Healthy VolunteersNCT01329679

Impact of Energy Drinks on Cardiovascular Endpoints

A study testing Energy Drink in people with Healthy Volunteers, run by David Grant U.S. Air Force Medical Center.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects. Study design: Double blind, placebo controlled, cross-over Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions. Read more about this study

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Volunteers
What is being tested?: Energy Drink
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 26 participants
Where: No sites listed yet
Study dates: Apr 2011to Jul 2013
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

Healthy volunteers between ages 18-40 years
ONLY "as needed" use of ibuprofen or acetamenophen
Active duty military
DoD beneficiary or Civilian Government Employees

Who cannot join

No other co-morbid conditions
No active prescription or OTC drug use
Not pregnant or planning to become pregnant during study participation

About this study

Official title: Effects of Single and Multiple Energy Shots on Blood Pressure and Electrocardiographic Parameters: A Randomized, Double Blind, Crossover, Placebo-controlled Trial

Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure

Conditions: Healthy Volunteers
Being tested: Energy Drink, Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Energy DrinkDietary supplement
Energy drink, 2oz twice daily for 7 days
PlaceboOther
Also called Water, lime juice and cherry flavoring
Water, lime juice and cherry flavoring

Study groups in NCT01329679
Study group	Role	What they receive
Energy Drink	Experimental	Energy drink, 2 oz twice daily for 7 days Receives: Dietary Supplement: Energy Drink
Placebo	Placebo comparator	Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Office Systolic Blood Pressure
SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.
Measured: At baseline and 7 days post energy drink and placebo consumption

Secondary outcomes (6)

Office DBP After a Single Energy Shot and After Chronic Consumption
DBP = Diastolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.
Measured: At baseline and 7 days post energy drink and placebo consumption
Max Heart Rate After a Single Shot and After Chronic Consumption
Maximum heart rate measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Measured: At baseline and 7 days post energy drink and placebo consumption
Max PR-interval After a Single Shot and After Chronic Consumption
Maximum PR-interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Measured: At baseline and 7 days post energy drink and placebo consumption
Max QRS Duration After a Single Shot and After Chronic Consumption
Max QRS duration measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Measured: At baseline and 7 days post energy drink and placebo consumption
Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
Max QT interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Measured: At baseline and 7 days post energy drink and placebo consumption
Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
Max QTc interval measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days
Measured: At baseline and 7 days post energy drink and placebo consumption

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2011Jul 2013

First posted6 Apr 2011 (estimated)
Study startApr 2011
Primary completionJul 2013
Study completionJul 2013

Why it stopped: Unable to recruit enough subjects

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Healthy VolunteersStudies 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: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01329679
Sponsor's protocol ID: FWH20110111H
Status last verified: Aug 2020
First submitted: 4 Apr 2011
Last updated: 9 Sep 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Healthy Volunteers trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Effects of Single and Multiple Energy Shots on Blood Pressure and Electrocardiographic Parameters: A Randomized, Double Blind, Crossover, Placebo-controlled Trial
ClinicalTrials.gov ID: NCT01329679
Acronym / sponsor ID: FWH20110111H
Conditions: Healthy Volunteers
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to recruit enough subjects
Enrolment: 26 participants (actual)
Lead sponsor: David Grant U.S. Air Force Medical CenterUS federal agency
Study start: Apr 2011 (actual)
Primary completion: Jul 2013 (actual)
Study completion: Jul 2013 (actual)
First posted: 6 Apr 2011 (estimated)
Results: Posted 10 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Energy Drink	Experimental	Dietary Supplement: Energy DrinkEnergy drink, 2 oz twice daily for 7 days
Placebo	Placebo comparator	Other: PlaceboWater, lime juice and cherry flavoring, 2 oz twice daily for 7 days

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (4 listed)

Healthy volunteers between ages 18-40 years
ONLY "as needed" use of ibuprofen or acetamenophen
Active duty military
DoD beneficiary or Civilian Government Employees

Key exclusion criteria (3 listed)

No other co-morbid conditions
No active prescription or OTC drug use
Not pregnant or planning to become pregnant during study participation

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 DrinkEnergy drink, 2oz twice daily for 7 days	Dietary supplement	Energy Drink
PlaceboAlso: Water, lime juice and cherry flavoringWater, lime juice and cherry flavoring	Other	Placebo

Primary outcome

Change in Office Systolic Blood Pressure
Time frame: At baseline and 7 days post energy drink and placebo consumption
SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.

6 secondary outcomes

Office DBP After a Single Energy Shot and After Chronic Consumption
Time frame: At baseline and 7 days post energy drink and placebo consumption
Max Heart Rate After a Single Shot and After Chronic Consumption
Time frame: At baseline and 7 days post energy drink and placebo consumption
Max PR-interval After a Single Shot and After Chronic Consumption
Time frame: At baseline and 7 days post energy drink and placebo consumption
Max QRS Duration After a Single Shot and After Chronic Consumption
Time frame: At baseline and 7 days post energy drink and placebo consumption
Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
Time frame: At baseline and 7 days post energy drink and placebo consumption
Max QTc Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7
Time frame: At baseline and 7 days post energy drink and placebo consumption

Results and safety

Results posted to the registry on 10 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Energy Drink, Then Placebo	13	13
Placebo, Then Energy Drink	13	13

Primary outcome: Change in Office Systolic Blood Pressure

Time frame: At baseline and 7 days post energy drink and placebo consumption. Mean (Standard Deviation). Unit: mmHg

Measure	Energy Drink n = 26	Placebo n = 26
SBP at baseline	128 (9.98)	123 (8.49)
SBP at Day 7	127 (9.88)	124 (8.29)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: During the study, for up to 7 days per intervention. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Energy Drink	0 of 26 (0%)	0 of 26 (0%)	Not reported
Placebo	0 of 26 (0%)	0 of 26 (0%)	Not reported

Limitations and caveats (from the sponsor): Small sample size and limited to 7 days of consumption.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Shah Sachin, Pharm.D. principal investigator

David Grant Medical Center

Questions about this trial

What is this clinical trial studying?

A study testing Energy Drink in people with Healthy Volunteers, run by David Grant U.S. Air Force Medical Center.

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 4 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 10 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Office Systolic Blood Pressure (time frame: At baseline and 7 days post energy drink and placebo consumption). 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 NCT01329679.

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 9 Sep 2020.