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| Name | Class |
|---|---|
| Biofortis Clinical Research, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Study Product | Active Comparator | An energy beverage formulated to improve the thermogenic (calorie burning) impact in humans via caffeine and ingredients for overall metabolic wellness. |
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| Placebo | Placebo Comparator | A carbonated soft-drink with the same appearance, aroma, and flavor as the active study product |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Thermogenic Energy Drink - Active Study Product Formula | Dietary Supplement | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 12 weeks for all participants, 180 minutes per participant per session. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Generally healthy male or female, 18-50 years of age, inclusive.
Exclusion Criteria:
Target at least 50% of the participants as "Female." The balance would be male.
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| Name | Affiliation | Role |
|---|---|---|
| Oliver Chen | BioFortis | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Biofortis Clinical Research | Addison | Illinois | 60101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30400196 | Background | Amaro-Gahete FJ, Jurado-Fasoli L, De-la-O A, Gutierrez A, Castillo MJ, Ruiz JR. Accuracy and Validity of Resting Energy Expenditure Predictive Equations in Middle-Aged Adults. Nutrients. 2018 Nov 2;10(11):1635. doi: 10.3390/nu10111635. | |
| 7485480 | Background | Bracco D, Ferrarra JM, Arnaud MJ, Jequier E, Schutz Y. Effects of caffeine on energy metabolism, heart rate, and methylxanthine metabolism in lean and obese women. Am J Physiol. 1995 Oct;269(4 Pt 1):E671-8. doi: 10.1152/ajpendo.1995.269.4.E671. |
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Double-Blind, Randomized, Crossover Study
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Samples are coded with 3 digit, randomized codes. Active study product and placebo are not known to the administrators of the study or the participants.
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| Placebo | Dietary Supplement | 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). |
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| 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. | Up to 12 weeks for all participants, 180 minutes per participant per session. |
| 32054486 | Background | Clark NW, Wells AJ, Coker NA, Goldstein ER, Herring CH, Starling-Smith TM, Varanoske AN, Panissa VLG, Stout JR, Fukuda DH. The acute effects of thermogenic fitness drink formulas containing 140 mg and 100 mg of caffeine on energy expenditure and fat metabolism at rest and during exercise. J Int Soc Sports Nutr. 2020 Feb 13;17(1):10. doi: 10.1186/s12970-020-0341-4. |
| 16720129 | Background | Compher C, Frankenfield D, Keim N, Roth-Yousey L; Evidence Analysis Working Group. Best practice methods to apply to measurement of resting metabolic rate in adults: a systematic review. J Am Diet Assoc. 2006 Jun;106(6):881-903. doi: 10.1016/j.jada.2006.02.009. |
| 2912010 | Background | Dulloo AG, Geissler CA, Horton T, Collins A, Miller DS. Normal caffeine consumption: influence on thermogenesis and daily energy expenditure in lean and postobese human volunteers. Am J Clin Nutr. 1989 Jan;49(1):44-50. doi: 10.1093/ajcn/49.1.44. |
| 26038298 | Background | Fullmer S, Benson-Davies S, Earthman CP, Frankenfield DC, Gradwell E, Lee PS, Piemonte T, Trabulsi J. Evidence analysis library review of best practices for performing indirect calorimetry in healthy and non-critically ill individuals. J Acad Nutr Diet. 2015 Sep;115(9):1417-1446.e2. doi: 10.1016/j.jand.2015.04.003. Epub 2015 May 30. |
| 18035001 | Background | Thom E. The effect of chlorogenic acid enriched coffee on glucose absorption in healthy volunteers and its effect on body mass when used long-term in overweight and obese people. J Int Med Res. 2007 Nov-Dec;35(6):900-8. doi: 10.1177/147323000703500620. |