NCT04180787

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 20, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 29, 2019

Completed
6 days until next milestone

Study Start

First participant enrolled

December 5, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2020

Completed
Last Updated

May 7, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

November 20, 2019

Last Update Submit

May 5, 2020

Conditions

Outcome Measures

Primary Outcomes (10)

  • Isometric Force Production

    Isometric force production on mechanized squat device

    Assessed approximately 45 minutes after beverage ingestion

  • Isometric Force Production

    Isometric force production on mechanized squat device

    Assessed approximately 80 minutes after beverage ingestion

  • Isokinetic Force Production

    Isokinetic force production on mechanized squat device

    Assessed approximately 45 minutes after beverage ingestion

  • Isokinetic Force Production

    Isokinetic force production on mechanized squat device.

    Assessed approximately 80 minutes after beverage ingestion

  • Maximal Lower Body Strength

    One-repetition maximum on hip sled machine

    Assessed approximately 75 minutes after beverage ingestion

  • Maximal Lower Body Endurance

    Repetitions to failure on hip sled machine

    Assessed approximately 75 minutes after beverage ingestion (following maximal lower body strength testing)

  • 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

  • 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

  • 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

  • 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.

Study Arms (2)

Keto Coffee

EXPERIMENTAL

VPX Bang® Keto Coffee beverage

Dietary Supplement: Beverage Consumption

Placebo

PLACEBO COMPARATOR

Flavor-matched placebo beverage

Dietary Supplement: Beverage Consumption

Interventions

Beverage ConsumptionDIETARY_SUPPLEMENT

Participants will consume either VPX Bang® Keto Coffee beverage or flavor-matched placebo beverage in each condition.

Keto CoffeePlacebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Kinesiology & Sport Management

Lubbock, Texas, 79409, United States

Location

Related Publications (1)

  • 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.

Study Officials

  • Grant M Tinsley, PhD

    Texas Tech University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2019

First Posted

November 29, 2019

Study Start

December 5, 2019

Primary Completion

March 9, 2020

Study Completion

March 9, 2020

Last Updated

May 7, 2020

Record last verified: 2020-05

Locations