Health Effect of Energy Drink Consumption

Dow University of Health Sciences

Status: Completed

Conditions: Blood Glucose, High; Cognitive Change; Blood Pressure

Treatments: Other: energy drink

Study type: Interventional

Funder types: Other

Identifiers

NCT04961086

CHS001

Details and patient eligibility

About

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

Full 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%.

Enrollment: 76 patients

Sex: All

Ages: 18 to 30 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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76 participants in 2 patient groups

energy drink arm

Experimental group

Description:

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

Treatment:

Other: energy drink

tea 5gm sugar arm

Active Comparator group

Description:

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

Treatment:

Other: energy drink