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临床试验/NCT04961086
NCT04961086已完成不适用

Effect of Consumption of Energy Drinks on Hemodynamics, Blood Glucose, Short Term Memory, Vigilance and Perception in Healthy Adults

Dow University of Health Sciences2 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2021年6月29日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
76
试验地点
2
主要终点
Change in heart rate

研究概览

简要总结

Energy drinks consumption has varied effects on the hemodynamic, blood glucose levels, brain functions and memory. The use of energy drinks is pervasive and especially young adults consume it often as binge drinking. The negative health effects of excessive use of energy drinks has been reported in the scientific literature. Often energy drinks are consumed to enhance alertness and cognition improvement. In this trial, the investigators intend to compare the effects of a widely available energy drink brand in the country with the usual black tea with 5gm sugar and milk. The aims of this study is:

  1. To determine the effect of consumption of energy drinks on hemodynamics parameters.
  2. To determine the effect of consumption of energy drinks on short term memory
  3. To determine the effect of consumption of energy drinks on vigilance in adults
  4. To determine the effect of consumption of energy drinks on blood glucose in adults
  5. To analyze the effect of energy drink on perception in adults

详细描述

The participants will be halved in two groups: control group (consuming tea with 5gm of sugar only) and experimental group (consuming energy drinks only) to acquire data regarding fluctuations in hemodynamic parameters including heart rate (HR) and blood pressure (BP)-systolic and diastolic (SBP and DBP) by measuring them before and after 30 minutes of the consumption of tea with 5gm of sugar or energy drink in control or experimental groups. In addition blood glucose level will be monitored in both the groups via glucometer before and after. Reactions of energy drinks in comparison to tea on their respective groups will also be analyzed by help of a stroop test (where the name of the color itself does not match the ink of the color in which it is printed) for understanding its impact on cognitive strengths and on memory by a minor sequence learning game controlled by time lapse. After these interventions participants will be requested to fill out the questionnaire.

The investigatorsare aiming for a sample size of 76 participants, 38 in each of the two groups.

Data will be entered and analyzed in Statistical Package for the Social Sciences version 20 or above. Mean and SD will be calculated for variables such as age, weight, blood pressure (Systolic and Diastolic) and heart rate, blood glucose and Stroop Test score. For qualitative variables such as sex, co morbidity e.g. heart disease, hypertension, family history will be presented as absolute frequencies and proportions. The hemodynamic parameters will be recorded before and after consumption of energy drinks in the intervention and the control group. Independent samples student t-test will be used to compare mean values of hemodynamic parameter between intervention and control group. Significance level of 5% will be set for the study keeping power at 80%.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • Known cardiovascular diseases
  • Under any medication
  • Known Diabetes mellitus or any other chronic disease
  • Pregnancy or lactation
  • History of neurological disorders
  • History of regular alcohol consumption

结局指标

主要结局

Change in heart rate

时间窗: half hour post consumption

before and after consumption of the energy drink or the tea heart rate will be measured as per international guidelines

Change in blood glucose

时间窗: half hour post consumption

before and after consumption of the energy drink or the tea blood glucose levels will be measured as per international guidelines

Change in systolic and diastolic blood pressure

时间窗: half hour post consumption

before and after consumption of the energy drink or the tea both systolic and diastolic blood pressures will be measured as per international guidelines for measuring BP

Change in short-term memory and vigilance

时间窗: half hour post consumption

before and after consumption of the energy drink or the tea short term memory functions will be measured using color sequence game. We will use STROOP test to assess vigilance

次要结局

  • perceptions and knowledge of participants about energy drinks(within one hour of consumption of the energy drink or the active comparator)

研究者

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

SM Ashraf Jahangeer

Doctor

Dow University of Health Sciences

研究点 (2)

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