A Study to See if an Energy Drink With Caffeine and Green Tea Increases Fat Burning When Exercising

This study investigates whether consuming an energy drink containing caffeine and green tea extract before exercise increases fat burning (oxidation) compared with a placebo drink. Healthy, moderately active adults will attend three visits at clinic over 3-5 weeks. The first visit determines each participant's individual exercise intensity that maximises fat use during cycling. At two subsequent visits, participants will consume either the active drink or a placebo before completing a 30-minute cycling session at their personalised intensity. Fat and carbohydrate use, heart rate, blood pressure, and subjective responses will be measured at rest, during exercise, and after exercise using a double-blind, crossover design.

• Active (Green tea and caffeine) (Dietary supplement), also known as XS Energy + BURN: Two 355 mL cans of "XS Energy + BURN" drink containing caffeine and green tea extract.
• Placebo (Other): Two 355 mL cans of placebo drink but without the active ingredients (caffeine and green tea extract).

Primary outcomes

• Fat oxidation as measured by indirect calorimetry [Baseline to 30 mins post exercise]: Change from baseline to the end of the study period in Fat oxidation as measured by indirect calorimetry (metabolic cart); baseline (pre-drink), post-drink (pre-exercise), time sequence e.g., every 5-min during exercise, 10, 20 and 30-min post-exercise. Change from baseline \& total. Fat oxidation will be measured continuously throughout the exercise and the 30-min post-exercise window, to facilitate total, and any other temporal fat oxidation timepoints.

Secondary outcomes

• Carbohydrate oxidation; indirect calorimetry [Baseline to 30 mins post exercise]: Change from baseline to the end of the study period in Carbohydrate oxidation; indirect calorimetry; same timing as fat oxidation (baseline (pre-drink), post-drink (pre-exercise), time sequence e.g., every 5-min during exercise, 10, 20 and 30-min post-exercise.). Change from baseline \& total.
• Respiratory exchange ratio; indirect calorimetry [Baseline to 30 mins post exercise]: Change from baseline to the end of the study period in Respiratory exchange ratio; indirect calorimetry; same timing as fat oxidation (baseline (pre-drink), post-drink (pre-exercise), time sequence e.g., every 5-min during exercise, 10, 20 and 30-min post-exercise). Change from baseline \& total
• Exercise efficiency; indirect calorimetry [Baseline to 30 mins post exercise]: Change from baseline to the end of the study period in Exercise efficiency; indirect calorimetry; time sequence during exercise e.g., every 5-min. Change from the beginning of exercise \& average

Other outcomes

• Tertiary: Compliance monitoring [Baseline to end of study period (week 5)]: Compliance monitoring for adherence to clinical trial components e.g. consumed volume of investigational product; ability to complete the necessary duration (30 mins) and intensity (at fat max) of exercise; adherence to immediate pre-trial control procedures of no caffeine or green tea extract in the 12 hours leading up to the experimental, arrival at the laboratory after an overnight fast
• Tertiary: Adverse Event monitoring [Baseline to end of study period (week 5)]: Adverse events will be monitored throughout the study across the study periods.
• Tertiary: Perceived gastrointestinal (dis)comfort questionnaire [Baseline to end of study (week 5)]: Change from baseline to the end of the study period in Perceived gastrointestinal (dis)comfort; measured via a questionnaire.
• Tertiary: Perceived satiety / hunger [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in Perceived satiety / hunger; measured via questionnaire.
• Tertiary: Perceived exercising exertion [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in Perceived exercising exertion; measured via questionnaire.
• Tertiary: heart rate [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in heart rate. Pre, during and post exercise heart rate.
• Tertiary: blood pressure [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in blood pressure. Pre, during and post exercise blood pressure.
• Tertiary: Safety via AE monitoring [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in safety via AE monitoring.
• Tertiary: Anthropometry - BMI [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in BMI.
• Tertiary: Anthropometry - weight [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in weight.
• Tertiary: Anthropometry - waist circumference [Baseline to end of study period (week 5)]: Change from baseline to the end of the study period in waist circumference.

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

Inclusion Criteria:

* Passing the Exercise and Sport Science Australia adult pre-exercise screening system (APSS) stage 1 \& 2 (see appendix 4).
* Between the ages of 18 and 45,
* Not sedentary, and not completing more than 150 minutes of low and/or moderate and/or or vigorous intensity endurance exercise a week,
* Ability to commit to in principle fulfilment of all 3 trial visits,
* No history of coagulopathy e.g., DVT, stroke,
* No known heart disease,
* No known pancreatic insufficiency,
* No known inflammatory bowel disease, or prior bowel resection or bypass surgery (excluding gastric banding and sleeve),
* BMI of 22.0 to 34.9 kg/m2,
* No known allergies to caffeine or green tea extract,
* No known type I or II diabetes,
* No uncontrolled concurrent illness,
* No known current pregnancy or breastfeeding women
* No current regular consumption of supplements (>2 times a week) or foods and drinks containing caffeine and/or green tea extracts (>2 times per day, weekly).
* Agree not to consume caffeine for 12-hours prior to the clinic visit.

Exclusion Criteria:

* Triggering any of the exclusion screening criteria as outlined below, and in compliment with the Exercise and Sport Science Australia adult pre-exercise screening system (APSS).
* Under the age of 18 or over the age of 45,
* Sedentary, or completing over 150 minutes of low and/or moderate and/or or vigorous intensity endurance exercise a week,
* Inability to commit to in principle fulfilment of all 3 trial visits,
* History of coagulopathy e.g., DVT, stroke,
* Known heart disease,
* Known pancreatic insufficiency,
* Known inflammatory bowel disease, or prior bowel resection or bypass surgery (excluding gastric banding and sleeve),
* BMI < 22.0 or > 34.9 kg/m2,
* Known allergies to caffeine or green tea extract,
* Known type I or II diabetes,
* Uncontrolled concurrent illness,
* Taking GLP-1 agonists, caffeine, or any other medication known to affect metabolism.
* Known current pregnancy or breastfeeding women.
* Currently regularly consuming supplements, foods or drinks containing a caffeine and green tea extract blend, or not willing to abstain for the study