None listed
Conditions
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
Interventions
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 consumpt
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.
Sponsors
Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Prevention
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Exclusion criteria
None
Outcome results
None listed