Clinical trial NCT04961086: Health Effect of Energy Drink Consumption
Official title: Effect of Consumption of Energy Drinks on Hemodynamics, Blood Glucose, Short Term Memory, Vigilance and Perception in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Blood Glucose, High
Cognitive Change
Keywords: energy drink
hemodynamics
memory
stroop test
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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. 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

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%.

Eligibility criteria: 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

Primary outcomes:
measure: Change in systolic and diastolic blood pressure
timeFrame: half hour post consumption
measure: Change in heart rate
timeFrame: half hour post consumption
measure: Change in blood glucose
timeFrame: half hour post consumption
measure: Change in short-term memory and vigilance
timeFrame: half hour post consumption
Secondary outcomes:
measure: perceptions and knowledge of participants about energy drinks
timeFrame: within one hour of consumption of the energy drink or the active comparator
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dow University of Health Sciences
state: None Selected
Study officials:
affiliation: Dow University of Health Sciences
name: Syed Muhammad Ashraf Jahangeer
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.