Cardiovascular Effects of Energy Drinks in Healthy Adults
1 other identifier
interventional
25
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2013
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
September 9, 2013
CompletedFirst Posted
Study publicly available on registry
September 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 30, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
November 30, 2013
CompletedMay 18, 2022
May 1, 2022
5 months
September 9, 2013
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
EXPERIMENTALParticipants will receive an energy drink at the first study visit, and a placebo drink at the second study visit.
Placebo drink first, then energy drink
EXPERIMENTALParticipants will receive a placebo drink at the first study visit and an Energy Drink at the second study visit.
Interventions
Eligibility Criteria
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
- Mayo Cliniclead
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
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.
PMID: 26547226RESULT
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Svatikova, M.D., Ph.D.
Mayo Clinic
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