Clinical trial NCT05061797: A Study to Examine the Effect of a Thermogenic Energy Drink in Healthy Adults
Official title: A Double-Blind, Randomized, Crossover Study to Examine the Thermogenic Effect of an Energy Drink in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Metabolism
Keywords: Thermogenic
Lead sponsor: Rowdy Energy
Sponsor class: INDUSTRY
Collaborators: name: Biofortis Clinical Research, Inc.
First posted: 2021-09-30
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Double-Blind, Randomized, Crossover Study
Primary purpose: PREVENTION

Brief summary: This study is intended to examine the acute thermogenic effects of the active study product (energy drink), in healthy adults.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

Generally healthy male or female, 18-50 years of age, inclusive.

* BMI of ≥18.0 and ≤30.0 kg/m2 at Visit 1 (Day -7).
* Non-user of all tobacco, smoking products (including, but not limited to cigarettes, cigars, chewing tobacco, e-cigarettes), and nicotine products (e.g., nicotine gum and/or nicotine patches) within 1 y of Visit 1 (Day -7) and has no plans to change status during the study period.
* Willing to maintain habitual diet and physical activity patterns throughout the trial.
* Willing and able to comply with the visit schedule.
* Willing to refrain from exclusionary medications, supplements, and products.
* No health conditions that would prevent him/her from fulfilling the study requirements as judged by the Clinical Investigator on the basis of medical history and routine laboratory test results.
* Understands the study procedures and signs forms providing informed consent to participate in the study and authorizes the release of relevant protected health information to the Clinical Investigator

Exclusion Criteria:

* Known allergy, intolerance, or sensitivity to any of the ingredients in the study product provided.
* Abnormal laboratory test results of clinical significance at Visit 1 (Day -7) at the discretion of the Clinical Investigator. One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects with abnormal laboratory test results.
* Use of hemp or marijuana products within 1 mo of Visit 1 (Day -7)
* Extreme dietary habits at the discretion of the Clinical Investigator.
* Currently or planning to be on a weight loss regimen during the study or use of weight-loss drugs (including over-the-counter medications and/or supplements, including thermogenic/fat-burning supplements) or participated in weight-loss programs within 3 mo of Visit 1 (Day -7).
* Chronic use of products that may affect metabolism (e.g., ephedrine alkaloids, guggulsterones, etc.) and/or muscle mass (i.e. creatine, protein/amino acids (including free and/or branched chain amino acid), androstenedione, dihydroepiandrosterone (DHEA), hydroxylmethylbutyrate, pre/post-workout supplements, etc.) within 3 mo of Visit 1 (Day -7). Non-chronic users (\<3 serving/week) must have a 2-wk washout prior to Visit 2 (Day 0).
* History or presence of clinically important endocrine (including hyper/hypo-parathyroidism, type 1 or 2 diabetes mellitus and/or hypoglycemia), cardiovascular (unstable angina pectoris or myocardial infarction, heart failure or cardiomyopathy (acute or chronic), coronary artery revascularization (PCI) or bypass surgery, malignant atrial or ventricular arrhythmia, valvular heart disease or congenital heart disease), pulmonary (including uncontrolled asthma), hepatic, renal (including chronic kidney disease), hematologic (including chronic anemia), immunologic, dermatologic, neurologic, rheumatic (including gout), biliary, polycystic ovarian syndrome, muscle diseases, and/or psychiatric disorders, that, in the opinion of the Clinical Investigator, could interfere with the interpretation of the study results.
* Hypertension (systolic blood pressure ≥140 mm Hg or diastolic blood pressure ≥90 mm Hg) as defined by the blood pressure measured at Visit 1 (Day -7). One re-test will be allowed on a separate day prior to Visit 2 (Day 0), for subjects whose blood pressure exceeds either of these cut points at Visit 1 (Day -7), in the judgment of the Clinical Investigator.
* Reports any clinically important gastrointestinal condition that would potentially interfere with the evaluation of the study product (e.g., inflammatory bowel disease, irritable bowel syndrome, short bowel syndrome, gastroparesis, celiac disease, intestinal dysmotility, active diverticulitis, or ischemic colitis, or any other related condition and subjects with uncontrolled severe diarrhea, nausea or vomiting from any cause, and history of surgery for weight loss), that, in the judgment of the Clinical Investigator, may have the potential to disrupt normal digestion and absorption.
* History or presence of cancer within 5 y of screening (Visit 1, Day -7), except for localized basal cell carcinoma and squamous cell carcinoma of the skin.
* History of active tuberculosis, HIV, AIDS, or Hepatitis-A, -B, and -C.
* Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source documentation.
* Recent history of (within 12 mo of screening; Visit 1; Day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).
* Exposure to any non-registered drug product within 30 d of Visit 1 (Day -7).
* Use of oral and intravenous antibiotics, antifungals, and antiparasitics within 3 mo of Visit 1 (Day -7). Topical use of antibiotics, antifungals, and antiparasitics will be at the discretion of the Clinical Investigator.
* Unstable use of birth control pills, intrauterine device, and vaginal rings within 3 mo of Visit1 (Day -7).
* Unstable use of inhaled steroids for asthma within 3 mo of Visit 1 (Day -7).
* Regular (daily) use of NSAIDs within 1 mo of Visit 1 (Day -7).
* Use of topical, optical or oral steroids within 1 mo of Visit 1 (Day -7).
* Use of medications known to affect hormones (including, but not limited to progestational agents, estrogen or estrogen receptor modulators, and growth hormone) within 1 mo of Visit1 (Day -7).
* Use of dronabinol within 1 mo of Visit 1 (Day -7).
* Use of metformin within 1 mo of Visit 1 (Day -7).
* Use of prescription strength anti-inflammatories within 48 h of Visit 1 (Day -1).
* Has a condition the Clinical Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results, or put the subject at undue risk.

Primary outcomes:
measure: Thermogenic Effect through REE (Resting Energy Expenditure)
timeFrame: Up to 12 weeks for all participants, 180 minutes per participant per session.
Secondary outcomes:
measure: Satiety (As Perceived by the Participant)
timeFrame: Up to 12 weeks for all participants, 180 minutes per participant per session.
measure: Side Effects/ Gastrointestinal Tolerance
timeFrame: Up to 12 weeks for all participants, 180 minutes per participant per session.
Other outcomes:
Locations:
city: Addison
country: United States
facility: Biofortis Clinical Research
state: Illinois
Study officials:
affiliation: BioFortis
name: Oliver Chen
role: STUDY_DIRECTOR
References:
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citation: 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.
citation: 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.
citation: 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.