Citicoline Dose on Energy Drink Efficacy

NCT ID: NCT06890962

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-09
• Study Completion Date: 2023-12-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: TRIPLE

Study Groups

Standard Energy Drink

C4 Smart Energy, 1 can, administered acutely

Group Type: ACTIVE_COMPARATOR

Energy drink consumption

Intervention Type: DIETARY_SUPPLEMENT

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

Reduced Citicoline Energy Drink

C4 Smart Energy Reduced Citicoline, 1 can, administered acutely

Group Type: EXPERIMENTAL

Energy drink consumption

Intervention Type: DIETARY_SUPPLEMENT

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

Reduced Citicoline and Caffeine Energy Drink

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

Group Type: EXPERIMENTAL

Energy drink consumption

Intervention Type: 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

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

Group Type: PLACEBO_COMPARATOR

Energy drink consumption

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Energy drink consumption

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Woodbolt Distribution

UNKNOWN

Sponsor Role: collaborator

Nathaniel Jenkins

OTHER

Sponsor Role: lead

Responsible Party

Nathaniel Jenkins

Assistant Professor, Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

University of Iowa

Iowa City, Iowa, United States

Countries

United States

Other Identifiers

202302574

Identifier Type: -

Identifier Source: org_study_id