Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000285550
Ethics application status
Approved
Date submitted
24/01/2024
Date registered
20/03/2024
Date last updated
20/03/2024
Date data sharing statement initially provided
20/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effect of a Polyphenol Rich Sugarcane Extract also known as PRSE containing beverage or gel on exercise induced inflammation and gastrointestinal symptoms in response to heat stress in athletes
Scientific title
Effect of a Polyphenol Rich Sugarcane Extract containing beverage or gel on exercise induced inflammatory response and gastrointestinal symptoms in response to exertional heat stress in endurance trained active individuals
Secondary ID [1] 311362 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Exercise-induced gastrointestinal syndrome 332627 0
Condition category
Condition code
Oral and Gastrointestinal 329333 329333 0 0
Inflammatory bowel disease
Diet and Nutrition 329586 329586 0 0
Other diet and nutrition disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will be a Polyphenol-Rich Sugarcane Extract (PRSE) in a sports beverage. PRSE is a polyphenol-rich extract of sugarcane molasses. This beverage will be provided for 2 weeks to the subject. The dose is 10% w/v and subjects will receive 540 mL per day (2 X 270 mL, one at AM one at PM) during the intervention time. At the end of intervention time the participants will be subjected to a heat stress trial where they will run in 35 degrees of Celsius for 2 hours at 60% maximum volitional effort. During the intervention time the participants can continue with their daily routine. On the last day of intervention (the day before the exercise trial) they will be required to adhere to a low FODMAP diet for 24 hours and during the breakfast of the exercise trial day. During this trial they will be receiving 1 bottle (270 mL) of treatment drink pre-exercise at 0 minutes and PRSE containing gel packs every 20 minutes with 160 mL of water until 80 minutes. At 90 minutes they will receive a dual sugar drink consisting of 10 g of lactulose and 2 g of rhamnose along with 150 mL of water. During this protocol we will collect faecal samples and blood samples to measure biomarkers. i.e., Cortisol, Intestinal Fatty Acid Binding Protein (I-FABP), Interleukin (IL)-1ß, IL-1ra, Tumour Necrosis Factor alpha (TNF-a), IL-6, IL-8, and IL-10, sCD14, Short Chain Fatty Acids (SCFA) in faecal matter and plasma, metabolomics, Blood Glucose (BG), plasma bacterial DNA concentration, total and differential leukocyte cell count, plasma osmolality. The adherence to the protocol will be confirmed by self-reporting. The washout period between two treatments will be 2 weeks.
Intervention code [1] 327804 0
Treatment: Other
Comparator / control treatment
Sports beverage formulated similar to the drink mentioned above without Polyphenol-Rich Sugarcane Extract. This beverage will be provided for 2 weeks to the subject and the control group will be the same participants who received the treatment.
Control group
Placebo

Outcomes
Primary outcome [1] 337210 0
The composite primary outcome is to see any changes in exercise induced gastrointestinal disturbances and immune response.
Timepoint [1] 337210 0
Two weeks after the start of each treatment.
Secondary outcome [1] 431080 0
Any changes in short chain fatty acid composition and quantities in plasma and faecal matter.
Timepoint [1] 431080 0
Two weeks after the start of each treatment.

Eligibility
Key inclusion criteria
• 18 years or more but less than 49 years.
• Endurance trained individual
• Minimum capacity of VO2 max of 45 mL/kg/min
• No health conditions that may affect participation (e.g., diabetes, cardiovascular disease, hypertension, liver or thyroid dysfunction, or recent major surgery or implanted cardiac defibrillator).
• Not a smoker or vaper.
• Able to adhere to the study protocol and consume every study food.
• Available to attend three testing sessions at the Notting Hill BASE Facility.
• Not pregnant, planning on becoming pregnant, or breastfeeding.
• Not an individual presenting a clinical diagnosis of gastrointestinal disease or disorders or an individual presenting any other forms of illness or infection due to confounding effects on gastrointestinal markers/outcomes.
• No history of gastrointestinal surgery, and/or other self-reported gastrointestinal issues, consume potential modifiers of gastrointestinal integrity (such as prebiotics, probiotics, and/or antibiotics), adhering to gastrointestinal-focused dietary regimes (such as low FODMAP or fibre-modified diets) within previous 3 months of study.
• No consumption of non-steroidal anti-inflammatory medications and/or stool-altering medications (e.g., laxatives and anti-diarrhoea) within one month before the experimental protocol.
• Not an individual presenting soft tissues injury one month prior to participation due to risk of re-occurrence of injury.
Minimum age
18 Years
Maximum age
49 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
None

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)
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 receiving the treatment/s
The people administering the treatment/s

The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/04/2024
Actual
Date of last participant enrolment
Anticipated
1/07/2024
Actual
Date of last data collection
Anticipated
30/08/2024
Actual
Sample size
Target
12
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 315622 0
Commercial sector/Industry
Name [1] 315622 0
The Product Makers
Country [1] 315622 0
Australia
Funding source category [2] 316034 0
Government body
Name [2] 316034 0
Department of Industry, Science and Resources: Innovations Connection Grant
Country [2] 316034 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
The Product Makers
Address
Country
Australia
Secondary sponsor category [1] 317714 0
None
Name [1] 317714 0
Address [1] 317714 0
Country [1] 317714 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314504 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 314504 0
Room 111, Chancellery Building D, 26 Sports Walk, Clayton Campus Research Office Monash University VIC 3800
Ethics committee country [1] 314504 0
Australia
Date submitted for ethics approval [1] 314504 0
08/06/2023
Approval date [1] 314504 0
07/07/2023
Ethics approval number [1] 314504 0

Summary
Brief summary
Exercise induced stress is common amongst many activities within health care, security, industry and sport. It has consistently been associated with increased inflammation, gastrointestinal disturbances, gastrointestinal symptoms and loss of appetite, resulting in an inability to maintain work-output and/or withdrawal from activity; constituting both a productivity and financial burden. The mechanism responsible for exercise-induced inflammation, and gastrointestinal symptoms appears to be multi-factorial in origin, but ultimately leads to gut surface damage and leakage, and an overall reduction in food and fluid intake. Increased gut leakage during exercise has also previously been linked to subclinical symptoms, heat illnesses, and other clinical manifestations such as exercise-associated bacteraemia.

PRSE is a polyphenol-rich extract of sugarcane molasses. Polyphenols are naturally occurring substances in plants, known for their potential health benefits. We will explore the ability of PRSE to reduce exercise-associated gastrointestinal disturbances, including
symptomology.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 131822 0
A/Prof Ricardo Da Costa
Address 131822 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 131822 0
Australia
Phone 131822 0
+61 399056861
Fax 131822 0
Email 131822 0
ricardo.costa@monash.edu
Contact person for public queries
Name 131823 0
Ulluwis Hewawansa
Address 131823 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 131823 0
Australia
Phone 131823 0
+61 470407042
Fax 131823 0
Email 131823 0
ulluwis.hewawansa@monash.edu
Contact person for scientific queries
Name 131824 0
Ricardo Da Costa
Address 131824 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 131824 0
Australia
Phone 131824 0
+61 399056861
Fax 131824 0
Email 131824 0
ricardo.costa@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
As this is an industry funded project it will be not available as per the confidentiality agreement between the industry and university.


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.