Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance

Metabolism Clinical Trial

Official title:

Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04180787
• Other study ID #: 20-0130
• Status: Completed
• Phase: N/A
• Start date: December 5, 2019
• Est. completion date: March 9, 2020

Study information

• Verified date: May 2020
• Source: Texas Tech University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: March 9, 2020
• Est. primary completion date: March 9, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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)

Related Conditions & MeSH terms

• Exercise Performance
• Metabolism

Intervention

Dietary Supplement:
• Beverage Consumption
Participants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition.

Locations

Country	Name	City	State
United States	Department of Kinesiology & Sport Management	Lubbock	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Texas Tech University	Vital Pharmaceuticals, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Isometric Force Production	Isometric force production on mechanized squat device	Assessed approximately 45 minutes after beverage ingestion
Primary	Isometric Force Production	Isometric force production on mechanized squat device	Assessed approximately 80 minutes after beverage ingestion
Primary	Isokinetic Force Production	Isokinetic force production on mechanized squat device	Assessed approximately 45 minutes after beverage ingestion
Primary	Isokinetic Force Production	Isokinetic force production on mechanized squat device.	Assessed approximately 80 minutes after beverage ingestion
Primary	Maximal Lower Body Strength	One-repetition maximum on hip sled machine	Assessed approximately 75 minutes after beverage ingestion
Primary	Maximal Lower Body Endurance	Repetitions to failure on hip sled machine	Assessed approximately 75 minutes after beverage ingestion (following maximal lower body strength testing)
Primary	Change in Metabolic Rate	Metabolic rate assessed via indirect calorimetry	Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
Primary	Change in Metabolic Rate	Metabolic rate assessed via indirect calorimetry	Change in metabolic rate between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing
Primary	Change in Respiratory Exchange Ratio	Respiratory exchange ratio as assessed via indirect calorimetry	Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
Primary	Change in Respiratory Exchange Ratio	Respiratory exchange ratio as assessed via indirect calorimetry	Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing.