MetabolismNCT05061797
A Study to Examine the Effect of a Thermogenic Energy Drink in Healthy Adults
A study testing Thermogenic Energy Drink - Active Study Product Formula in people with Metabolism, run by Rowdy Energy at 1 site in United States.
Trial summary
This study is intended to examine the acute thermogenic effects of the active study product (energy drink), in healthy adults. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Metabolism
- What is being tested?
- Thermogenic Energy Drink - Active Study Product Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 16 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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).
Show all 24Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Biofortis Clinical Research
Addison, Illinois, 60101
About this study
Official title: A Double-Blind, Randomized, Crossover Study to Examine the Thermogenic Effect of an Energy Drink in Healthy Adults
This study is intended to examine the acute thermogenic effects of the active study product (energy drink), in healthy adults.
Read the 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.
- Conditions
- Metabolism
- Being tested
- Thermogenic Energy Drink - Active Study Product Formula, Placebo
- Keywords
- Thermogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thermogenic Energy Drink - Active Study Product FormulaDietary supplement
Also called Energy Drink - Rowdy Energy
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).
PlaceboDietary 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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Thermogenic Energy Drink - Active Study Product Formula |
| Placebo | Placebo comparator | A carbonated soft-drink with the same appearance, aroma, and flavor as the active study product Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 weeks for all participants, 180 minutes per participant per session.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Up to 12 weeks for all participants, 180 minutes per participant per session.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start23 Aug 2021
- Primary completion11 Oct 2021
- Study completion16 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for MetabolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Double-Blind, Randomized, Crossover Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rowdy Energy
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Responsible party
- Sponsor
- Investigators
- Oliver Chen, Study director, BioFortis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05061797
- Sponsor's protocol ID
- Energy Drink in HealthBIO-2113
- Status last verified
- Apr 2022
- First submitted
- 30 Aug 2021
- Last updated
- 2 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30400196Bracco 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.
PubMed 7485480Clark 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.
PubMed 32054486Compher 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.
PubMed 16720129Dulloo 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.
PubMed 2912010Fullmer 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.
PubMed 26038298Thom 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.
PubMed 18035001
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-Blind, Randomized, Crossover Study to Examine the Thermogenic Effect of an Energy Drink in Healthy Adults
- ClinicalTrials.gov ID
- NCT05061797
- Acronym / sponsor ID
- Energy Drink in HealthBIO-2113
- Conditions
- Metabolism
- Keywords
- Thermogenic
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Rowdy EnergyIndustry (pharma, biotech, devices)
- Collaborators
- Biofortis Clinical Research, Inc.
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 11 Oct 2021 (actual)
- Study completion
- 16 Nov 2021 (actual)
- First posted
- 30 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-Blind, Randomized, Crossover Study
| Arm | Type | Receives |
|---|---|---|
| Active Study Product | Active comparator | Dietary Supplement: Thermogenic Energy Drink - Active Study Product FormulaAn energy beverage formulated to improve the thermogenic (calorie burning) impact in humans via caffeine and ingredients for overall metabolic wellness. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboA carbonated soft-drink with the same appearance, aroma, and flavor as the active study product |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (24 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thermogenic Energy Drink - Active Study Product FormulaAlso: Energy Drink - Rowdy EnergyThe 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). | Dietary supplement | Active Study Product |
| PlaceboA 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). | Dietary supplement | Placebo |
Primary outcome
Thermogenic Effect through REE (Resting Energy Expenditure)
Time frame: Up to 12 weeks for all participants, 180 minutes per participant per session.
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.
2 secondary outcomes
Satiety (As Perceived by the Participant)
Time frame: Up to 12 weeks for all participants, 180 minutes per participant per session.
Side Effects/ Gastrointestinal Tolerance
Time frame: Up to 12 weeks for all participants, 180 minutes per participant per session.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2022.
- Background: PubMed 30400196Amaro-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.
- Background: PubMed 7485480Bracco 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.
- Background: PubMed 32054486Clark 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.
- Background: PubMed 16720129Compher 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.
- Background: PubMed 2912010Dulloo 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.
- Background: PubMed 26038298Fullmer 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.
- Background: PubMed 18035001Thom 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.
- Individual participant dataSharing planned: No
Related trials for Metabolism
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Chen study director
BioFortis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermogenic Energy Drink - Active Study Product Formula in people with Metabolism, run by Rowdy Energy at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thermogenic Effect through REE (Resting Energy Expenditure) (time frame: Up to 12 weeks for all participants, 180 minutes per participant per session.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05061797, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 May 2022.