NCT04961086

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 28, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

June 29, 2021

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 14, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2022

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

September 16, 2022

Status Verified

September 1, 2022

Enrollment Period

8 months

First QC Date

June 28, 2021

Last Update Submit

September 15, 2022

Conditions

Keywords

energy drinkhemodynamicsmemorystroop test

Outcome Measures

Primary Outcomes (4)

  • Change in systolic and diastolic blood pressure

    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

    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

    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

    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 Outcomes (1)

  • perceptions and knowledge of participants about energy drinks

    within one hour of consumption of the energy drink or the active comparator

Study Arms (2)

energy drink arm

EXPERIMENTAL

an open label branded energy drink which contains any one or more of the following ingredients: caffeine, ginseng, taurine

Other: energy drink

tea 5gm sugar arm

ACTIVE COMPARATOR

the usual easily available black tea with sugar 5 grams, and milk

Other: energy drink

Interventions

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.

energy drink armtea 5gm sugar arm

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dow University of Health Sciences

Karachi, None Selected, 74200, Pakistan

Location

Related Publications (6)

  • Nowak D, Jasionowski A. Analysis of the Consumption of Caffeinated Energy Drinks among Polish Adolescents. Int J Environ Res Public Health. 2015 Jul 10;12(7):7910-21. doi: 10.3390/ijerph120707910.

  • Nowak D, Goslinski M, Nowatkowska K. The Effect of Acute Consumption of Energy Drinks on Blood Pressure, Heart Rate and Blood Glucose in the Group of Young Adults. Int J Environ Res Public Health. 2018 Mar 19;15(3):544. doi: 10.3390/ijerph15030544.

  • Wesnes KA, Brooker H, Watson AW, Bal W, Okello E. Effects of the Red Bull energy drink on cognitive function and mood in healthy young volunteers. J Psychopharmacol. 2017 Feb;31(2):211-221. doi: 10.1177/0269881116681459. Epub 2016 Dec 14.

  • Buckenmeyer PJ, Bauer JA, Hokanson JF, Hendrick JL. Cognitive influence of a 5-h ENERGY(R) shot: Are effects perceived or real? Physiol Behav. 2015 Dec 1;152(Pt A):323-7. doi: 10.1016/j.physbeh.2015.09.003. Epub 2015 Sep 21.

  • Smith AP, Richards G. Energy drinks, caffeine, junk food, breakfast, depression and academic attainment of secondary school students. J Psychopharmacol. 2018 Aug;32(8):893-899. doi: 10.1177/0269881118783314. Epub 2018 Jun 27.

  • Brothers RM, Christmas KM, Patik JC, Bhella PS. Heart rate, blood pressure and repolarization effects of an energy drink as compared to coffee. Clin Physiol Funct Imaging. 2017 Nov;37(6):675-681. doi: 10.1111/cpf.12357. Epub 2016 Mar 1.

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Syed Muhammad Ashraf Jahangeer

    Dow University of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

June 28, 2021

First Posted

July 14, 2021

Study Start

June 29, 2021

Primary Completion

February 28, 2022

Study Completion

September 1, 2022

Last Updated

September 16, 2022

Record last verified: 2022-09

Data Sharing

IPD Sharing
Will not share

Locations