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临床试验/NCT02727920
NCT02727920已完成不适用

A Test of the Effects of Energy Drinks

Johns Hopkins Bloomberg School of Public Health2 个研究点 分布在 1 个国家目标入组 228 人开始时间: 2016年4月2日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
228
试验地点
2
主要终点
attention-memory score

研究概览

简要总结

This study is designed to test the efficacy of energy drinks. This is a double-blinded, crossover, randomized clinical trial, measuring the effect of the test drinks compared with placebo drink in 200 participants aged 18-70 years.

详细描述

This study is designed to test the efficacy of an energy drink compared to placebo via a double-blind, crossover, randomized clinical trial. Energy levels will be assessed before and after consumption of the test beverages on 2 days separated by a week in 200 participants aged 18-70 years. The study is crossover because the participants will be (randomly) receiving one drink on Test Day 1 and the other drink on Test Day 2.

After signing written informed consent, participants will be fed a light lunch, and their pulse, weight and height measured. A baseline battery of computer-based tests to assess energy levels will be conducted. These computer-based measures will take ~40 minutes to complete and will include: a) a long-term memory test b) a Profile of Mood States (POMS2) brief form; c) Rapid Visual Information Processing (RVIP) test, d) The N-Back Task; d) Reaction time online test; f) the Flanker Task. Participants will then be asked to fill out a baseline survey (30 min), with questions about current health-related behaviors, specifically questions about physical activity and diet.

Upon completing the baseline battery (survey administered at test session 1 only), participants will be randomly administered the energy drink or the placebo to consume while observed. Subsequently, the battery of computer-based tests to assess energy levels will be re-administered 30 minutes, 2.5 hours and 5 hours after consumption of the test drink.

The study intervention will be double-blinded: participants will be blinded to whether they are receiving the active or the placebo drink, and study team members will also not be aware of the assignment.

When the study ends, full compensation will be given if the intervention is fully completed; if the intervention is not fully completed, partial compensation will be given.

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
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Fluent in reading English
  • High school graduate as lowest education level

排除标准

  • Non-smoker
  • No diagnosed/treated cognitive/psychiatric conditions by self-report
  • No diagnosed/treated diabetes, hypoglycemia or thyroid condition by self-report
  • No current use of prescription stimulant medications by self-report
  • No allergies or sensitivities to foods, ingredients or chemicals by self-report, that are contained in the test drink or placebo
  • No diagnosed phenylketonuria

研究组 & 干预措施

Experimental

Experimental

drink containing pyridoxine, folate; B12); taurine, choline, glucuronic acid; tyrosine, phenylalanine*, malic acid, and caffeine administered one time.

干预措施: Energy drink (Dietary Supplement)

Placebo drink

Placebo Comparator

Placebo drink administered one time.

干预措施: Placebo (Other)

结局指标

主要结局

attention-memory score

时间窗: 5 hours

Comparing intervention to placebo results on attention-memory score

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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