- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04455009
Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism
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 Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Florida
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Orlando, Florida, United States, 32816
- Kinesiology Laboratories
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 100mg Caffeine Formula
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
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Single drink provided following baseline assessments
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Experimental: 140mg Caffeine Formula
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
|
Single drink provided following baseline assessments
|
Placebo Comparator: Placebo Formula
non-caloric/non-caffeinated drink
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Single drink provided following baseline assessments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in resting energy expenditure/substrate oxidation
Time Frame: Baseline, 30, 60, and 90 min post-ingestion
|
Estimates from gas exchange analysis via indirect calorimetry
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Baseline, 30, 60, and 90 min post-ingestion
|
Change in energy expenditure/substrate oxidation in response to exercise
Time Frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
|
Estimates from gas exchange analysis via indirect calorimetry
|
>90 min post-ingestion (pre/peri/post maximal graded exercise test)
|
Change in resting serum glycerol
Time Frame: Baseline, 30, 60, and 90 min post-ingestion
|
Obtained from blood draw of the superficial forearm vein
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Baseline, 30, 60, and 90 min post-ingestion
|
Change in oxygen consumption/carbon dioxide production in response to exercise
Time Frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
|
Estimates from gas exchange analysis via indirect calorimetry
|
>90 min post-ingestion (pre/peri/post maximal graded exercise test)
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Change in resting minute ventilation
Time Frame: Baseline, 30, 60, and 90 min post-ingestion
|
Estimates from gas exchange analysis via indirect calorimetry
|
Baseline, 30, 60, and 90 min post-ingestion
|
Change in minute ventilation in response to exercise
Time Frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
|
Estimates from gas exchange analysis via indirect calorimetry
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>90 min post-ingestion (pre/peri/post maximal graded exercise test)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Automated Neuropsychological Assessment Metrics (ANAM) screening
Time Frame: Baseline, 30, 60, and 90 min post-ingestion
|
Measures from mood scale, go/no go test, Stroop test
|
Baseline, 30, 60, and 90 min post-ingestion
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Change in resting blood pressure response
Time Frame: Baseline, 30, 60, and 90 min post-ingestion
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Measured via automated blood pressure monitor
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Baseline, 30, 60, and 90 min post-ingestion
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Change in resting heart rate/heart rate variability
Time Frame: Baseline, 30, 60, and 90 min post-ingestion
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Measured via chest-based heart rate monitor
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Baseline, 30, 60, and 90 min post-ingestion
|
Change in heart rate/heart rate variability in response to exercise
Time Frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
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Measured via chest-based heart rate monitor
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>90 min post-ingestion (pre/peri/post maximal graded exercise test)
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Change in power output
Time Frame: >90 min post-ingestion
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Obtained via cycle ergometer during the maximal graded exercise test
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>90 min post-ingestion
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: David Fukuda, PhD, University of Central Florida
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIO-17-13679
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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