Citicoline Dose on Energy Drink Efficacy

Not Applicable

Completed

• Conditions: Cognitive Performance; Gaming Performance; Blood Pressure; Heart Rate; Mood

• Registration Number: NCT06890962
• Lead Sponsor: Nathaniel Jenkins

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-06-09
• Primary Completion: 2023-12-01
• Study Completion: 2023-12-01
• Study First Submitted: 2024-06-03
• Status Verified: 2025-03
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-25
• Last Update Posted: 2025-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

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

Exclusion Criteria

• <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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Executive Function	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	50 minutes post-drink consumption	Resting fat oxidation (g/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.
Video Game Performance	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.

Secondary Outcome Measures

Name	Time	Method
Sustained Attention	60 minutes post-drink consumption	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)
Psychomotor Speed	60 minutes post-drink consumption	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
Working Memory	60 minutes post-drink consumption	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
Cognitive Flexibility	60 minutes post-drink consumption	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
Resting Metabolic Rate	50 minutes post-drink consumption	Resting metabolic rate (kcal/min) will be quantified from resting, fasted analyses of pulmonary gas exchange.
Resting Respiratory Exchange Ratio	50 minutes post-drink consumption	Resting respiratory exchange ratio will be quantified from resting, fasted analyses of pulmonary gas exchange.
Vigor-Activity	105-minutes post-drink consumption	Vigor will be quantified using the Profile of Mood State Short Form
Total Mood Disturbance	105-minutes post-drink consumption	Total mood disturbance will be quantified using the Profile of Mood State Short Form Questionnaire.
Heart rate	pre-drink consumption, 40-minutes post-drink consumption, 110 minutes post-drink consumption	Heart rate will be quantified from a standard 3-lead ECG
Blood Pressure	pre-drink consumption, 40 minutes post-drink consumption, 110 minutes post-drink consumption	Systolic, diastolic, and pulse pressures (mmHg) will be quantified from brachial

Trial Locations

Locations (1)

University of Iowa; 🇺🇸 Iowa City, Iowa, United States