NCT01940822

Brief Summary

This study is being done to look at the cardiovascular response, if any, to intake of commercially available energy drink. We hypothesize that energy drink consumption compared to a control drink in healthy adults alters the cardiovascular hemodynamic system.The focus of this study is to elucidate the physiological/cardiovascular response to an energy drink consumption as compared to a control drink both at rest and during stressful conditions in healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

July 1, 2013

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

September 9, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 12, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2013

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

September 9, 2013

Last Update Submit

May 17, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change in blood pressure

    Baseline, 30 minutes after consumption

Secondary Outcomes (2)

  • Change in heart rate

    Baseline, 30 minutes after consumption

  • Change in Plasma Norepinephrine

    Baseline, 30 minutes after consumption

Study Arms (2)

Energy drink first, then placebo drink

EXPERIMENTAL

Participants will receive an energy drink at the first study visit, and a placebo drink at the second study visit.

Other: Energy DrinkOther: Placebo Drink

Placebo drink first, then energy drink

EXPERIMENTAL

Participants will receive a placebo drink at the first study visit and an Energy Drink at the second study visit.

Other: Energy DrinkOther: Placebo Drink

Interventions

Energy drink first, then placebo drinkPlacebo drink first, then energy drink
Energy drink first, then placebo drinkPlacebo drink first, then energy drink

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Subjects with known cardiovascular and/or thyroid disease
  • Subjects currently taking medications other than oral contraceptive pill
  • Smokers
  • Prior history of caffeine sensitivity or allergy
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • Svatikova A, Covassin N, Somers KR, Somers KV, Soucek F, Kara T, Bukartyk J. A Randomized Trial of Cardiovascular Responses to Energy Drink Consumption in Healthy Adults. JAMA. 2015 Nov 17;314(19):2079-82. doi: 10.1001/jama.2015.13744. No abstract available.

Related Links

MeSH Terms

Interventions

Energy Drinks

Intervention Hierarchy (Ancestors)

BeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Anna Svatikova, M.D., Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Medicine

Study Record Dates

First Submitted

September 9, 2013

First Posted

September 12, 2013

Study Start

July 1, 2013

Primary Completion

November 30, 2013

Study Completion

November 30, 2013

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations