CaffeineNCT04455009
Acute Effects of Fitness Drink Formulas on Energy Expenditure and Fat Metabolism
A study testing Fitness Drink Formula in people with Caffeine and Diet, Healthy, run by University of Central Florida at 1 site in United States.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Caffeine, Diet, Healthy, Fat Burn
- What is being tested?
- Fitness Drink Formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Mar 2018to 28 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Caffeine, Diet, Healthy, Fat Burn, Cognitive Change, Fatigue
- Being tested
- Fitness Drink Formula
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fitness Drink FormulaDietary supplement
Single drink provided following baseline assessments
| Study group | Role | What they receive |
|---|---|---|
| 100mg Caffeine Formula | Experimental | 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 Receives: Dietary Supplement: Fitness Drink Formula |
| 140mg Caffeine Formula | Experimental | 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 Receives: Dietary Supplement: Fitness Drink Formula |
| Placebo Formula | Placebo comparator | non-caloric/non-caffeinated drink Receives: Dietary Supplement: Fitness Drink Formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in resting energy expenditure/substrate oxidation
Estimates from gas exchange analysis via indirect calorimetry
Measured: Baseline, 30, 60, and 90 min post-ingestion
Change in energy expenditure/substrate oxidation in response to exercise
Estimates from gas exchange analysis via indirect calorimetry
Measured: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
Change in resting serum glycerol
Obtained from blood draw of the superficial forearm vein
Measured: Baseline, 30, 60, and 90 min post-ingestion
Change in oxygen consumption/carbon dioxide production in response to exercise
Estimates from gas exchange analysis via indirect calorimetry
Measured: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
Change in resting minute ventilation
Estimates from gas exchange analysis via indirect calorimetry
Measured: Baseline, 30, 60, and 90 min post-ingestion
Change in minute ventilation in response to exercise
Estimates from gas exchange analysis via indirect calorimetry
Measured: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
Secondary outcomes (5)
Change in Automated Neuropsychological Assessment Metrics (ANAM) screening
Measures from mood scale, go/no go test, Stroop test
Measured: Baseline, 30, 60, and 90 min post-ingestion
Change in resting blood pressure response
Measured via automated blood pressure monitor
Measured: Baseline, 30, 60, and 90 min post-ingestion
Change in resting heart rate/heart rate variability
Measured via chest-based heart rate monitor
Measured: Baseline, 30, 60, and 90 min post-ingestion
Change in heart rate/heart rate variability in response to exercise
Measured via chest-based heart rate monitor
Measured: >90 min post-ingestion (pre/peri/post maximal graded exercise test)
Change in power output
Obtained via cycle ergometer during the maximal graded exercise test
Measured: >90 min post-ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2020
- Study start8 Mar 2018
- Primary completion28 Nov 2018
- Study completion28 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CaffeineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Central Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Celsius Holdings, Inc.
- Responsible party
- Sponsor
- Investigators
- David Fukuda, PhD, Principal investigator, University of Central Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04455009
- Sponsor's protocol ID
- BIO-17-13679
- Status last verified
- Jun 2020
- First submitted
- 29 Jun 2020
- Last updated
- 2 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04455009
- Acronym / sponsor ID
- BIO-17-13679
- Conditions
- Caffeine, Diet, Healthy, Fat Burn, Cognitive Change, Fatigue
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University of Central FloridaUniversity, hospital or other
- Collaborators
- Celsius Holdings, Inc.
- Study start
- 8 Mar 2018 (actual)
- Primary completion
- 28 Nov 2018 (actual)
- Study completion
- 28 Nov 2018 (actual)
- First posted
- 2 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 100mg Caffeine Formula | Experimental | Dietary Supplement: Fitness Drink Formula10kcal drink containing a total of 100 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate |
| 140mg Caffeine Formula | Experimental | Dietary Supplement: Fitness Drink Formula10kcal drink containing a total of 140 mg of caffeine from a proprietary blend of caffeine, guarana, ginger, and green tea extract containing epigallocatechin gallate |
| Placebo Formula | Placebo comparator | Dietary Supplement: Fitness Drink Formulanon-caloric/non-caffeinated drink |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fitness Drink FormulaSingle drink provided following baseline assessments | Dietary supplement | 100mg Caffeine Formula, 140mg Caffeine Formula, Placebo Formula |
Primary outcome
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
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
Change in resting serum glycerol
Time frame: Baseline, 30, 60, and 90 min post-ingestion
Obtained from blood draw of the superficial forearm vein
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
Change in resting minute ventilation
Time frame: Baseline, 30, 60, and 90 min post-ingestion
Estimates from gas exchange analysis via indirect calorimetry
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
5 secondary outcomes
Change in Automated Neuropsychological Assessment Metrics (ANAM) screening
Time frame: Baseline, 30, 60, and 90 min post-ingestion
Change in resting blood pressure response
Time frame: Baseline, 30, 60, and 90 min post-ingestion
Change in resting heart rate/heart rate variability
Time frame: 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)
Change in power output
Time frame: >90 min post-ingestion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Fukuda, PhD principal investigator
University of Central Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fitness Drink Formula in people with Caffeine and Diet, Healthy, run by University of Central Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in resting energy expenditure/substrate oxidation (time frame: Baseline, 30, 60, and 90 min post-ingestion). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2020.