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Cognitive PerformanceNCT06890962

Citicoline Dose on Energy Drink Efficacy

A study testing Energy drink consumption in people with Cognitive Performance and Gaming 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

The purpose of this study is to determine how the doses of cognitive-enhancing ingredients such as citicoline and caffeine effect the efficacy of acute energy drink consumption for improving cognitive performance (primary outcome), gaming performance, mood, energy expenditure, and fat oxidation. Read more about this study

Who is it for?
Ages 18 to 50 yearsHealthy volunteers can take part
What is being tested?
Energy drink consumption
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
34 participants
Where
1 siteUnited States
Study dates
9 Jun 2023to 1 Dec 2023
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

  • Fitness: Healthy, recreationally trained (>2 d/wk physical activity)
  • BMI: (<30kg/m2) or BF <25% (M) and <32% (F)

Who cannot join

  • <1 hr/wk playing video games
  • >=21 servings of >=170.5 mL (or >=6 fl oz) caffeine beverages per week [(PMID: 33525438)]
  • Injury or illness
  • Habitual nicotine or cannabis use
  • Use of prescription ADD/ADHD, anti-depressant, or other central acting medication, or previously diagnosed ADD/ADHD, clinical depression, or other mental health condition
  • Use of prescription, OTC, or dietary supplements to support sleep, or having been diagnosed with a clinical sleep condition
Show all 11Show fewer
  • Current or prior chronic (>6 mo) illicit drug or alcohol abuse
  • Clinically diagnosed with, or taking medication for a cardiometabolic disease or disorder (e.g., Pre-diabetes, Type II diabetes, high blood pressure, chronic kidney disease, cardiovascular disease, obesity, etc.)
  • Clinically diagnosed digestive disorder or sensitivity, or regular use of OTC or dietary supplements to support gastrointestinal pain or discomfort
  • Competitive athlete
  • Failure to comply with the controls and conditions of this study

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Iowa

    Iowa City, Iowa, 52242

Other trials in United States

About this study

Official title: The Effect of Citicoline and Caffeine Dose in a Commercial Energy Drink on Cognitive Performance, Energy Expenditure and Fat Oxidation in Young Adults

The purpose of this study is to determine how the doses of cognitive-enhancing ingredients such as citicoline and caffeine effect the efficacy of acute energy drink consumption for improving cognitive performance (primary outcome), gaming performance, mood, energy expenditure, and fat oxidation. This study will utilize an In vivo acute response, randomized, double-blind, placebo controlled, cross-over trial study design. Participants will complete consent, complete screening, and then undergo familiarization and complete four experimental study visits. In brief, participants will consume a commercially available energy drink specifically formulated to improve cognitive performance with the standard dose of Cognizin, a reduced dose of Cognizin, a reduced dose of caffeine and Cognizin, or a placebo (water, which will be carbonated, matched for flavor, mouthfeel, etc.), then complete a battery of computer-based cognitive performance test, tasks in a video game (Tetris) to assess video game performance, have their resting metabolism analyzed, and then assessments of mood. Following a 1-week washout period, participants will return and consume one of the four remaining beverages and complete the same tasks. They will participate in four experimental visits, each time consuming a different beverage until they have consumed all beverages and completed all necessary tasks.

Question(s) and Hypotheses (stated in null) Q: Does acute consumption of a new formulations (reduced active ingredients [citicoline and caffeine]) of a commercially available energy drink elicit similar improvements in cognitive performance, mood, energy expenditure and fat oxidation in young adults than the standard, currently marketed dose to formulation?

Read more

H1: Acute consumption of the commercially available energy drink with standard dosing will improve cognitive performance compared to the reduced dose beverages and the placebo.

H2: Acute consumption of the commercially available energy drink with standard dosing will improve gaming (Tetris) performance compared to the reduced dose beverages and the placebo.

H3: Acute consumption of the commercially available energy drink with standard dosing will improve mood compared to the reduced dose beverages and the placebo.

H4: Acute consumption of a commercially available energy drink with standard dosing will increase energy expenditure and fat oxidation compared to the reduced dose beverages and the placebo.

Being tested
Energy drink consumption

What participants receive

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

  • Energy drink consumptionDietary supplement

    Participants will consume an energy drink (or placebo) and then undergo experimental testing after a 40 minute rest period following drink consumption.

Study groups in NCT06890962
Study groupRoleWhat they receive
Standard Energy DrinkActive comparatorC4 Smart Energy, 1 can, administered acutely
Receives: Dietary Supplement: Energy drink consumption
Reduced Citicoline Energy DrinkExperimentalC4 Smart Energy Reduced Citicoline, 1 can, administered acutely
Receives: Dietary Supplement: Energy drink consumption
Reduced Citicoline and Caffeine Energy DrinkExperimentalC4 Smart Energy Reduced Citicoline and Caffeine, 1 can, administered acutely
Receives: Dietary Supplement: Energy drink consumption
PlaceboPlacebo comparatorPlacebo Drink devoid of active ingredients, 1 can, administered acutely
Receives: Dietary Supplement: Energy drink consumption

What is being measured

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

  1. Executive Function

    How well a subject recognizes rules, categories, and manages or navigates rapid decision making. Assessed as Shifting Attention Task (SAT) Correct Responses - SAT Errors.

    Measured: 60 minutes post-drink consumption

  2. Resting Fat Oxidation

    Resting fat oxidation (g/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.

    Measured: 50 minutes post-drink consumption

  3. Video Game Performance

    Performance in the two-dimensional visuospatial game Tetris. Participants will be given four minutes of play time on Marathon mode and instructed to maximize the score (points) displayed on the screen. The total score at the end of play time will be recorded.

    Measured: 90 minutes post-drink consumption

Secondary outcomes (10)
  1. Sustained Attention

    Measure of how well a subject can direct and focus cognitive activity on specific stimuli. Assessed using the 4-part Continuous Performance Test, which requires the subject to respond to the target stimulus "B" but not to any other letter. Stimuli are presented at random and the subject responds by pressing the SPACE BAR. Sustained Attention is then quantified as:

    (Part 2 Correct Responses + Part 3 Correct Responses + Part 4 Correct Responses) - (Part 2 Incorrect Responses + Part 3 Incorrect Responses + Part 4 Incorrect Responses)

    Measured: 60 minutes post-drink consumption

  2. Psychomotor Speed

    Measure of how well a subject perceives, attends, responds to visual-perceptual information, and performs motor speed and fine motor coordination. To assess psychomotor speed, participants will complete two tests:

    1. The finger tapping test (FTT), which requires subjects respond by pressing the SPACE BAR with their right index finger as many times as they can in 10 seconds. They do this once for practice, and then there are three test trials. The test is repeated with the left hand; and
    2. The symbol digit coding test (SDC), which consists of serial presentations of screens, each of which contains a bank of eight symbols above eight empty boxes. The participant types in the number on the NUMBER ROW that corresponds to the symbol that is highlighted.

    Psychomotor Speed is then quantified as a singular outcome using data aggregated from these two tests as:

    FTT Right Taps Average + FTT Left Taps Average + SDC Correct Responses

    Measured: 60 minutes post-drink consumption

  3. Working Memory

    Measure of how well a subject can perceive and attend to symbols using short-term memory processes. Working memory is assessed via completion of the 4-part Continuous Performance Test, which requires the subject to respond to the target stimulus "B" but not to any other letter. Stimuli are presented at random and the subject responds by pressing the SPACE BAR.

    Working memory is assessed as: Part 4 Correct Responses - Part 4 Incorrect Responses

    Measured: 60 minutes post-drink consumption

  4. Cognitive Flexibility

    Measure of how well subject is able to adapt to rapidly changing and increasingly complex set of directions and/or to manipulate the information. Two tests will be used to assess:

    1. the Shifting Attention Test (SAT), where a square or circle appears at the top of the screen and a square and a circle on the bottom. The figures are either red or blue. The participant is asked to match a bottom figure to the top figure by shape or color with the rules changing at random; and
    2. the Stroop Test, which requires participants to identify the words red, yellow, blue, and green appearing on the screen (part 1), when the color of the word matches what the word says (part 2), or when the color of the word does not match what the word says (part 3).

    Cognitive Flexibility is then quantified as a singular outcome using data aggregated from these two tests as: SAT Correct Responses - SAT Errors - Stroop Commission Errors

    Measured: 60 minutes post-drink consumption

  5. Resting Metabolic Rate

    Resting metabolic rate (kcal/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.

    Measured: 50 minutes post-drink consumption

  6. Resting Respiratory Exchange Ratio

    Resting respiratory exchange ratio will be quantified from resting, fasted analyses of pulmonary gas exchange.

    Measured: 50 minutes post-drink consumption

  7. Total Mood Disturbance

    Total mood disturbance will be quantified using the Profile of Mood State Short Form Questionnaire.

    Measured: 105-minutes post-drink consumption

  8. Vigor-Activity

    Vigor will be quantified using the Profile of Mood State Short Form

    Measured: 105-minutes post-drink consumption

  9. Heart rate

    Heart rate will be quantified from a standard 3-lead ECG

    Measured: pre-drink consumption, 40-minutes post-drink consumption, 110 minutes post-drink consumption

  10. Blood Pressure

    Systolic, diastolic, and pulse pressures (mmHg) will be quantified from brachial

    Measured: pre-drink consumption, 40 minutes post-drink consumption, 110 minutes post-drink consumption

Timeline

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

  1. First posted24 Mar 2025
  2. Study start9 Jun 2023
  3. Primary completion1 Dec 2023
  4. Study completion1 Dec 2023

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
Model description
4 condition, randomized cross-over with 3-7 day washout between conditions
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06890962
Sponsor's protocol ID
202302574
Status last verified
Mar 2025
First submitted
3 Jun 2024
Last updated
24 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Energy drink consumption in people with Cognitive Performance and Gaming 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?

The sponsor lists 2 inclusion and 11 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 24 Mar 2025. 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?

Executive Function (time frame: 60 minutes post-drink consumption). 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?
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 24 Mar 2025.

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