Exercise PerformanceNCT04180787
Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance
A study testing Beverage Consumption in people with Exercise Performance and Metabolism, run by Texas Tech University at 1 site in United States.
Trial summary
The purpose of this randomized, double-blind, crossover study is to investigate the effects of Bang® Keto Coffee on resting and post-exercise metabolism and muscular performance during lower body resistance exercise. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Performance, Metabolism
- What is being tested?
- Beverage Consumption
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2019to 9 Mar 2020
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between the ages of 18 and 40
- Generally healthy (defined as an absence of any disease or medical condition which could potentially be negatively affected by consumption of the commercially available dietary supplement of performance of exercise, including but not limited to musculoskeletal or cardiovascular diseases).
- Resistance-trained, defined as completing 3+ resistance training sessions per week for at least one year and including at least weekly training of the lower body through a multi-joint exercise such as the squat or leg press.
- Regular caffeine consumption, defined as an average self-reported daily intake of 200+ mg of caffeine, which is equivalent to approximately 2 cups of coffee.
Who cannot join
- Failing to meet any of the aforementioned inclusion criteria.
- Pregnant or breastfeeding (for female participants)
- Taking prescription medication which could reasonably make participation unsafe for the participant or influence study outcomes
- An inability to complete lower body resistance exercise due to injury or medical condition
- Self-reported caffeine sensitivity, as indicated by unwanted side effects when caffeine is consumed.
- Allergy to any of the ingredients in the commercially available dietary supplement
- Self-reported claustrophobia (due to metabolism testing)
Trial locations and contacts
1 site in 1 country.
United States1 site
Department of Kinesiology & Sport Management
Lubbock, Texas, 79409
About this study
The purpose of this randomized, double-blind, crossover study is to investigate the effects of Bang® Keto Coffee on resting and post-exercise metabolism and muscular performance during lower body resistance exercise.
Read the detailed description
Resistance-trained males and females will be recruited for participation in a randomized, double-bind, crossover trial. After providing informed consent, each participant will undergo a familiarization session to become accustomed to the study procedures. Following familiarization, each participant will complete two laboratory visits consisting of metabolism and exercise performance assessments. In both visits, a baseline assessment of resting metabolic rate (RMR) and respiratory exchange ratio (RER) will be conducted using indirect calorimetry. Following the initial RMR assessment, each participant will ingest a coffee flavored beverage, either VPX Bang® Keto Coffee or a flavor-matched placebo. After beverage consumption, the participant will return to the supine position and rest prior to initiation of the second RMR assessment. Immediately following the second RMR assessment, the participant will begin a 5-minute dynamic bodyweight warm up. Participants will then begin squat testing procedures on a mechanized squat device. After completing the squat testing, participants will complete a standard 1-repetition maximum and repetitions to failure using a plate-loaded hip sled machine. Following the hip sled testing, participants will repeat the mechanized squat testing. Following completion of the exercise testing, a third and final RMR assessment will be performed. Following successful completion of the first condition, each participant will enter a wash out period, after which the visit will be repeated with ingestion of the alternative beverage.
- Conditions
- Exercise Performance, Metabolism
- Being tested
- Beverage Consumption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage ConsumptionDietary supplement
Participants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition.
| Study group | Role | What they receive |
|---|---|---|
| Keto Coffee | Experimental | VPX Bang® Keto Coffee beverage Receives: Dietary Supplement: Beverage Consumption |
| Placebo | Placebo comparator | Flavor-matched placebo beverage Receives: Dietary Supplement: Beverage Consumption |
What is being measured
The primary outcome is the main question the study is designed to answer.
Isometric Force Production
Isometric force production on mechanized squat device
Measured: Assessed approximately 45 minutes after beverage ingestion
Isometric Force Production
Isometric force production on mechanized squat device
Measured: Assessed approximately 80 minutes after beverage ingestion
Isokinetic Force Production
Isokinetic force production on mechanized squat device
Measured: Assessed approximately 45 minutes after beverage ingestion
Isokinetic Force Production
Isokinetic force production on mechanized squat device.
Measured: Assessed approximately 80 minutes after beverage ingestion
Maximal Lower Body Strength
One-repetition maximum on hip sled machine
Measured: Assessed approximately 75 minutes after beverage ingestion
Maximal Lower Body Endurance
Repetitions to failure on hip sled machine
Measured: Assessed approximately 75 minutes after beverage ingestion (following maximal lower body strength testing)
Change in Metabolic Rate
Metabolic rate assessed via indirect calorimetry
Measured: Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
Change in Metabolic Rate
Metabolic rate assessed via indirect calorimetry
Measured: Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing
Change in Respiratory Exchange Ratio
Respiratory exchange ratio as assessed via indirect calorimetry
Measured: Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
Change in Respiratory Exchange Ratio
Respiratory exchange ratio as assessed via indirect calorimetry
Measured: Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2019
- Study start5 Dec 2019
- Primary completion9 Mar 2020
- Study completion9 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Exercise PerformanceStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Tech University
- Sponsor type
- University, hospital or other
- Collaborators
- Vital Pharmaceuticals, Inc.
- Responsible party
- Sponsor
- Investigators
- Grant M Tinsley, PhD, Principal investigator, Texas Tech University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04180787
- Sponsor's protocol ID
- 20-0130
- Status last verified
- May 2020
- First submitted
- 20 Nov 2019
- Last updated
- 7 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Harty PS, Stratton MT, Escalante G, Rodriguez C, Dellinger JR, Williams AD, White SJ, Smith RW, Johnson BA, Sanders MB, Tinsley GM. Effects of Bang(R) Keto Coffee Energy Drink on Metabolism and Exercise Performance in Resistance-Trained Adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study. J Int Soc Sports Nutr. 2020 Aug 24;17(1):45. doi: 10.1186/s12970-020-00374-5.
PubMed 32831109
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance
- ClinicalTrials.gov ID
- NCT04180787
- Acronym / sponsor ID
- 20-0130
- Conditions
- Exercise Performance, Metabolism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Texas Tech UniversityUniversity, hospital or other
- Collaborators
- Vital Pharmaceuticals, Inc.
- Study start
- 5 Dec 2019 (actual)
- Primary completion
- 9 Mar 2020 (actual)
- Study completion
- 9 Mar 2020 (actual)
- First posted
- 29 Nov 2019 (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.
The purpose of this randomized, double-blind, crossover study is to investigate the effects of Bang® Keto Coffee on resting and post-exercise metabolism and muscular performance during lower body resistance exercise.
Detailed description
Resistance-trained males and females will be recruited for participation in a randomized, double-bind, crossover trial. After providing informed consent, each participant will undergo a familiarization session to become accustomed to the study procedures. Following familiarization, each participant will complete two laboratory visits consisting of metabolism and exercise performance assessments. In both visits, a baseline assessment of resting metabolic rate (RMR) and respiratory exchange ratio (RER) will be conducted using indirect calorimetry. Following the initial RMR assessment, each participant will ingest a coffee flavored beverage, either VPX Bang® Keto Coffee or a flavor-matched placebo. After beverage consumption, the participant will return to the supine position and rest prior to initiation of the second RMR assessment. Immediately following the second RMR assessment, the participant will begin a 5-minute dynamic bodyweight warm up. Participants will then begin squat testing procedures on a mechanized squat device. After completing the squat testing, participants will complete a standard 1-repetition maximum and repetitions to failure using a plate-loaded hip sled machine. Following the hip sled testing, participants will repeat the mechanized squat testing. Following completion of the exercise testing, a third and final RMR assessment will be performed. Following successful completion of the first condition, each participant will enter a wash out period, after which the visit will be repeated with ingestion of the alternative beverage.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keto Coffee | Experimental | Dietary Supplement: Beverage ConsumptionVPX Bang® Keto Coffee beverage |
| Placebo | Placebo comparator | Dietary Supplement: Beverage ConsumptionFlavor-matched placebo beverage |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Between the ages of 18 and 40
- Generally healthy (defined as an absence of any disease or medical condition which could potentially be negatively affected by consumption of the commercially available dietary supplement of performance of exercise, including but not limited to musculoskeletal or cardiovascular diseases).
- Resistance-trained, defined as completing 3+ resistance training sessions per week for at least one year and including at least weekly training of the lower body through a multi-joint exercise such as the squat or leg press.
- Regular caffeine consumption, defined as an average self-reported daily intake of 200+ mg of caffeine, which is equivalent to approximately 2 cups of coffee.
Key exclusion criteria (7 listed)
- Failing to meet any of the aforementioned inclusion criteria.
- Pregnant or breastfeeding (for female participants)
- Taking prescription medication which could reasonably make participation unsafe for the participant or influence study outcomes
- An inability to complete lower body resistance exercise due to injury or medical condition
- Self-reported caffeine sensitivity, as indicated by unwanted side effects when caffeine is consumed.
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 |
|---|---|---|
| Beverage ConsumptionParticipants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition. | Dietary supplement | Keto Coffee, Placebo |
Primary outcome
Isometric Force Production
Time frame: Assessed approximately 45 minutes after beverage ingestion
Isometric force production on mechanized squat device
Isometric Force Production
Time frame: Assessed approximately 80 minutes after beverage ingestion
Isometric force production on mechanized squat device
Isokinetic Force Production
Time frame: Assessed approximately 45 minutes after beverage ingestion
Isokinetic force production on mechanized squat device
Isokinetic Force Production
Time frame: Assessed approximately 80 minutes after beverage ingestion
Isokinetic force production on mechanized squat device.
Maximal Lower Body Strength
Time frame: Assessed approximately 75 minutes after beverage ingestion
One-repetition maximum on hip sled machine
Maximal Lower Body Endurance
Time frame: Assessed approximately 75 minutes after beverage ingestion (following maximal lower body strength testing)
Repetitions to failure on hip sled machine
Change in Metabolic Rate
Time frame: Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
Metabolic rate assessed via indirect calorimetry
Change in Metabolic Rate
Time frame: Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing
Metabolic rate assessed via indirect calorimetry
Change in Respiratory Exchange Ratio
Time frame: Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
Respiratory exchange ratio as assessed via indirect calorimetry
Change in Respiratory Exchange Ratio
Time frame: Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing.
Respiratory exchange ratio as assessed via indirect calorimetry
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 7 May 2020.
- Derived from this study: PubMed 32831109Harty PS, Stratton MT, Escalante G, Rodriguez C, Dellinger JR, Williams AD, White SJ, Smith RW, Johnson BA, Sanders MB, Tinsley GM. Effects of Bang(R) Keto Coffee Energy Drink on Metabolism and Exercise Performance in Resistance-Trained Adults: A Randomized, Double-blind, Placebo-controlled, Crossover Study. J Int Soc Sports Nutr. 2020 Aug 24;17(1):45. doi: 10.1186/s12970-020-00374-5.
- Individual participant dataSharing planned: Undecided
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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.
Grant M Tinsley, PhD principal investigator
Texas Tech University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage Consumption in people with Exercise Performance and Metabolism, run by Texas Tech University 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 4 inclusion and 7 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 7 May 2020. 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?
Isometric Force Production (time frame: Assessed approximately 45 minutes after beverage ingestion). The study lists 10 primary outcomes in all. 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 NCT04180787, which also lists 1 linked publication.
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 7 May 2020.