Substrate OxidationEDXNCT06308731
Exercise-Induced Rates of Fat Oxidation with and Without Ingestion of a Caffeine-Based Energy Drink
A study testing Caffeine-Based Energy Drink in people with Substrate Oxidation and Energy Expenditure, run by Lindenwood University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Substrate Oxidation, Energy Expenditure, Reaction Time
- What is being tested?
- Caffeine-Based Energy Drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jan 2024to 16 Sep 2024
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants between 18 - 50 years of age
- Signed informed consent
- Healthy defined as currently not being treated for an active cardiac, pulmonary, metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal, psychiatric, or reproductive disease or disorder. With the research team and principal investigator's discretion, some ongoing treatments will be permitted if a determination is made that the treatment will not increase the risk of study participation and the treatment will not confound with desired study outcomes
- Physically active which is defined as performing aerobic or resistance-based physical exercise between 2 and 5 times per week
- Moderate caffeine users (~300 mg/day)
- Body mass index values will range from >24.0 to < 31.9 kg/m2. The average body mass index for the entire study cohort will be less than 31.99 kg/m2. As such, an ongoing calculation of the recruited cohort's mean body mass index will be maintained and people will only be randomized into the study if the average cohort body mass index value does not exceed 31.99 kg/m2
- Willing and able to agree to the requirements and restrictions of this study, be willing to give voluntary consent, and carry out all study-related procedures
Who cannot join
- Body mass index > 31.9 kg/m2
- Positive medical history and/or is currently being treated for some form of heart or cardiovascular, neurological impairment, disease or condition, immune disorder or disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver disease, or other diagnosed hepatic impairment
- Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
- Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
- History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
- Participant has an abnormality or obstruction of the gastrointestinal tract precluding swallowing (e.g., dysphagia) and digestion (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease, chronic pancreatitis, steatorrhea)
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- Currently prescribed statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha-blockers, Vasodilators, etc.) or any other medication at the discretion of the principal investigator
- Current smoker (>10 cigarettes per day)
- Participants who are lactating, pregnant, or planning to become pregnant
- History of alcohol or substance abuse in the 6 months prior to screening
- Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol
- Any condition or abnormality that, in the opinion of the investigator, would compromise the safety of the participant or the quality of the study data
- Extensive travel (>1 month) that will disrupt the original outline of the study protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Exercise and Performance Nutrition Laboratory
Saint Charles, Missouri, 63301
About this study
Official title: A Crossover Study to Examine Exercise-Induced Rates of Fat Oxidation with and Without Ingestion of a Caffeine-Based Energy Drink
The purpose of this study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink.
Read the detailed description
This study aims to investigate the impact of a caffeinated energy drink on cognitive function and exercise performance in healthy adults. The research will employ a randomized, double-blind, placebo-controlled, crossover design involving 15 participants. Initial screening includes health assessments and completion of a health history questionnaire, as well as a VO2peak assessment. Participants will replicate their diet before every study visit. Subsequent visits involve baseline assessments, ingestion of either a placebo or a caffeinated energy drink, followed by cognitive tests and a cycling exercise bout at moderate intensity, followed by a exercise performance cycling time trial. Measurements, including heart rate, perceived exertion, blood samples, and expired gases, will be collected during and after exercise. The study will have two identical testing visits, separated by at least a week, with participants consuming different beverages to assess their impact on cognitive function and exercise performance.
- Being tested
- Caffeine-Based Energy Drink, Placebo
- Keywords
- energy drink, exercise performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine-Based Energy DrinkDietary supplement
Energy drink with 200 mg caffeine
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Caffeine-Based Energy Drink | Experimental | 12 oz Caffeine-based energy drink providing 200 mg caffeine Receives: Dietary Supplement: Caffeine-Based Energy Drink |
| Placebo | Placebo comparator | 12 oz placebo void of all active ingredients Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise.
Fat oxidation rate (grams/min) during exercise
Measured: 150 minutes during exercise
Secondary outcomes (9)
Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise.
Energy expenditure (kcals/min)
Measured: 150 minutes during exercise
Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise
Carbohydrate oxidation rates (grams/min)
Measured: 150 minutes during exercise
Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration
Plasma glycerol concentration
Measured: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration
Plasma free fatty acid concentration
Measured: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion
Rating of Perceived Exertion (RPE) scale
Measured: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on exercise performance
Cycling time trial
Measured: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on reaction time
Simple/ choice reaction time
Measured: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on trail making test performance
Trail making test
Measured: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on Cognition
Serial 7 Cognitive processing test
Measured: 150 minutes after intervention ingestion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study start19 Jan 2024
- Primary completion16 Sep 2024
- Study completion16 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Substrate OxidationStudies 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
- Model description
- Double-blind, placebo controlled, crossover design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308731
- Sponsor's protocol ID
- 23-26
- Acronym
- EDX
- Status last verified
- Oct 2024
- First submitted
- 8 Dec 2023
- Last updated
- 17 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Investigators do not plan to make individual participant data available to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Crossover Study to Examine Exercise-Induced Rates of Fat Oxidation with and Without Ingestion of a Caffeine-Based Energy Drink
- ClinicalTrials.gov ID
- NCT06308731
- Acronym / sponsor ID
- EDX / 23-26
- Keywords
- energy drink, exercise performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 19 Jan 2024 (actual)
- Primary completion
- 16 Sep 2024 (actual)
- Study completion
- 16 Sep 2024 (actual)
- First posted
- 13 Mar 2024 (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 study is to evaluate acute changes in rates of fat oxidation during exercise with and without the ingestion of a caffeine-based energy drink.
Detailed description
This study aims to investigate the impact of a caffeinated energy drink on cognitive function and exercise performance in healthy adults. The research will employ a randomized, double-blind, placebo-controlled, crossover design involving 15 participants. Initial screening includes health assessments and completion of a health history questionnaire, as well as a VO2peak assessment. Participants will replicate their diet before every study visit. Subsequent visits involve baseline assessments, ingestion of either a placebo or a caffeinated energy drink, followed by cognitive tests and a cycling exercise bout at moderate intensity, followed by a exercise performance cycling time trial. Measurements, including heart rate, perceived exertion, blood samples, and expired gases, will be collected during and after exercise. The study will have two identical testing visits, separated by at least a week, with participants consuming different beverages to assess their impact on cognitive function and exercise performance.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Double-blind, placebo controlled, crossover design
| Arm | Type | Receives |
|---|---|---|
| Caffeine-Based Energy Drink | Experimental | Dietary Supplement: Caffeine-Based Energy Drink12 oz Caffeine-based energy drink providing 200 mg caffeine |
| Placebo | Placebo comparator | Other: Placebo12 oz placebo void of all active ingredients |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male or female participants between 18 - 50 years of age
- Signed informed consent
- Healthy defined as currently not being treated for an active cardiac, pulmonary, metabolic, immunological, neurological, respiratory, orthopedic, musculoskeletal, psychiatric, or reproductive disease or disorder. With the research team and principal investigator's discretion, some ongoing treatments will be permitted if a determination is made that the treatment will not increase the risk of study participation and the treatment will not confound with desired study outcomes
- Physically active which is defined as performing aerobic or resistance-based physical exercise between 2 and 5 times per week
- Moderate caffeine users (~300 mg/day)
Key exclusion criteria (13 listed)
- Body mass index > 31.9 kg/m2
- Positive medical history and/or is currently being treated for some form of heart or cardiovascular, neurological impairment, disease or condition, immune disorder or disease, thyroid disease, kidney disease, renal failure, regular dialysis, liver disease, or other diagnosed hepatic impairment
- Diagnosed with having Type I or Type II diabetes (determined as fasting blood glucose > 126 mg/dL)
- Diagnosed with major affective disorder or other psychiatric disorder that required hospitalization in the prior year
- History of cancer (except localized skin cancer without metastases or in situ cervical cancer within 5 years prior to screening visit).
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 |
|---|---|---|
| Caffeine-Based Energy DrinkEnergy drink with 200 mg caffeine | Dietary supplement | Caffeine-Based Energy Drink |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise.
Time frame: 150 minutes during exercise
Fat oxidation rate (grams/min) during exercise
9 secondary outcomes
Impact of a caffeine-based energy drink ingestion on energy expenditure rates during exercise.
Time frame: 150 minutes during exercise
Impact of a caffeine-based energy drink ingestion on carbohydrate oxidation during exercise
Time frame: 150 minutes during exercise
Impact of a caffeine-based energy drink ingestion on plasma glycerol concentration
Time frame: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on plasma free fatty acid concentration
Time frame: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on ratings of perceived exertion
Time frame: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on exercise performance
Time frame: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on reaction time
Time frame: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on trail making test performance
Time frame: 150 minutes after intervention ingestion
Impact of a caffeine-based energy drink ingestion on Cognition
Time frame: 150 minutes after intervention 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 17 Oct 2024.
- Individual participant dataSharing planned: No. Investigators do not plan to make individual participant data available to other researchers
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine-Based Energy Drink in people with Substrate Oxidation and Energy Expenditure, run by Lindenwood University 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 7 inclusion and 13 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 17 Oct 2024. 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?
Impact of a caffeine-based energy drink ingestion on fat oxidation rates during exercise. (time frame: 150 minutes during exercise). 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 17 Oct 2024.