- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04180787
Effects of a Caffeine- and Protein-Containing Coffee Beverage on Metabolism and Muscular Performance
May 5, 2020 updated by: Texas Tech University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
19
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Texas
-
Lubbock, Texas, United States, 79409
- Department of Kinesiology & Sport Management
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Keto Coffee
VPX Bang® Keto Coffee beverage
|
Participants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition.
|
Placebo Comparator: Placebo
Flavor-matched placebo beverage
|
Participants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Isometric Force Production
Time Frame: Assessed approximately 45 minutes after beverage ingestion
|
Isometric force production on mechanized squat device
|
Assessed approximately 45 minutes after beverage ingestion
|
Isometric Force Production
Time Frame: Assessed approximately 80 minutes after beverage ingestion
|
Isometric force production on mechanized squat device
|
Assessed approximately 80 minutes after beverage ingestion
|
Isokinetic Force Production
Time Frame: Assessed approximately 45 minutes after beverage ingestion
|
Isokinetic force production on mechanized squat device
|
Assessed approximately 45 minutes after beverage ingestion
|
Isokinetic Force Production
Time Frame: Assessed approximately 80 minutes after beverage ingestion
|
Isokinetic force production on mechanized squat device.
|
Assessed approximately 80 minutes after beverage ingestion
|
Maximal Lower Body Strength
Time Frame: Assessed approximately 75 minutes after beverage ingestion
|
One-repetition maximum on hip sled machine
|
Assessed approximately 75 minutes after beverage ingestion
|
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
|
Assessed approximately 75 minutes after beverage ingestion (following maximal lower body strength testing)
|
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 between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
|
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 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
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 between: 1) before beverage ingestion (baseline) and 2) beginning approximately 10 minutes after completion of beverage ingestion
|
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
|
Change in respiratory exchange ratio between: 1) before beverage ingestion (baseline) and 2) beginning approximately 5 minutes after completion of all exercise testing.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 5, 2019
Primary Completion (Actual)
March 9, 2020
Study Completion (Actual)
March 9, 2020
Study Registration Dates
First Submitted
November 20, 2019
First Submitted That Met QC Criteria
November 25, 2019
First Posted (Actual)
November 29, 2019
Study Record Updates
Last Update Posted (Actual)
May 7, 2020
Last Update Submitted That Met QC Criteria
May 5, 2020
Last Verified
May 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- 20-0130
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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