Health Effect of Energy Drink Consumption

September 15, 2022 updated by: SM Ashraf Jahangeer, Dow University of Health Sciences

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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%.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • None Selected
      • Karachi, None Selected, Pakistan, 74200
        • Dow University of Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: energy drink arm
an open label branded energy drink which contains any one or more of the following ingredients: caffeine, ginseng, taurine
Other: energy drink
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.
ACTIVE_COMPARATOR: tea 5gm sugar arm
the usual easily available black tea with sugar 5 grams, and milk
Other: energy drink
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
half hour post consumption
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
half hour post consumption
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
half hour post consumption
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
half hour post consumption

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within one hour of consumption of the energy drink or the active comparator

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dow University of Health Sciences

Investigators

  • Principal Investigator: Syed Muhammad Ashraf Jahangeer, Dow University of Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 29, 2021

Primary Completion (ACTUAL)

February 28, 2022

Study Completion (ACTUAL)

September 1, 2022

Study Registration Dates

First Submitted

June 28, 2021

First Submitted That Met QC Criteria

July 1, 2021

First Posted (ACTUAL)

July 14, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CHS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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