Blood PressureNCT04961086
Health Effect of Energy Drink Consumption
A study testing energy drink in people with Blood Pressure and Blood Glucose, High, run by Dow University of Health Sciences at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Blood Pressure, Blood Glucose, High, Cognitive Change
- What is being tested?
- energy drink
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 29 Jun 2021to 1 Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult volunteers aged between 18-30 years
- Either gender
- Willing to participate
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Pakistan1 site
Dow University of Health Sciences
Karachi, None Selected, 74200
About this study
Official title: 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:
- To determine the effect of consumption of energy drinks on hemodynamics parameters.
- To determine the effect of consumption of energy drinks on short term memory
- To determine the effect of consumption of energy drinks on vigilance in adults
- To determine the effect of consumption of energy drinks on blood glucose in adults
- To analyze the effect of energy drink on perception in adults
Read the 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%.
- Conditions
- Blood Pressure, Blood Glucose, High, Cognitive Change
- Being tested
- energy drink
- Keywords
- energy drink, hemodynamics, memory, stroop test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
energy drinkOther
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.
| Study group | Role | What they receive |
|---|---|---|
| energy drink arm | Experimental | an open label branded energy drink which contains any one or more of the following ingredients: caffeine, ginseng, taurine Receives: Other: energy drink |
| tea 5gm sugar arm | Active comparator | the usual easily available black tea with sugar 5 grams, and milk Receives: Other: energy drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: half hour post consumption
Secondary outcomes (1)
perceptions and knowledge of participants about energy drinks
simple questions from the participants about the effects and composition of energy drinks
Measured: within one hour of consumption of the energy drink or the active comparator
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start29 Jun 2021
- Primary completion28 Feb 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dow University of Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, SM Ashraf Jahangeer, Dow University of Health Sciences
- Investigators
- Syed Muhammad Ashraf Jahangeer, Principal investigator, Dow University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04961086
- Sponsor's protocol ID
- CHS001
- Status last verified
- Sep 2022
- First submitted
- 28 Jun 2021
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26184263Nowak 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.
PubMed 29562659Wesnes 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.
PubMed 28168925Buckenmeyer 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.
PubMed 26394126Smith 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.
PubMed 29947575Brothers 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.
PubMed 26931509
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Consumption of Energy Drinks on Hemodynamics, Blood Glucose, Short Term Memory, Vigilance and Perception in Healthy Adults
- ClinicalTrials.gov ID
- NCT04961086
- Acronym / sponsor ID
- CHS001
- Conditions
- Blood Pressure, Blood Glucose, High, Cognitive Change
- Keywords
- energy drink, hemodynamics, memory, stroop test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Dow University of Health SciencesUniversity, hospital or other
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To determine the effect of consumption of energy drinks on hemodynamics parameters.
- To determine the effect of consumption of energy drinks on short term memory
- To determine the effect of consumption of energy drinks on vigilance in adults
- To determine the effect of consumption of energy drinks on blood glucose in adults
- 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%.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| energy drink arm | Experimental | Other: energy drinkan open label branded energy drink which contains any one or more of the following ingredients: caffeine, ginseng, taurine |
| tea 5gm sugar arm | Active comparator | Other: energy drinkthe usual easily available black tea with sugar 5 grams, and milk |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Adult volunteers aged between 18-30 years
- Either gender
- Willing to participate
Key exclusion criteria (6 listed)
- Known cardiovascular diseases
- Under any medication
- Known Diabetes mellitus or any other chronic disease
- Pregnancy or lactation
- History of neurological disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| energy drinkAn 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. | Other | energy drink arm, tea 5gm sugar arm |
Primary outcome
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
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
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
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
1 secondary outcome
perceptions and knowledge of participants about energy drinks
Time frame: within one hour of consumption of the energy drink or the active comparator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2022.
- Results publication: PubMed 26184263Nowak 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.
- Results publication: PubMed 29562659Nowak 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.
- Results publication: PubMed 28168925Wesnes 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.
- Results publication: PubMed 26394126Buckenmeyer 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.
- Results publication: PubMed 29947575Smith 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.
- Results publication: PubMed 26931509Brothers 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.
- Individual participant dataSharing planned: No
Related trials for Blood Pressure
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
RecruitingPhase 3
A Phase III Renal Outcomes and Cardiovascular Mortality Study to Investigate the Efficacy and Safety of Baxdrostat in Combination With Dapagliflozin in Participants With Chronic Kidney Disease and High Blood Pressure
Chronic Kidney Disease and Hypertension
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingPhase 4
Hematological Safety of Dipyrone Versus Paracetamol After Dental Extractions
Hematologic Test, Agranulocytosis
Not yet recruiting
Acute Effects of Mat Pilates on Blood Pressure Response to Mental Stress in Higher Education Teachers
Behavior
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Syed Muhammad Ashraf Jahangeer principal investigator
Dow University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing energy drink in people with Blood Pressure and Blood Glucose, High, run by Dow University of Health Sciences at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in systolic and diastolic blood pressure (time frame: half hour post consumption). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04961086, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2022.