NCT02572102

Brief Summary

To assess the cardiac effects of an energy drink and Panax Ginseng in healthy volunteers.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 6, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 8, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

9 months

First QC Date

October 6, 2015

Last Update Submit

October 7, 2015

Conditions

Electrical Alternation of HeartBlood Pressure

Keywords

ECGBlood PressureEnergy DrinksPanax Ginseng

Outcome Measures

Primary Outcomes (2)

  • QTc interval changes

    5.5 hours over 3 visits

  • Systolic blood pressure changes

    5.5 hours over 3 visits

Secondary Outcomes (5)

  • QT interval changes

    5.5 hours over 3 visits

  • PR interval changes

    5.5 hours over 3 visits

  • QRS duration changes

    5.5 hours over 3 visits

  • Heart rate changes

    5.5 hours over 3 visits

  • Diastolic blood pressure changes

    5.5 hours over 3 visits

Study Arms (3)

Energy Drink

EXPERIMENTAL

Two 16 ounce containers of an Energy Drink

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

Dietary Supplement: Panax Ginseng

Placebo

PLACEBO COMPARATOR

70 mL of cherry syrup, 20 mL of lime juice, 410 mL of carbonated water

Other: Placebo

Interventions

Energy DrinkDIETARY_SUPPLEMENT

Energy Drink, two 16oz containers consumed in 45 minutes

Energy Drink
Panax GinsengDIETARY_SUPPLEMENT

Panax Ginseng, lime juice, water and cherry flavoring

Panax Ginseng
PlaceboOTHER

Lime juice, water and cherry flavoring

Placebo

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male or female adults 18-40 years old.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Energy DrinksAsian ginseng

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2015

First Posted

October 8, 2015

Study Start

June 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 8, 2015

Record last verified: 2015-10