Clinical trial NCT06890962: Citicoline Dose on Energy Drink Efficacy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Performance
Gaming Performance
Blood Pressure
Heart Rate
Mood
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: Woodbolt Distribution
First posted: 2025-03-24
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: 4 condition, randomized cross-over with 3-7 day washout between conditions
Primary purpose: OTHER

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.


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

Primary outcomes:
measure: Executive Function
timeFrame: 60 minutes post-drink consumption
measure: Resting Fat Oxidation
timeFrame: 50 minutes post-drink consumption
measure: Video Game Performance
timeFrame: 90 minutes post-drink consumption
Secondary outcomes:
measure: Sustained Attention
timeFrame: 60 minutes post-drink consumption
measure: Psychomotor Speed
timeFrame: 60 minutes post-drink consumption
measure: Working Memory
timeFrame: 60 minutes post-drink consumption
measure: Cognitive Flexibility
timeFrame: 60 minutes post-drink consumption
measure: Resting Metabolic Rate
timeFrame: 50 minutes post-drink consumption
measure: Resting Respiratory Exchange Ratio
timeFrame: 50 minutes post-drink consumption
measure: Total Mood Disturbance
timeFrame: 105-minutes post-drink consumption
measure: Vigor-Activity
timeFrame: 105-minutes post-drink consumption
measure: Heart rate
timeFrame: pre-drink consumption, 40-minutes post-drink consumption, 110 minutes post-drink consumption
measure: Blood Pressure
timeFrame: pre-drink consumption, 40 minutes post-drink consumption, 110 minutes post-drink consumption
Other outcomes:
measure: Tension
timeFrame: 105 minutes post-drink consumption
measure: Fatigue
timeFrame: 105 minutes post-drink consumption
measure: Anger
timeFrame: 105 minutes post-drink consumption
measure: Confusion
timeFrame: 105 minutes post-drink consumption
measure: Friendliness
timeFrame: 105 minutes post-drink consumption
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
References: