Impact of Energy Drinks on Cardiovascular Endpoints

NCT01329679 | Terminated Results

• 1 other identifier: FWH20110111H
• Study Type: interventional
• Target: 26
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Change in Office Systolic Blood Pressure

  SBP = Systolic Blood Pressure measured at baseline (after a single energy shot or placebo consumption) and after chronic consumption for 7 days.

  At baseline and 7 days post energy drink and placebo consumption

Secondary Outcomes (6)

• Office DBP After a Single Energy Shot and After Chronic Consumption

  At baseline and 7 days post energy drink and placebo consumption

• Max Heart Rate After a Single Shot and After Chronic Consumption

  At baseline and 7 days post energy drink and placebo consumption

• Max PR-interval After a Single Shot and After Chronic Consumption

  At baseline and 7 days post energy drink and placebo consumption

• Max QRS Duration After a Single Shot and After Chronic Consumption

  At baseline and 7 days post energy drink and placebo consumption

• Max QT Interval After a Single Energy Shot or Placebo Consumption After Day 1 and After Chronic Consumption After Day 7

  At baseline and 7 days post energy drink and placebo consumption

Study Arms (2)

Energy Drink

EXPERIMENTAL

Energy drink, 2 oz twice daily for 7 days

Dietary Supplement: Energy Drink

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

Energy Drink DIETARY_SUPPLEMENT

Energy drink, 2oz twice daily for 7 days

Energy Drink

Placebo OTHER

Water, lime juice and cherry flavoring

Also known as: Water, lime juice and cherry flavoring

Placebo

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• David Grant U.S. Air Force Medical Center: lead

MeSH Terms

Interventions

Energy Drinks; Water

Intervention Hierarchy (Ancestors)

Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Limitations and Caveats

Small sample size and limited to 7 days of consumption.

Results Point of Contact

• Title: Sachin Shah
• Organization: DavidGrant

sshah@pacific.edu

707-423-3277

Study Officials

• Shah Sachin, Pharm.D.

  David Grant Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pharmacy Practice

Study Record Dates

• First Submitted: April 4, 2011
• First Posted: April 6, 2011
• Study Start: April 1, 2011
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 9, 2020
• Results First Posted: January 10, 2017

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share