Clinical trial NCT04180787: Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance
Official title: Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exercise Performance
Metabolism
Lead sponsor: Texas Tech University
Sponsor class: OTHER
Collaborators: name: Vital Pharmaceuticals, Inc.
First posted: 2019-11-29
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Isometric Force Production
timeFrame: Assessed approximately 45 minutes after beverage ingestion
measure: Isometric Force Production
timeFrame: Assessed approximately 80 minutes after beverage ingestion
measure: Isokinetic Force Production
timeFrame: Assessed approximately 45 minutes after beverage ingestion
measure: Isokinetic Force Production
timeFrame: Assessed approximately 80 minutes after beverage ingestion
measure: Maximal Lower Body Strength
timeFrame: Assessed approximately 75 minutes after beverage ingestion
measure: Maximal Lower Body Endurance
timeFrame: Assessed approximately 75 minutes after beverage ingestion (following maximal lower body strength testing)
measure: Change in Metabolic Rate
timeFrame: Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
measure: Change in Metabolic Rate
timeFrame: Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing
measure: Change in Respiratory Exchange Ratio
timeFrame: Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
measure: Change in Respiratory Exchange Ratio
timeFrame: Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing.
Secondary outcomes:
Other outcomes:
Locations:
city: Lubbock
country: United States
facility: Department of Kinesiology & Sport Management
state: Texas
Study officials:
affiliation: Texas Tech University
name: Grant M Tinsley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.