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NCT Number: NCT04961086

Health Effect of Energy Drink Consumption

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

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Key information

Conditions

Blood Pressure Blood Glucose, High Cognitive Change

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dow University of Health Sciences

Karachi, None Selected, 74200, Pakistan

About this study

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%.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult volunteers aged between 18-30 years
  • Either gender
  • Willing to participate

Exclusion criteria

  • 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

Treatment and study plan

Energy drink

Other

An easily available 250 ml branded energy drink will be randomized to the partcipants after informed consent. Before and thirty minutes after drinking the given energy drink the participant cognition, heart rate, blood pressure and blood glucose will be measured.

Primary outcomes

  1. Change in systolic and diastolic blood pressure

    Time frame: 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

  2. Change in heart rate

    Time frame: half hour post consumption

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

  3. Change in blood glucose

    Time frame: 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

  4. Change in short-term memory and vigilance

    Time frame: 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

Secondary outcomes

  1. perceptions and knowledge of participants about energy drinks

    Time frame: within one hour of consumption of the energy drink or the active comparator

    simple questions from the participants about the effects and composition of energy drinks

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 14, 2021
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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