This study is intended to examine the acute thermogenic effects of the active study product (energy drink), in healthy adults.
The active study product and a control will be blinded with 3 digit codes. Human subjects will consume the coded products in a randomized manner. Measurements of rest energy expenditure via respiration will be performed throughout a 3 hour time span with controlled intervention an observation. Additional metrics will be gathered relating to benefits and/or side effects. The data gathered will be used to calculate the thermogenic impact of the active study product on healthy adults. The study is designed based on statistical confidence, with a minimum required number of active participants set to 26. 30 participants will be recruited.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
30
The Thermogenic Energy Drink is the Active Study Product (ASP). This energy drink formula combines, caffeine, guarana, Vitamins C, B3, B6, B12, Magnesium, Potassium, L-Citrulline, L-Arginine HCl, L-Glutamine, and Chlorogenic Acids from green coffee bean extract. Participants will consume an assigned amount of the beverage (355 ml), under observation. They will be monitored for the following 180 minutes with measurements of respiration for Resting Energy Expenditure (RER) and other metabolic markers as well as satiety via Visual Analog Scale (VAS).
A carbonated soft drink with the same appearance, flavor and aroma as the active study product. Study participants will consume an assigned amount of the beverage (355 ml) under observation. They will then be monitored for the subsequent 180 minutes with measurements for respiration for Resting Energy Expenditure (RER) and other metabolic markers as well as satiety via a Visual Analog Scale (VAS).
Biofortis Clinical Research
Addison, Illinois, United States
Thermogenic Effect through REE (Resting Energy Expenditure)
The quantified Thermogenic Impact of the ASP as measured from Resting Energy Expenditure testing with human participants following consumption of the ASP Thermogenic Energy Beverage. This is done via the difference in the net-incremental area under the curve (AUC) for the ASP Thermogenic Beverage vs. the Placebo. A larger difference in REE between the ASP Thermogenic Beverage and the Placebo indicates a greater Thermogenic (calorie expending) effect from the ASP Thermogenic Beverage.
Time frame: Up to 12 weeks for all participants, 180 minutes per participant per session.
Satiety (As Perceived by the Participant)
A qualitative review of satiety experienced by study participants using a Visual Analog Scale (VAS). The VAS is measured on a scale of 0 to 100, where 0 indicates no appetite and increasing values indicating higher appetite sensations. The VAS is designed to have participants assess their hunger, desire to eat, and fullness during the 180 minute time span of the test. Lower numerical scores for appetite would indicate improved satiety.
Time frame: Up to 12 weeks for all participants, 180 minutes per participant per session.
Side Effects/ Gastrointestinal Tolerance
A qualitative assessment of GI (Gastrointestinal Tolerance) The Participants will complete a Gastrointestinal Tolerance Questionnaire where they will asses and evaluate their symptoms on a scale from 0 to 3, with 0 indicating no experience of the symptom and 3 indicating a severe experience of the symptom. These will include Gat/flatulence, Abdominal Bloating, Abdominal Pain/ Discomfort, Borborygmus/ stomach rumbling, Burping, Reflux, Nausea, Vomiting. Lower scores for all symptoms would indicate that the Thermogenic Energy Drink ASP is well-tolerated.
Time frame: Up to 12 weeks for all participants, 180 minutes per participant per session.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.