Short term effects of low caffeine energy drinks on blood vessel and heart functions in healthy volunteers
| ISRCTN | ISRCTN40313372 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN40313372 |
| Secondary identifying numbers | ED-0001 |
- Submission date
- 17/10/2021
- Registration date
- 19/10/2021
- Last edited
- 19/10/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Caffeine is a natural stimulant most commonly found in tea, coffee, and cacao plants. It works by stimulating the brain and central nervous system, helping you stay alert and prevent the onset of tiredness.
High caffeine content energy drinks are known to have adverse health effects. Turkish law restricts the caffeine and taurine content of energy drinks.
This study aims to investigate the short-term effects of energy drinks on heart and blood vessel function.
Who can participate?
The study is open to healthy volunteers 18-50 years of age who are not heavy smokers or heavy caffeine consumers.
What does the study involve?
The volunteers will be given a 355 ml can of Red Bull energy drink containing 53.25 mg of caffeine and their measurements will be recorded before and after the energy drink consumption. They will also be given a control drink (mixed fruit juice) in another session where their measurements will also be recorded.
What are the possible benefits and risks of participating?
This study investigates the acute effects of commercially available limited caffeine energy drinks on heart and vessel functions. The results of the study might shed light on the potential benefits of restricting the caffeine and taurine content of commercially available energy drinks. The participants will drink only 355 ml of the study drinks once. There are no potential risks for participating in this study.
Where is the study run from?
Ankara University School of Medicine Cardiology Department (Turkey)
When is the study starting and how long is it expected to run for?
March 2014 to January 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Dr Cansin Tulunay Kaya, kayac@ankara.edu.tr
Contact information
Scientific
Ankara University School of Medicine Department of Cardiology Samanpazarı
Ankara
06100
Türkiye
 ORCID ID |
0000-0002-1168-9005 |
|---|---|
| Phone | +90 3125082778 |
| kayac@ankara.edu.tr |
Study information
| Study design | Single center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Acute effects of low caffeine energy drinks on endothelial and myocardial functions in healthy volunteers |
| Study objectives | Restricted caffeine and taurine content energy drinks might effect the endothelial functions adversely. Myocardial functions can improve after energy drink consumption |
| Ethics approval(s) | Approved 23/06/2014, Ankara University Clinical Trials Ethics Board (Ankara Universitesi Tip Fakultesi Morfoloji Binasi 06100 Sıhhiye/Ankara, Turkey; +90 312 595 8227; etik@medicine.ankara.edu.tr), ref: 11-484-14 |
| Health condition(s) or problem(s) studied | Determining the effect of energy drink consumption on heart and blood vessel function in healthy volunteers |
| Intervention | The volunteers are assigned to study drinks through online randomization (randomizer.org) , they will be asked to drink 355 ml of one of the study drinks (commercially available energy drink containing 53.25 mg caffeine or control drink which is mixed fruit juice) and crossover to the other in two seperate sessions 7-10 days apart. The study ends after the second session. |
| Intervention type | Other |
| Primary outcome measure | The change in endothelial flow mediated dilation (FMD) is measured before and 60 minutes after energy drink consumption. |
| Secondary outcome measures | The change in myocardial strain levels is measured using Echocardiographic images for 2 dimensional speckle tracking echocardiography of left and right ventricles recorded before and 60 minutes after study drink consumption, which are then analyzed offline by an investigator blind to patient data. |
| Overall study start date | 10/03/2014 |
| Completion date | 01/01/2021 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 34 |
| Total final enrolment | 34 |
| Key inclusion criteria | Healthy volunteers giving informed consent |
| Key exclusion criteria | 1. Any abnormalities in their baseline screening echocardiographic examination 2. Heavy caffeine consumers (>200 mg/day) 3. Smoke >5 cigarettes/day 4. Low BMI (<18.5 kg/m²) or obese individuals (BMI>30 kg/m²) 5. Acute infection |
| Date of first enrolment | 01/08/2014 |
| Date of final enrolment | 01/04/2015 |
Locations
Countries of recruitment
- Türkiye
Study participating centre
Samanpazari
Ankara
06100
Türkiye
Sponsor information
University/education
School of Medicine
Cardiology department
Samanpazari
Ankara
06100
Türkiye
| Phone | +90 3125082523 |
|---|---|
| kardiyo@medicine.ankara.edu.tr | |
| Website | http://en.ankara.edu.tr/ |
"ROR" |
https://ror.org/01wntqw50 |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request from Dr Cansın Tulunay Kaya, kayac@ankara.edu.tr. The data will be anonymized before sharing. |
Editorial Notes
19/10/2021: Trial's existence confirmed by Ankara University Clinical Trials Ethics Board.
