Citicoline Dose on Energy Drink Efficacy

NCT06890962 | Completed

• 1 other identifier: 202302574
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Performance; Gaming Performance; Blood Pressure; Heart Rate; Mood

Outcome Measures

Primary Outcomes (3)

• 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.

  60 minutes post-drink consumption

• Resting Fat Oxidation

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

  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.

  90 minutes post-drink consumption

Secondary Outcomes (10)

• Sustained Attention

  60 minutes post-drink consumption

• Psychomotor Speed

  60 minutes post-drink consumption

• Working Memory

  60 minutes post-drink consumption

• Cognitive Flexibility

  60 minutes post-drink consumption

• Resting Metabolic Rate

  50 minutes post-drink consumption

Other Outcomes (5)

• Tension

  105 minutes post-drink consumption

• Fatigue

  105 minutes post-drink consumption

• Anger

  105 minutes post-drink consumption

Study Arms (4)

Standard Energy Drink

ACTIVE COMPARATOR

C4 Smart Energy, 1 can, administered acutely

Dietary Supplement: Energy drink consumption

Reduced Citicoline Energy Drink

EXPERIMENTAL

C4 Smart Energy Reduced Citicoline, 1 can, administered acutely

Dietary Supplement: Energy drink consumption

Reduced Citicoline and Caffeine Energy Drink

EXPERIMENTAL

C4 Smart Energy Reduced Citicoline and Caffeine, 1 can, administered acutely

Dietary Supplement: Energy drink consumption

Placebo

PLACEBO COMPARATOR

Placebo Drink devoid of active ingredients, 1 can, administered acutely

Dietary Supplement: Energy drink consumption

Interventions

Energy drink consumption DIETARY_SUPPLEMENT

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

Placebo; Reduced Citicoline Energy Drink; Reduced Citicoline and Caffeine Energy Drink; Standard Energy Drink

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• \<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

Sponsors & Collaborators

• Nathaniel Jenkins: lead
• Woodbolt Distribution: collaborator

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Model Details: 4 condition, randomized cross-over with 3-7 day washout between conditions

Study Record Dates

• First Submitted: June 3, 2024
• First Posted: March 24, 2025
• Study Start: June 9, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: March 24, 2025

Record last verified: 2025-03

Locations

US (1)