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.
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
- Conditions the study is for
- Cognitive Performance, Gaming Performance, Blood Pressure
- 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.
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.
- Conditions
- Cognitive Performance, Gaming Performance, Blood Pressure, Heart Rate, Mood
- 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 group | Role | What they receive |
|---|---|---|
| Standard Energy Drink | Active comparator | C4 Smart Energy, 1 can, administered acutely Receives: Dietary Supplement: Energy drink consumption |
| Reduced Citicoline Energy Drink | Experimental | C4 Smart Energy Reduced Citicoline, 1 can, administered acutely Receives: Dietary Supplement: Energy drink consumption |
| Reduced Citicoline and Caffeine Energy Drink | Experimental | C4 Smart Energy Reduced Citicoline and Caffeine, 1 can, administered acutely Receives: Dietary Supplement: Energy drink consumption |
| Placebo | Placebo comparator | Placebo 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.
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
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
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)
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
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:
- 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
- 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
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
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:
- 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
- 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
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
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
Total Mood Disturbance
Total mood disturbance will be quantified using the Profile of Mood State Short Form Questionnaire.
Measured: 105-minutes post-drink consumption
Vigor-Activity
Vigor will be quantified using the Profile of Mood State Short Form
Measured: 105-minutes post-drink consumption
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
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.
- First posted24 Mar 2025
- Study start9 Jun 2023
- Primary completion1 Dec 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive PerformanceStudies 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
- 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)
Sponsor and investigators
- Lead sponsor
- Nathaniel Jenkins
- Sponsor type
- University, hospital or other
- Collaborators
- Woodbolt Distribution
- Responsible party
- Sponsor-investigator, Nathaniel Jenkins, University of Iowa
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06890962
- Acronym / sponsor ID
- 202302574
- Conditions
- Cognitive Performance, Gaming Performance, Blood Pressure, Heart Rate, Mood
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Nathaniel JenkinsUniversity, hospital or other
- Collaborators
- Woodbolt Distribution
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 24 Mar 2025 (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 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?
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 4 condition, randomized cross-over with 3-7 day washout between conditions
| Arm | Type | Receives |
|---|---|---|
| Standard Energy Drink | Active comparator | Dietary Supplement: Energy drink consumptionC4 Smart Energy, 1 can, administered acutely |
| Reduced Citicoline Energy Drink | Experimental | Dietary Supplement: Energy drink consumptionC4 Smart Energy Reduced Citicoline, 1 can, administered acutely |
| Reduced Citicoline and Caffeine Energy Drink | Experimental | Dietary Supplement: Energy drink consumptionC4 Smart Energy Reduced Citicoline and Caffeine, 1 can, administered acutely |
| Placebo | Placebo comparator | Dietary Supplement: Energy drink consumptionPlacebo Drink devoid of active ingredients, 1 can, administered acutely |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Fitness: Healthy, recreationally trained (>2 d/wk physical activity)
- BMI: (<30kg/m2) or BF <25% (M) and <32% (F)
Key exclusion criteria (11 listed)
- <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
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 |
|---|---|---|
| Energy drink consumptionParticipants will consume an energy drink (or placebo) and then undergo experimental testing after a 40 minute rest period following drink consumption. | Dietary supplement | Placebo, Reduced Citicoline Energy Drink, Reduced Citicoline and Caffeine Energy Drink, Standard Energy Drink |
Primary outcome
Executive Function
Time frame: 60 minutes post-drink consumption
How well a subject recognizes rules, categories, and manages or navigates rapid decision making. Assessed as Shifting Attention Task (SAT) Correct Responses - SAT Errors.
Resting Fat Oxidation
Time frame: 50 minutes post-drink consumption
Resting fat oxidation (g/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.
Video Game Performance
Time frame: 90 minutes post-drink consumption
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.
10 secondary outcomes
Sustained Attention
Time frame: 60 minutes post-drink consumption
Psychomotor Speed
Time frame: 60 minutes post-drink consumption
Working Memory
Time frame: 60 minutes post-drink consumption
Cognitive Flexibility
Time frame: 60 minutes post-drink consumption
Resting Metabolic Rate
Time frame: 50 minutes post-drink consumption
Resting Respiratory Exchange Ratio
Time frame: 50 minutes post-drink consumption
Total Mood Disturbance
Time frame: 105-minutes post-drink consumption
Vigor-Activity
Time frame: 105-minutes post-drink consumption
Heart rate
Time frame: pre-drink consumption, 40-minutes post-drink consumption, 110 minutes post-drink consumption
Blood Pressure
Time frame: pre-drink consumption, 40 minutes post-drink consumption, 110 minutes post-drink consumption
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 24 Mar 2025.
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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 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.