HealthyNCT05503732
Effects of Energy Drinks on Sleep and Cardiovascular Health
A study testing Energy Drink in people with Healthy and Caffeine, run by Mayo Clinic at 1 site in United States.
Trial summary
The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- What is being tested?
- Energy Drink
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2022to 6 Sep 2024
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults 18 years of age and older.
- Healthy subjects without known cardiovascular disease and thyroid disease.
- Subjects who are on no medications (except oral contraceptive pill).
- Nonsmokers.
- No prior history of caffeine sensitivity or allergy.
Who cannot join
- Subjects with known cardiovascular or thyroid disease.
- Subjects currently taking medications other than oral contraceptive pill.
- Smokers.
- Prior history of caffeine sensitivity or allergy.
- Pregnancy.
- Subjects who regularly consume energy drinks.
Show all 11Show fewer
- Subjects who typically go to sleep after midnight.
- Subjects who traveled across 2 time zones in the last 7 days.
- Shift workers.
- Subjects who have or are suspected to have sleep apnea.
- Subjects who have a body mass index > 35kg/m^2.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults A Double Blind Randomized Clinical Trial
The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants.
- Being tested
- Energy Drink, Placebo Drink
- Keywords
- Energy Drink
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy DrinkOther
Two 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed
Placebo DrinkOther
Two 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed
| Study group | Role | What they receive |
|---|---|---|
| Energy drink first, then placebo drink | Experimental | Subjects will consume two 16-oz energy drinks before sleep for the first study visit, then consume two 16-oz identical looking placebo drink before sleep at the second study visit. Receives: Other: Energy Drink; Other: Placebo Drink |
| Placebo drink first, than energy drink | Experimental | Subjects will consume two 16-oz identical looking placebo drink before sleep at the fist study visit, then consume two 16-oz energy drinks before sleep for the second study visit. Receives: Other: Energy Drink; Other: Placebo Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in sleep efficiency
Time asleep / time in bed
Measured: Throughout duration of sleep on both nights (night 1 and night 2)
Changes in sleep continuity
Frequency of wakefulness after sleep initiation
Measured: Throughout duration of sleep on both nights (night 1 and night 2)
Changes in sleep architecture
Time spent in each stage of sleep
Measured: Throughout duration of sleep on both nights (night 1 and night 2)
QT segment
QT duration
Measured: Baseline, approximately 1 hour prior to energy drink consumption
QT segment
QT duration
Measured: Throughout duration of sleep on both nights (night 1 and night 2)
Atrial arrhythmias
Frequency of ectopic atrial beats
Measured: Baseline, approximately 1 hour prior to energy drink consumption
Atrial arrhythmias
Frequency of ectopic atrial beats
Measured: Throughout duration of sleep on both nights (night 1 and night 2)
Ventricular arrhythmias
Frequency of ectopic ventricular beats
Measured: Baseline, approximately 1 hour prior to energy drink consumption
Ventricular arrhythmias
Frequency of ectopic ventricular beats
Measured: Throughout duration of sleep on both nights (night 1 and night 2)
Secondary outcomes (6)
Sympathetic activation quantified by changes in plasma norepinephrine
Plasma norepinephrine while supine
Measured: Baseline and AM of day 2
Sympathetic activation quantified by changes in plasma epinephrine
Plasma epinephrine while supine
Measured: Baseline and AM of day 2
Sympathetic activation quantified by changes in plasma dopamine
Plasma dopamine while supine
Measured: Baseline and AM of day 2
Sympathetic activation quantified by urine norepinephrine
Total urine norepinephrine secretion
Measured: Approximately 24 hours
Sympathetic activation quantified by urine epinephrine
Total urine epinephrine secretion
Measured: Approximately 24 hours
Sympathetic activation quantified by urine dopamine
Total urine dopamine secretion
Measured: Approximately 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2022
- Study start1 Sep 2022
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Svatikova, Mayo Clinic
- Investigators
- Anna Svatikova, MD, PhD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05503732
- Sponsor's protocol ID
- 21-012902
- Status last verified
- Nov 2024
- First submitted
- 14 Jul 2022
- Last updated
- 15 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Energy Drinks on Sleep and Cardiovascular Health in Healthy Young Adults A Double Blind Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05503732
- Acronym / sponsor ID
- 21-012902
- Keywords
- Energy Drink
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 17 Aug 2022 (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.
The purpose of this study is to learn about the change in quality of sleep, structural organization of sleep, and cardiovascular responses after consuming an energy drink compared to a placebo drink with no caffeine or stimulants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Energy drink first, then placebo drink | Experimental | Other: Energy Drink, Other: Placebo DrinkSubjects will consume two 16-oz energy drinks before sleep for the first study visit, then consume two 16-oz identical looking placebo drink before sleep at the second study visit. |
| Placebo drink first, than energy drink | Experimental | Other: Energy Drink, Other: Placebo DrinkSubjects will consume two 16-oz identical looking placebo drink before sleep at the fist study visit, then consume two 16-oz energy drinks before sleep for the second study visit. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults 18 years of age and older.
- Healthy subjects without known cardiovascular disease and thyroid disease.
- Subjects who are on no medications (except oral contraceptive pill).
- Nonsmokers.
- No prior history of caffeine sensitivity or allergy.
Key exclusion criteria (11 listed)
- Subjects with known cardiovascular or thyroid disease.
- Subjects currently taking medications other than oral contraceptive pill.
- Smokers.
- Prior history of caffeine sensitivity or allergy.
- Pregnancy.
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 DrinkTwo 16-oz energy drinks consumed orally to be finished approximately 4 hours prior to bed | Other | Energy drink first, then placebo drink, Placebo drink first, than energy drink |
| Placebo DrinkTwo 16-oz identical looking placebo drink without caffeine consumed orally to be finished approximately 4 hours prior to bed | Other | Energy drink first, then placebo drink, Placebo drink first, than energy drink |
Primary outcome
Changes in sleep efficiency
Time frame: Throughout duration of sleep on both nights (night 1 and night 2)
Time asleep / time in bed
Changes in sleep continuity
Time frame: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of wakefulness after sleep initiation
Changes in sleep architecture
Time frame: Throughout duration of sleep on both nights (night 1 and night 2)
Time spent in each stage of sleep
QT segment
Time frame: Baseline, approximately 1 hour prior to energy drink consumption
QT duration
QT segment
Time frame: Throughout duration of sleep on both nights (night 1 and night 2)
QT duration
Atrial arrhythmias
Time frame: Baseline, approximately 1 hour prior to energy drink consumption
Frequency of ectopic atrial beats
Atrial arrhythmias
Time frame: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of ectopic atrial beats
Ventricular arrhythmias
Time frame: Baseline, approximately 1 hour prior to energy drink consumption
Frequency of ectopic ventricular beats
Ventricular arrhythmias
Time frame: Throughout duration of sleep on both nights (night 1 and night 2)
Frequency of ectopic ventricular beats
6 secondary outcomes
Sympathetic activation quantified by changes in plasma norepinephrine
Time frame: Baseline and AM of day 2
Sympathetic activation quantified by changes in plasma epinephrine
Time frame: Baseline and AM of day 2
Sympathetic activation quantified by changes in plasma dopamine
Time frame: Baseline and AM of day 2
Sympathetic activation quantified by urine norepinephrine
Time frame: Approximately 24 hours
Sympathetic activation quantified by urine epinephrine
Time frame: Approximately 24 hours
Sympathetic activation quantified by urine dopamine
Time frame: Approximately 24 hours
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 15 Nov 2024.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Anna Svatikova, MD, PhD principal investigator
Mayo Clinic
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 Healthy and Caffeine, run by Mayo Clinic at 1 site in United States.
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 5 inclusion and 11 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 15 Nov 2024. 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 United States. 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?
Changes in sleep efficiency (time frame: Throughout duration of sleep on both nights (night 1 and night 2)). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Nov 2024.