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CaffeineNCT05559372

Energy Drink Effects on Performance, Mood, and Cardiovascular Outcomes

A study of Caffeine and Exercise Performance, run by Nathaniel Jenkins at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Energy drinks are widely promoted to increase energy, enhance mental alertness, and improve physical performance. ccording to the National Center for Complementary and Integrative Health (NCCIH) at NIH [1], next to multivitamins, energy drinks are the most popular dietary supplement consumed by American teens and… Read more about this study

Who is it for?
Ages 20 to 35 years, men onlyHealthy volunteers can take part
Conditions the study is for
Caffeine, Exercise Performance, Energy Drink
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
109 participants
Where
1 siteUnited States
Study dates
25 Oct 2021to 4 Mar 2022
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 20 to 35 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Eligibility criteria (responses needed to be considered eligible in parentheses) are:

  • Are you an assigned biological male? (Yes)
  • Are you between the ages of 20 and 35 years? (Yes)
  • Do you performed planned physical activity (i.e., planned walk/jog/run, bicycle ride, resistance exercise, sport participation, etc) on 3 or more days per week? (Yes)
  • Do you consume 21 or more servings of >=6 fl ounces of caffeinated beverages each week? (No)
  • Do you have a current illness that would impede participation in the study? (No)
  • Has your doctor ever said that you have a heart condition or high blood pressure? (No)
  • Do you feel pain in your chest at rest, during your activities of daily living, or when you do physical activity? (No)
  • Do you lose balance because of dizziness (unrelated to over-breathing) or have you lost consciousness in the last 12 months (unrelated to a head injury)? (No)
  • Do you currently have a bone, joint, or soft tissue injury that could be made worse by becoming more physically active? (No)
  • Has your doctor ever said that you should only do physical activity if it is medically supervised? (No)
  • Do you utilize nicotine or cannabis? (No)
  • Do you currently use a prescription ADD/ADHD, anti-depressant, or other central acting medication, or were you previously diagnosed with ADD/ADHD, clinical depression, or other mental health condition? (No)
  • Have you chronically (>6 months) abused illicit drugs or alcohol? (No)
  • Are you currently being treated for metabolic syndrome or have you been clinically diagnosed with or taking medication for a metabolic-disorder including pre-diabetes, type II diabetes, high blood pressure, or obesity? (No)
  • Have you been clinically diagnosed with a digestive disorder or sensitivity, or do you regularly utilize over-the-counter or dietary supplements to support gastrointestinal pain or discomfort? (No)
  • Have you ever been diagnosed with an allergy to any ingredient present in the study treatments which are commercially available energy drinks, including but not limited to caffeine, artificial sweeteners (e.g., sucralose, acesulfame potassium), niacin, maltodextrin, ginseng? (No)
  • Are you currently a competitive athlete? (No)
  • Are you willing and unwilling and able to comply with the controls or experimental conditions of the study, as described in the informed consent document? (Yes)

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Integrative Laboratory of Applied Physiology and Lifestyle Medicine

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: Effects of Energy Drink Consumption on Physiological Performance, Mood, and Cardiovascular Outcomes

Energy drinks are widely promoted to increase energy, enhance mental alertness, and improve physical performance. ccording to the National Center for Complementary and Integrative Health (NCCIH) at NIH [1], next to multivitamins, energy drinks are the most popular dietary supplement consumed by American teens and young adults. No two energy drinks are the same, with each using different ingredients. Traditionally, energy drinks contained caffeine, sugar, ginseng and B-vitamins, but newer competitors are bringing different formulations to the market that are also low-calorie/low-sugar and that contain other performance enhancing ingredients, such as beta-alanine and l-citrulline. There are also significant concerns regarding the safety of energy drink consumption. Unfortunately, there are few studies that have (1) examined the effects of energy drink consumption on performance and cardiovascular safety, nor (2) compared these effects among brands with different formulations to examine their safety and efficacy relative to each other and such studies are desperately needed, especially with the growing popularity of energy drinks [3,4].

Read the detailed description

After enrollment, subjects will participate in a familiarization visit, followed by 3 separate experimental visits. All of these visits will be separated by ~1 week, and they will occur at approximately the same time of day (±90 minutes). During the familiarization visit, subjects will complete a heath history questionnaire, and then complete brief versions of the study procedures and will be provided with an opportunity to ask questions to ensure that they are comfortable with the tests before beginning the experimental visits. In this study subjects will consume various test beverages that may enhance physiologic performance and mood. Subjects will consume one of these beverages during each of the experimental visits in randomized order. Randomization will be completed using a research randomizer (randomizer.org), and the order that the drinks are consumed at each experimental visit will be different for each participant. Subjects will be blinded to which they are consuming. The investigators performing the tests will also be blinded to the order of test beverage administration. Subjects will be asked to maintain their dietary and lifestyle practices throughout the study, abstain from alcohol and recreational drugs throughout the study, and refrain from caffeine and stimulant usage except for that contained in the test beverages. More information regarding the test beverages are provided in the sub-section immediately below. In addition, a figure providing an overview of the study design/procedures has been included as an attachment.

At each experimental visit, subjects will come to the laboratory in a fasted state and provide a urine sample to validate their hydration status. Then, they will have their body composition assessed with a medical-grade bioelectrical impedance scale, complete questionnaires assessing their mood and energy, and then have their resting blood pressure and heart rhythm (using an electrocardiogram) assessed. Following these assessments, resting femoral artery blood flow will be evaluated using an ultrasound-based assessment in the thigh. Following this test, participants will consume a test beverage (e.g., the intervention) within 5 minutes. Following beverage consumption, they will complete assessments of maximal leg muscle static strength. They will then rest for approximately 30 minutes, and will have blood pressure, heart rate and rhythym (EKG), and blood flow evaluated again. After being instrumented with specialized sensors that measure muscle activity and heart rate, and a special mask that is used to capture the pulmonary gases that they expire for analyses, participants will complete a graded exercise test on a special exercise bike. The test will get progressively harder and proceed until they cannot continue exercise, and participants will wear the special sensors and mask for the entire duration of the test. They will also provide subjective assessments of their effort throughout the test. Immediately following completion of this test, they will again complete an assessment of their maximal leg muscle strength. Following a 5-minute rest period, they will complete a sustained, submaximal leg extension task for as long as possible at about 40% of their maximal effort. A blood pressure cuff on their arm will be used to measure blood pressure at the end of exercise. They will then complete one final maximal voluntary static strength assessment. After all exercise-related testing, a 15-minute observation period will immediately ensure. During this period, leg blood flow, resting blood pressure and heart rhythm (e.g., ECG), and assessments of mood, energy, and perceived exertion will be performed. Finally, 1-week nutrition, activity, and sleep logs, mood assessments, and instructions will be provided for them to complete during the week before they leave the laboratory.

Throughout the study, the study staff will contact participants via text or email with regular reminders regarding study procedures and their scheduled experimental visits. If they do not respond to reminders, study staff will follow-up with phone calls in order to ensure they are receiving the information provided and that they are still interested in participating.

Test Beverage Information The test beverages included in this study are commercially available beverages that are advertised to increase performance. These beverages include electrolyte enhanced water, and energy drinks that contain caffeine. These drinks are all commercially available, and will also include other ingredients including sugar/glucose, ginseng, guarana extract, L-carnitine, beta-alanine, L-citrulline, betaine, and B-vitamins. The subjects and the research staff administering the tests will be blinded to the drink that subjects are consuming. The total dose of caffeine in each test beverage will not exceed 200 mg. The specific beverages used in this study will include Monster Original Green Energy which contains 160 mg of caffeine, and Nutrabolt's Cellucor Carbonated C4 Energy which contains 200 mg of caffeine.

Being tested
Acute energy drink or placebo consumption

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Acute energy drink or placebo consumptionDietary supplement

    Participants consumed either 16 oz of Nutrabolt C4 Energy Carbonated, Monster Energy Original, or Placebo in randomized order in three separate visits separated by 7±3 days.

Study groups in NCT05559372
Study groupRoleWhat they receive
Nutrabolt C4 Energy Drink CarbonatedExperimental16 oz
Receives: Dietary Supplement: Acute energy drink or placebo consumption
Monster Energy OriginalActive comparator16 oz
Receives: Dietary Supplement: Acute energy drink or placebo consumption
PlaceboPlacebo comparator16 oz carbonated placebo
Receives: Dietary Supplement: Acute energy drink or placebo consumption

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maximal Exercise Performance

    Maximal oxygen consumption during ramp cycle test

    Measured: 50-minutes after the intervention

  2. Sub-maximal Exercise Performance

    Ventilatory Threshold during ramp cycle test

    Measured: 50-minutes after the intervention

  3. Fatiguing Isometric Exercise Performance

    Total impulse (Force*time) during sub-maximal isometric fatigue test at 40% of maximal force production

    Measured: 65-minutes after the intervention

Secondary outcomes (7)
  1. Mood

    Total Mood Disturbance as Measured using the Profile of Mood States Short Form (POMS-SF)

    Measured: 80-minutes after the intervention

  2. Change in Systolic Blood Pressure

    Systolic Blood Pressure (mmHg)

    Measured: Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

  3. Change in Diastolic Blood Pressure

    Diastolic Blood Pressure (mmHg)

    Measured: Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

  4. Change in Heart Rate

    Heart Rate (bpm)

    Measured: Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

  5. Change in Rate Pressure Product

    Rate Pressure Product (bpm*mmHg)

    Measured: Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

  6. Change in QTc Interval

    QTc Interval measured by 12-lead ECG (ms)

    Measured: Pre-intervention, 40-minutes Post-intervention, 85-minutes Post-intervention

  7. Change in Leg Blood Flow

    mean femoral artery blood flow measured by high-resolution duplex ultrasonography

    Measured: Pre-intervention, 40-minutes Post-intervention, and 75-minutes Post-Intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start25 Oct 2021
  3. Primary completion4 Mar 2022
  4. Study completion4 Mar 2022

Resources

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
109 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05559372
Sponsor's protocol ID
202107364
Status last verified
May 2023
First submitted
21 Sep 2022
Last updated
1 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: De-identified data will be provided to other researchers upon reasonable request.

Publications

  • https://www.nccih.nih.gov/health/energy-drinks

  • Global energy drinks market: insights, market size, share, growth, trends analysis and forecast to 2021. AIM Market Insight. April 2015. Available at: https://www.researchandmarkets.com/research/mbbjvv/global_energy. Accessed December 20, 2017

  • De Sanctis V, Soliman N, Soliman AT, Elsedfy H, Di Maio S, El Kholy M, Fiscina B. Caffeinated energy drink consumption among adolescents and potential health consequences associated with their use: a significant public health hazard. Acta Biomed. 2017 Aug 23;88(2):222-231. doi: 10.23750/abm.v88i2.6664.

    PubMed 28845841
  • Al-Shaar L, Vercammen K, Lu C, Richardson S, Tamez M, Mattei J. Health Effects and Public Health Concerns of Energy Drink Consumption in the United States: A Mini-Review. Front Public Health. 2017 Aug 31;5:225. doi: 10.3389/fpubh.2017.00225. eCollection 2017.

    PubMed 28913331

Questions about this trial

What is this clinical trial studying?

A study of Caffeine and Exercise Performance, run by Nathaniel Jenkins 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?

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 1 Jun 2023. 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?

Maximal Exercise Performance (time frame: 50-minutes after the intervention). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05559372, which also lists 4 linked publications.

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 1 Jun 2023.

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