Impact of Energy Drinks and Panax Ginseng on Heart Rhythm | NCT02572102

Studies
Impact of Energy Drinks and Panax Ginseng on Heart Rhythm

NCT02572102

Sponsor

University of the Pacific

Status

Unknown status

Last Update Posted

Oct 8, 2015Estimated

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Electrical Alternation of Heart
Blood Pressure

Interventions

Energy Drink
Panax Ginseng
Placebo

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2015

Primary Completion Date

Mar 2016Estimated

Completion Date

Mar 2016Estimated

First Submitted Date

Oct 6, 2015

First Submission Date that Met QC Criteria

Oct 7, 2015

First Posted Date

Oct 8, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2015

Last Update Posted Date

Oct 8, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Energy Drink	Dietary Supplement	Energy Drink, two 16oz containers consumed in 45 minutes	Energy Drink

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
QTc interval changes		5.5 hours over 3 visits
Systolic blood pressure changes		5.5 hours over 3 visits

Secondary Outcomes

Measure	Description	Time Frame
QT interval changes		5.5 hours over 3 visits
PR interval changes		5.5 hours over 3 visits
QRS duration changes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy male or female adults 18-40 years old.

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Type	Date	Date Unknown
Release	Sep 29, 2021
Reset	Oct 27, 2021

Submission Tracking

Estimated Results First Submitted Date

Sep 29, 2021

First MCP Posted Date

Not provided

Submission Infos

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Sep 29, 2021			Oct 27, 2021

Intervention Browse Module

MeSH Terms

ID	Term
D061215	Energy Drinks
C000713447	Asian ginseng

Ancestor Terms

ID	Term
D001628	Beverages
D000066888	Diet, Food, and Nutrition
D010829	Physiological Phenomena
D019602	Food and Beverages

Browse Leaves

Not provided

Browse Branches

Not provided