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CompletedNCT04455009Updated Jul 2, 2020

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

An interventional study of Fitness Drink Formula in Caffeine, Diet, Healthy and Fat Burn, sponsored by University of Central Florida. Completed at 1 site in United States. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-07-02.

Sponsored by University of Central Florida · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 2 years 3 months after the study started (first participant enrolled Mar 2018, registered Jun 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Caffeine
  • Diet, Healthy
  • Fat Burn
  • Cognitive Change
  • Fatigue

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03

In context

Fatigue

1,860 studies on the registry are indexed under Fatigue; 376 are open to participants now.

This study's enrollment of 56 is close to the median of 54 across 1,440 interventional studies indexed under Fatigue.

Browse Fatigue studies →

Lead sponsor

University of Central Florida is the lead sponsor of 99 studies on the registry; 40 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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).
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
56 participants (actual)

Study arms

  • 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

    Dietary Supplement: Fitness Drink Formula

  • 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

    Dietary Supplement: Fitness Drink Formula

  • Placebo comparator
    Placebo Formula

    non-caloric/non-caffeinated drink

    Dietary Supplement: Fitness Drink Formula

Interventions

  • Dietary supplementFitness Drink Formula

    Single drink provided following baseline assessments

06

What researchers measure

Primary outcomes

  1. Change in resting energy expenditure/substrate oxidation

    Estimates from gas exchange analysis via indirect calorimetry

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

  2. Change in energy expenditure/substrate oxidation in response to exercise

    Estimates from gas exchange analysis via indirect calorimetry

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

  3. Change in resting serum glycerol

    Obtained from blood draw of the superficial forearm vein

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

  4. Change in oxygen consumption/carbon dioxide production in response to exercise

    Estimates from gas exchange analysis via indirect calorimetry

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

  5. Change in resting minute ventilation

    Estimates from gas exchange analysis via indirect calorimetry

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

  6. Change in minute ventilation in response to exercise

    Estimates from gas exchange analysis via indirect calorimetry

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

Secondary outcomes

  1. Change in Automated Neuropsychological Assessment Metrics (ANAM) screening

    Measures from mood scale, go/no go test, Stroop test

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

  2. Change in resting blood pressure response

    Measured via automated blood pressure monitor

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

  3. Change in resting heart rate/heart rate variability

    Measured via chest-based heart rate monitor

    Time frame: Baseline, 30, 60, and 90 min post-ingestion

  4. Change in heart rate/heart rate variability in response to exercise

    Measured via chest-based heart rate monitor

    Time frame: >90 min post-ingestion (pre/peri/post maximal graded exercise test)

  5. Change in power output

    Obtained via cycle ergometer during the maximal graded exercise test

    Time frame: >90 min post-ingestion

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Study locations

1 site
  • Kinesiology Laboratories
    Orlando, Florida 32816, United States
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04455009
Lead sponsor
University of Central Florida
Collaborators
Celsius Holdings, Inc.
Responsible party
Sponsor
First posted
Jul 2, 2020
Start date
Mar 8, 2018
Primary completion
Nov 28, 2018
Completion
Nov 28, 2018
Last update
Jul 2, 2020

Study contacts

David Fukuda, PhD
principal investigator · University of Central Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.

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