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临床试验/NCT06890962
NCT06890962已完成不适用

The Effect of Citicoline and Caffeine Dose in a Commercial Energy Drink on Cognitive Performance, Energy Expenditure and Fat Oxidation in Young Adults

Nathaniel Jenkins2 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2023年6月9日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
34
试验地点
2
主要终点
Executive Function

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • <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

结局指标

主要结局

Executive Function

时间窗: 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

时间窗: 50 minutes post-drink consumption

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

Video Game Performance

时间窗: 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.

次要结局

  • 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)
  • Resting Respiratory Exchange Ratio(50 minutes post-drink consumption)
  • Vigor-Activity(105-minutes post-drink consumption)
  • Total Mood Disturbance(105-minutes post-drink consumption)
  • Heart rate(pre-drink consumption, 40-minutes post-drink consumption, 110 minutes post-drink consumption)
  • Blood Pressure(pre-drink consumption, 40 minutes post-drink consumption, 110 minutes post-drink consumption)

研究者

申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Nathaniel Jenkins

Assistant Professor, Principal Investigator

University of Iowa

研究点 (2)

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