13
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315711 0
Commercial sector/Industry
Name [1] 315711 0
The Product Makers
Country [1] 315711 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Country
Australia
Secondary sponsor category [1] 317816 0
Government body
Name [1] 317816 0
Department of Industry, Science and Resources: Innovations Connection Grant
Address [1] 317816 0
Country [1] 317816 0
Australia
Secondary sponsor category [2] 317841 0
Commercial sector/Industry
Name [2] 317841 0
The Product Makers
Address [2] 317841 0
Country [2] 317841 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314577 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314577 0
Ethics committee country [1] 314577 0
Australia
Date submitted for ethics approval [1] 314577 0
02/08/2022
Approval date [1] 314577 0
16/08/2022
Ethics approval number [1] 314577 0

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

Contacts
Principal investigator
Name 132062 0
Prof Gary Williamson
Address 132062 0
Victorian Heart Institute Room 2.79, Victoria Heart Hospital 631 Blackburn Road Clayton, VIC 3168
Country 132062 0
Australia
Phone 132062 0
+61399024270
Fax 132062 0
Email 132062 0
gary.williamson1@monash.edu
Contact person for public queries
Name 132063 0
Ulluwis Hewawansa
Address 132063 0
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
Country 132063 0
Australia
Phone 132063 0
+61 470407042
Fax 132063 0
Email 132063 0
ulluwis.hewawansa@monash.edu
Contact person for scientific queries
Name 132064 0
Ulluwis Hewawansa
Address 132064 0
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
Country 132064 0
Australia
Phone 132064 0
+61 470407042
Fax 132064 0
Email 132064 0
ulluwis.hewawansa@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.