Energy ExpenditureASHNCT05998096
A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators
A study testing Caffeine-Based Energy Drink in people with Energy Expenditure and Cognition, run by Lindenwood University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the changes in energy expenditure, fat oxidation, reaction time, and perceptual indicators of energy and focus after acute 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
- Energy Expenditure, Cognition, 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
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2023to 23 Apr 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, is 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 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 a 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 6. cervical cancer within 5 years prior to screening visit).
- 7. 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) 7. Currently prescribed statin drugs (i.e., Lipitor, Livalo, Crestor, Zocor, etc.) or any hypertension medications (i.e., Beta-blockers, ACE Inhibitors, Alpha-blockers, 8. Vasodilators, etc.) or any other medication at the discretion of the principal investigator 9. Current smoker (>10 cigarettes per day) 10. Participants who are lactating, pregnant, or planning to become pregnant History of alcohol or substance abuse in the 6 months prior to screening 11. Receipt or use of an investigational product in another research study within 60 days of beginning the study protocol 12. 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 13. 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
The purpose of this study is to evaluate the changes in energy expenditure, fat oxidation, reaction time, and perceptual indicators of energy and focus after acute ingestion of a caffeine-based energy drink. Approximately 60 healthy adults aged 18-50 will be recruited for a randomized, double-blind, placebo-controlled study. They will undergo baseline measurements for energy expenditure, fat and carbohydrate oxidation, reaction time, cognition, and perceptual indicators of energy, focus, and concentration. After 28 days, these measurements will be taken again, comparing the effects of a caffeine-based energy drink versus a placebo.
Read the detailed description
The study will be conducted using a randomized, double-blind, placebo-controlled, parallel study design. Approximately 60 healthy men and women between the ages of 18 - 55 years of age will be recruited to participate in this study. Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a health history questionnaire to determine study eligibility. All participants will report to the laboratory for all study visits between 0600 - 1000 hours. Prior to each study visit, participants will be asked to abstain from exercise, tobacco, nicotine, and alcohol for 12 hours and observe an overnight (8 - 10 hours) fast including caffeine. Study visit 1 will be a screening visit where participants will first sign an IRB-approved informed consent document. To determine eligibility, participants will then complete a health and medical history form and have their height and weight assessed along with their resting heart rate and blood pressure. If determined eligible, study participants will then have their body composition assessed and then be asked to record their past 24-hour intake of food and fluid. This form will be copied and all participants will be instructed to replicate this diet prior to each visit.
Study visits 2 and 3 will be identical and separated by approximately 28 days whereby each study participant will have ingested a single dose of their assigned beverage each day between visits 2 and 3. Prior to these visits, participants will not be allowed to exercise within 24 hours of each subsequent study visit and may only partake in a light workout two days prior to their study visit. Participants will be instructed to follow an overnight fast whereby no food or fluid with calories will be consumed for the 8 to 10-hour period prior to each study visit. Water intake will be encouraged during this time for appropriate hydration status. Upon arrival for study visits 2 and 3, body mass will be assessed before having their body temperature, resting heart rate, and blood pressure assessed. From there, participants will be instructed to complete simple and choice reaction time and cognition assessments using a DynaVision board. After cognition assessments are completed, visual analog scales will be completed to assess perceived levels of energy, focus, and concentration. Finally, participants will then complete a resting metabolic assessment to evaluate rates of calorie burning (energy expenditure), rate of fat oxidation, and amount of fat oxidized. After completion of all assessments, participants will ingest their assigned dose of beverage. Each participant will be given 15 minutes to ingest their assigned beverage. As soon as the entire beverage is consumed, the study protocol timer will be activated and all subsequent assessments will occur as outlined. During visit 2 (dose 1) and visit 3 (dose 28), participants will have energy expenditure and fat oxidation assessments completed 0, 30, 60, 90, and 120 minutes after ingestion while cognition, hemodynamics, and VAS will be evaluated 0, 60, and 120 minutes.
Participants will be assigned to each group in a randomized, double-blind, placebo-controlled fashion with parallel groups that are matched according to BMI and gender. This will ensure each study condition has similar numbers of males and females that are of similar body mass index levels. After completion of study visit 2, participants will be provided with a 14-day supply of their assigned beverage. After 14 days, participants must return to the laboratory to pick up their remaining assigned beverage and communicate with research staff about compliance, adverse events, etc. After 28 days of supplementation, participants will return to the laboratory for study visit 3, which will complete their participation in the study.
- Conditions
- Energy Expenditure, Cognition, Reaction Time
- Being tested
- Caffeine-Based Energy Drink, Placebo
- Keywords
- energy expenditure, cognition, reaction time
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine-Based Energy DrinkDietary supplement
Caffeine-based energy drink containing 200 mg caffeine
PlaceboDietary supplement
Placebo void of all active ingredients
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo (void of all actives) Receives: Dietary Supplement: Placebo |
| Caffeine-Based Energy Drink | Active comparator | Caffeine-based energy drink containing 200 mg caffeine Receives: Dietary Supplement: Caffeine-Based Energy Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy expenditure (kcals/min)
Impact of a caffeine-based energy drink ingestion on energy expenditure (calorie burning)
Measured: 28 days
Secondary outcomes (8)
Rates of fat oxidation
Impact of a caffeine-based energy drink ingestion on fat oxidation
Measured: 28 days
Energy Visual Analog Scale
Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)
Measured: 28 days
Focus Visual Analog Scale
Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)
Measured: 28 days
Concentration Visual Analog Scale
Impact of a caffeine-based energy drink ingestion on perceptual indicators of affect through visual analog scales (VAS)
Measured: 28 days
Simple reaction time
Impact of a caffeine-based energy drink ingestion on reaction time
Measured: 28 days
Choice reaction time
Impact of a caffeine-based energy drink ingestion on reaction time
Measured: 28 days
Trail Making Test
Impact of a caffeine-based energy drink ingestion on cognition
Measured: 28 days
Serial Sevens
Impact of a caffeine-based energy drink ingestion on cognition
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2023
- Study start1 Sep 2023
- Primary completion23 Apr 2024
- Study completion23 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Energy ExpenditureStudies 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
- Parallel groups
- Model description
- Randomized, double-blind, placebo-controlled, parallel study design
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lindenwood University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chad M Kerksick, PhD, Principal investigator, Lindenwood University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05998096
- Sponsor's protocol ID
- IRB-23-95
- Acronym
- ASH
- Status last verified
- Jun 2024
- First submitted
- 10 Aug 2023
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Study to Examine the Ability of a Caffeine-Based Energy Drink to Impact Energy Expenditure, Fat Oxidation, Reaction Time, and Other Perceptual Indicators
- ClinicalTrials.gov ID
- NCT05998096
- Acronym / sponsor ID
- ASH / IRB-23-95
- Conditions
- Energy Expenditure, Cognition, Reaction Time
- Keywords
- energy expenditure, cognition, reaction time
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Lindenwood UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 23 Apr 2024 (actual)
- Study completion
- 23 Apr 2024 (actual)
- First posted
- 18 Aug 2023 (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 the changes in energy expenditure, fat oxidation, reaction time, and perceptual indicators of energy and focus after acute ingestion of a caffeine-based energy drink. Approximately 60 healthy adults aged 18-50 will be recruited for a randomized, double-blind, placebo-controlled study. They will undergo baseline measurements for energy expenditure, fat and carbohydrate oxidation, reaction time, cognition, and perceptual indicators of energy, focus, and concentration. After 28 days, these measurements will be taken again, comparing the effects of a caffeine-based energy drink versus a placebo.
Detailed description
The study will be conducted using a randomized, double-blind, placebo-controlled, parallel study design. Approximately 60 healthy men and women between the ages of 18 - 55 years of age will be recruited to participate in this study. Prior to beginning the study, all participants will sign an IRB-approved informed consent document and complete a health history questionnaire to determine study eligibility. All participants will report to the laboratory for all study visits between 0600 - 1000 hours. Prior to each study visit, participants will be asked to abstain from exercise, tobacco, nicotine, and alcohol for 12 hours and observe an overnight (8 - 10 hours) fast including caffeine. Study visit 1 will be a screening visit where participants will first sign an IRB-approved informed consent document. To determine eligibility, participants will then complete a health and medical history form and have their height and weight assessed along with their resting heart rate and blood pressure. If determined eligible, study participants will then have their body composition assessed and then be asked to record their past 24-hour intake of food and fluid. This form will be copied and all participants will be instructed to replicate this diet prior to each visit.
Study visits 2 and 3 will be identical and separated by approximately 28 days whereby each study participant will have ingested a single dose of their assigned beverage each day between visits 2 and 3. Prior to these visits, participants will not be allowed to exercise within 24 hours of each subsequent study visit and may only partake in a light workout two days prior to their study visit. Participants will be instructed to follow an overnight fast whereby no food or fluid with calories will be consumed for the 8 to 10-hour period prior to each study visit. Water intake will be encouraged during this time for appropriate hydration status. Upon arrival for study visits 2 and 3, body mass will be assessed before having their body temperature, resting heart rate, and blood pressure assessed. From there, participants will be instructed to complete simple and choice reaction time and cognition assessments using a DynaVision board. After cognition assessments are completed, visual analog scales will be completed to assess perceived levels of energy, focus, and concentration. Finally, participants will then complete a resting metabolic assessment to evaluate rates of calorie burning (energy expenditure), rate of fat oxidation, and amount of fat oxidized. After completion of all assessments, participants will ingest their assigned dose of beverage. Each participant will be given 15 minutes to ingest their assigned beverage. As soon as the entire beverage is consumed, the study protocol timer will be activated and all subsequent assessments will occur as outlined. During visit 2 (dose 1) and visit 3 (dose 28), participants will have energy expenditure and fat oxidation assessments completed 0, 30, 60, 90, and 120 minutes after ingestion while cognition, hemodynamics, and VAS will be evaluated 0, 60, and 120 minutes.
Participants will be assigned to each group in a randomized, double-blind, placebo-controlled fashion with parallel groups that are matched according to BMI and gender. This will ensure each study condition has similar numbers of males and females that are of similar body mass index levels. After completion of study visit 2, participants will be provided with a 14-day supply of their assigned beverage. After 14 days, participants must return to the laboratory to pick up their remaining assigned beverage and communicate with research staff about compliance, adverse events, etc. After 28 days of supplementation, participants will return to the laboratory for study visit 3, which will complete their participation in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, double-blind, placebo-controlled, parallel study design
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo (void of all actives) |
| Caffeine-Based Energy Drink | Active comparator | Dietary Supplement: Caffeine-Based Energy DrinkCaffeine-based energy drink containing 200 mg caffeine |
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, is 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 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 (6 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 a 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 6. 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 DrinkCaffeine-based energy drink containing 200 mg caffeine | Dietary supplement | Caffeine-Based Energy Drink |
| PlaceboPlacebo void of all active ingredients | Dietary supplement | Placebo |
Primary outcome
Energy expenditure (kcals/min)
Time frame: 28 days
Impact of a caffeine-based energy drink ingestion on energy expenditure (calorie burning)
8 secondary outcomes
Rates of fat oxidation
Time frame: 28 days
Energy Visual Analog Scale
Time frame: 28 days
Focus Visual Analog Scale
Time frame: 28 days
Concentration Visual Analog Scale
Time frame: 28 days
Simple reaction time
Time frame: 28 days
Choice reaction time
Time frame: 28 days
Trail Making Test
Time frame: 28 days
Serial Sevens
Time frame: 28 days
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 11 Jun 2024.
- 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.
Chad M Kerksick, PhD principal investigator
Lindenwood University
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 Energy Expenditure and Cognition, 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 6 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 11 Jun 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?
Energy expenditure (kcals/min) (time frame: 28 days). 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 11 Jun 2024.