Electrical Alternation of HeartNCT02572102
Impact of Energy Drinks and Panax Ginseng on Heart Rhythm
A study testing Energy Drink and Panax Ginseng in people with Electrical Alternation of Heart and Blood Pressure, run by University of the Pacific.
Trial summary
To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Electrical Alternation of Heart, Blood Pressure
- What is being tested?
- Energy Drink and Panax Ginseng
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Mar 2016
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female adults 18-40 years old.
Who cannot join
- Baseline corrected QT (QTc) interval greater than 440 milliseconds,
- blood pressure at initial screening appointment greater than 140/90 mmHg,
- concurrent use of prescriptions or OTC medications taken on a daily basis,
- pregnant females,
- patients with any baseline ECG abnormalities.
About this study
Official title: Impact of Energy Drinks and Panax Ginseng on Heart Rhythm in Healthy Volunteers
To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.
Read the detailed description
Energy drinks are composed of a variety of ingredients such as caffeine, taurine, and panax ginseng amongst others. The safety and efficacy of these ingredients individually and in combination need further exploration. This study is designed to assess the electrocardiographic and blood pressure effects of energy drinks and panax ginseng in healthy volunteers.
- Conditions
- Electrical Alternation of Heart, Blood Pressure
- Being tested
- Energy Drink, Panax Ginseng, Placebo
- Keywords
- ECG, Blood Pressure, Energy Drinks, Panax Ginseng
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Energy DrinkDietary supplement
Energy Drink, two 16oz containers consumed in 45 minutes
Panax GinsengDietary supplement
Panax Ginseng, lime juice, water and cherry flavoring
PlaceboOther
Lime juice, water and cherry flavoring
| Study group | Role | What they receive |
|---|---|---|
| Energy Drink | Experimental | Two 16 ounce containers of an Energy Drink Receives: Dietary Supplement: Energy Drink |
| Panax Ginseng | Active comparator | 800 mg of Panax Ginseng in 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water Receives: Dietary Supplement: Panax Ginseng |
| Placebo | Placebo comparator | 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
QTc interval changes
Measured: 5.5 hours over 3 visits
Systolic blood pressure changes
Measured: 5.5 hours over 3 visits
Secondary outcomes (5)
QT interval changes
Measured: 5.5 hours over 3 visits
PR interval changes
Measured: 5.5 hours over 3 visits
QRS duration changes
Measured: 5.5 hours over 3 visits
Heart rate changes
Measured: 5.5 hours over 3 visits
Diastolic blood pressure changes
Measured: 5.5 hours over 3 visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2015 (estimated)
- Study startJun 2015
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical Alternation of HeartStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Pacific
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572102
- Sponsor's protocol ID
- 15-119
- Status last verified
- Oct 2015
- First submitted
- 6 Oct 2015
- Last updated
- 8 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Energy Drinks and Panax Ginseng on Heart Rhythm in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT02572102
- Acronym / sponsor ID
- 15-119
- Conditions
- Electrical Alternation of Heart, Blood Pressure
- Keywords
- ECG, Blood Pressure, Energy Drinks, Panax Ginseng
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of the PacificUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 8 Oct 2015 (estimated)
- 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.
To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.
Detailed description
Energy drinks are composed of a variety of ingredients such as caffeine, taurine, and panax ginseng amongst others. The safety and efficacy of these ingredients individually and in combination need further exploration. This study is designed to assess the electrocardiographic and blood pressure effects of energy drinks and panax ginseng in healthy volunteers.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Energy Drink | Experimental | Dietary Supplement: Energy DrinkTwo 16 ounce containers of an Energy Drink |
| Panax Ginseng | Active comparator | Dietary Supplement: Panax Ginseng800 mg of Panax Ginseng in 70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water |
| Placebo | Placebo comparator | Other: Placebo70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female adults 18-40 years old.
Key exclusion criteria (5 listed)
- Baseline corrected QT (QTc) interval greater than 440 milliseconds,
- blood pressure at initial screening appointment greater than 140/90 mmHg,
- concurrent use of prescriptions or OTC medications taken on a daily basis,
- pregnant females,
- patients with any baseline ECG abnormalities.
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, two 16oz containers consumed in 45 minutes | Dietary supplement | Energy Drink |
| Panax GinsengPanax Ginseng, lime juice, water and cherry flavoring | Dietary supplement | Panax Ginseng |
| PlaceboLime juice, water and cherry flavoring | Other | Placebo |
Primary outcome
QTc interval changes
Time frame: 5.5 hours over 3 visits
Systolic blood pressure changes
Time frame: 5.5 hours over 3 visits
5 secondary outcomes
QT interval changes
Time frame: 5.5 hours over 3 visits
PR interval changes
Time frame: 5.5 hours over 3 visits
QRS duration changes
Time frame: 5.5 hours over 3 visits
Heart rate changes
Time frame: 5.5 hours over 3 visits
Diastolic blood pressure changes
Time frame: 5.5 hours over 3 visits
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2015.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Energy Drink and Panax Ginseng in people with Electrical Alternation of Heart and Blood Pressure, run by University of the Pacific.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 8 Oct 2015. 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?
Results are not available in the source record.
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?
QTc interval changes (time frame: 5.5 hours over 3 visits). The study lists 2 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 8 Oct 2015.