Impact of Energy Drinks on Cardiovascular Endpoints

David Grant U.S. Air Force Medical Center

Status: Terminated

Conditions: Healthy Volunteers

Treatments: Other: Placebo; Dietary Supplement: Energy Drink

Study type: Interventional

Funder types: Other U.S. Federal agency

Identifiers

NCT01329679

FWH20110111H

Details and patient eligibility

About

Objective: To assess the cardiac effects of a an energy drink on blood pressure and heart rhythm in healthy subjects.

Study design: Double blind, placebo controlled, cross-over

Study population: Healthy human volunteers (active-duty) between age 18 to 40 years with no other medical conditions.

Intervention: Energy drink or Placebo

Primary outcome: Change in office systolic blood pressure

Enrollment: 26 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy volunteers between ages 18-40 years
• ONLY "as needed" use of ibuprofen or acetamenophen
• Active duty military
• DoD beneficiary or Civilian Government Employees

Exclusion criteria

• No other co-morbid conditions
• No active prescription or OTC drug use
• Not pregnant or planning to become pregnant during study participation

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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26 participants in 2 patient groups, including a placebo group

Energy Drink

Experimental group

Description:

Energy drink, 2 oz twice daily for 7 days

Treatment:

Dietary Supplement: Energy Drink

Placebo

Placebo Comparator group

Description:

Water, lime juice and cherry flavoring, 2 oz twice daily for 7 days

Treatment:

Other: Placebo