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Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism

Primary Purpose

Caffeine, Diet, Healthy, Fat Burn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fitness Drink Formula
Sponsored by
University of Central Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Caffeine

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Young adult men and women between the ages of 18 and 35 years old.
  • Participant is deemed by the investigator to be healthy and free of any physical limitations determined by physical activity readiness questionnaire (PAR-Q+) and medical and activity history questionnaire (MHQ).
  • Participants will be required to be recreationally-active (defined according to American College of Sports Medicine standards of at least 150 minutes exercise per week and verified by information provided in the MHQ).
  • Participant is willing to abstain from dietary supplementation throughout the duration of the study as indicated in the Informed Consent.
  • Participant understands the study procedures and signs forms providing informed consent to participate in the study.

Exclusion Criteria:

  • Inability to perform physical exercise, as determined by the PAR-Q+.
  • Any "Yes" response in the PAR-Q+.
  • History of hypertension, metabolic, hepatorenal, musculoskeletal, autoimmune or neurological disease, as determined by the MHQ.
  • Regular consumption of greater than 250 mg per day of caffeine
  • Currently taking thyroid, antihyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications.
  • Taking any other nutritional supplement or performance-enhancing drug (determined from MHQ) that may interfere with the outcome variables of the study.
  • Pregnancy (determined from MHQ).

Sites / Locations

  • Kinesiology Laboratories

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

100mg Caffeine Formula

140mg Caffeine Formula

Placebo Formula

Arm Description

10kcal drink containing a total of 100 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate

10kcal drink containing a total of 140 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate

non-caloric/non-caffeinated drink

Outcomes

Primary Outcome Measures

Change in resting energy expenditure/substrate oxidation
Estimates from gas exchange analysis via indirect calorimetry
Change in energy expenditure/substrate oxidation in response to exercise
Estimates from gas exchange analysis via indirect calorimetry
Change in resting serum glycerol
Obtained from blood draw of the superficial forearm vein
Change in oxygen consumption/carbon dioxide production in response to exercise
Estimates from gas exchange analysis via indirect calorimetry
Change in resting minute ventilation
Estimates from gas exchange analysis via indirect calorimetry
Change in minute ventilation in response to exercise
Estimates from gas exchange analysis via indirect calorimetry

Secondary Outcome Measures

Change in Automated Neuropsychological Assessment Metrics (ANAM) screening
Measures from mood scale, go/no go test, Stroop test
Change in resting blood pressure response
Measured via automated blood pressure monitor
Change in resting heart rate/heart rate variability
Measured via chest-based heart rate monitor
Change in heart rate/heart rate variability in response to exercise
Measured via chest-based heart rate monitor
Change in power output
Obtained via cycle ergometer during the maximal graded exercise test

Full Information

First Posted
June 29, 2020
Last Updated
June 29, 2020
Sponsor
University of Central Florida
Collaborators
Celsius Holdings, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04455009
Brief Title
Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism
Official Title
The Acute Effects of Fitness Drink Formulas Containing 100 mg and 140 mg of Caffeine on Energy Expenditure and Fat Metabolism in Healthy Adults
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
March 8, 2018 (Actual)
Primary Completion Date
November 28, 2018 (Actual)
Study Completion Date
November 28, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Central Florida
Collaborators
Celsius Holdings, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this investigation was to examine the acute effects of consuming two different fitness drink formulas on the physiological response at rest and to exercise in healthy men and women.
Detailed Description
Thermogenic fitness drinks containing ~200mg of caffeine have been reported to accelerate the metabolism, increase energy, and consequently promote increased fat oxidation. However, determination of the efficacy of lower caffeine concentrations may provide additional options for individuals with preferences for reduced caffeine intake. Therefore, the aim of this study was to evaluate different fitness drink formulas containing a total of 100mg and 140mg of caffeine on the physiological response at rest and to exercise. This study utilized a randomized, double-blind, placebo-controlled design. All participants completed three testing visits during which they consumed the placebo, the 100mg caffeine formula, and the 140mg caffeine formula. Blood samples, blood pressure, heart rate, resting energy expenditure, substrate oxidation, and neurocognitive assessments were collected at baseline and repeated 30, 60, and 90 minutes post-ingestion. Immediately following the last cognitive assessment, a maximal graded exercise test with gas analysis was conducted on a cycle ergometer to evaluate physical performance and maximal fat oxidation during exercise as well as the physiological response prior to and following exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caffeine, Diet, Healthy, Fat Burn, Cognitive Change, Fatigue

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
100mg Caffeine Formula
Arm Type
Experimental
Arm Description
10kcal drink containing a total of 100 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate
Arm Title
140mg Caffeine Formula
Arm Type
Experimental
Arm Description
10kcal drink containing a total of 140 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate
Arm Title
Placebo Formula
Arm Type
Placebo Comparator
Arm Description
non-caloric/non-caffeinated drink
Intervention Type
Dietary Supplement
Intervention Name(s)
Fitness Drink Formula
Intervention Description
Single drink provided following baseline assessments
Primary Outcome Measure Information:
Title
Change in resting energy expenditure/substrate oxidation
Description
Estimates from gas exchange analysis via indirect calorimetry
Time Frame
Baseline, 30, 60, and 90 min post-ingestion
Title
Change in energy expenditure/substrate oxidation in response to exercise
Description
Estimates from gas exchange analysis via indirect calorimetry
Time Frame
>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Title
Change in resting serum glycerol
Description
Obtained from blood draw of the superficial forearm vein
Time Frame
Baseline, 30, 60, and 90 min post-ingestion
Title
Change in oxygen consumption/carbon dioxide production in response to exercise
Description
Estimates from gas exchange analysis via indirect calorimetry
Time Frame
>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Title
Change in resting minute ventilation
Description
Estimates from gas exchange analysis via indirect calorimetry
Time Frame
Baseline, 30, 60, and 90 min post-ingestion
Title
Change in minute ventilation in response to exercise
Description
Estimates from gas exchange analysis via indirect calorimetry
Time Frame
>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Secondary Outcome Measure Information:
Title
Change in Automated Neuropsychological Assessment Metrics (ANAM) screening
Description
Measures from mood scale, go/no go test, Stroop test
Time Frame
Baseline, 30, 60, and 90 min post-ingestion
Title
Change in resting blood pressure response
Description
Measured via automated blood pressure monitor
Time Frame
Baseline, 30, 60, and 90 min post-ingestion
Title
Change in resting heart rate/heart rate variability
Description
Measured via chest-based heart rate monitor
Time Frame
Baseline, 30, 60, and 90 min post-ingestion
Title
Change in heart rate/heart rate variability in response to exercise
Description
Measured via chest-based heart rate monitor
Time Frame
>90 min post-ingestion (pre/peri/post maximal graded exercise test)
Title
Change in power output
Description
Obtained via cycle ergometer during the maximal graded exercise test
Time Frame
>90 min post-ingestion

10. Eligibility

Sex
All
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Young adult men and women between the ages of 18 and 35 years old. Participant is deemed by the investigator to be healthy and free of any physical limitations determined by physical activity readiness questionnaire (PAR-Q+) and medical and activity history questionnaire (MHQ). Participants will be required to be recreationally-active (defined according to American College of Sports Medicine standards of at least 150 minutes exercise per week and verified by information provided in the MHQ). Participant is willing to abstain from dietary supplementation throughout the duration of the study as indicated in the Informed Consent. Participant understands the study procedures and signs forms providing informed consent to participate in the study. Exclusion Criteria: Inability to perform physical exercise, as determined by the PAR-Q+. Any "Yes" response in the PAR-Q+. History of hypertension, metabolic, hepatorenal, musculoskeletal, autoimmune or neurological disease, as determined by the MHQ. Regular consumption of greater than 250 mg per day of caffeine Currently taking thyroid, antihyperlipidemic, hypoglycemic, anti-hypertensive or androgenic medications. Taking any other nutritional supplement or performance-enhancing drug (determined from MHQ) that may interfere with the outcome variables of the study. Pregnancy (determined from MHQ).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Fukuda, PhD
Organizational Affiliation
University of Central Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kinesiology Laboratories
City
Orlando
State/Province
Florida
ZIP/Postal Code
32816
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism

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