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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12624000285550
Enrollment
12
Registered
2024-03-20
Start date
2024-04-01
Completion date
2024-07-01
Last updated
2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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 volitio

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.

Sponsors

The Product Makers
Lead SponsorCommercial sector/Industry

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
All
Age
18 Years to 49 Years
Healthy volunteers
Yes

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.

Exclusion criteria

None

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026