NCT04149717

Brief Summary

  1. 1.Statement of the research question:
  2. 2.Purpose and significance of the study:

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

October 31, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2023

Completed
Last Updated

March 23, 2021

Status Verified

May 1, 2020

Enrollment Period

2.9 years

First QC Date

October 31, 2019

Last Update Submit

March 19, 2021

Conditions

Cardiac ArrhythmiaBlood Pressure

Keywords

caffeinetaurinecarnitineenergy drink

Outcome Measures

Primary Outcomes (1)

  • Change in QTc interval of EKG

    Lengthening or shortening of the corrected QT interval (QTc) of the subject EKG at 1, 2, and 4 hours post treatment will be compared to pre-treatment measurements. The QTc will be calculated utilizing Bezett's formula.

    0, 1, 2, 4, hours post-dose

Secondary Outcomes (2)

  • Change in Heart Rate

    0, 1, 2, 4, hours post-dose

  • Change in Systolic and Diastolic Blood Pressure

    0, 1, 2, 4, hours post-dose

Study Arms (4)

Changes in BP, HR and EKG with Test Solution A and Exercise

EXPERIMENTAL

1. Subject baseline HR, BP, EKG recorded. 2. Subject will ingest sucrose (150g): 3. 30 min later, subject will exercise on a treadmill 4. Subjects will return each week to repeat the above procedures with a different test solution.

Dietary Supplement: Energy Drink Ingredients and Exercise

Changes in BP, HR and EKG with Test Solution B and Exercise

EXPERIMENTAL

1. Subject baseline HR, BP, ECG recorded. 2. Subject will ingest sucrose (150g); caffeine (400 mg) 3. 30 min later, subject will exercise on a treadmill 4. Subjects will return each week to repeat the above procedures with a different test solution.

Dietary Supplement: Energy Drink Ingredients and Exercise

Changes in BP, HR and EKG with Test Solution C and Exercise

EXPERIMENTAL

1. Subject baseline HR, BP, ECG recorded. 2. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg) 3. 30 min later, subject will exercise on a treadmill

Dietary Supplement: Energy Drink Ingredients and Exercise

Changes in BP, HR and EKG with Test Solution C

EXPERIMENTAL

1. Subject baseline HR, BP, ECG recorded. 2. Subject will ingest sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg)

Dietary Supplement: Energy Drink Ingredients and Exercise

Interventions

Energy Drink Ingredients and ExerciseDIETARY_SUPPLEMENT

Subject will ingest 500 mL of one of three test solutions: A) sucrose (150g) B) sucrose (150g); caffeine (400 mg) C) sucrose (150g); caffeine (400 mg); taurine (4,000 mg); carnitine (400 mg) 3. 30 min later, subject will exercise on a treadmill using the Bruce Protocol maximum exercise test (https://www.aopa.org/go-fly/medical-resources/health-conditions/heart-and-circulatory-system/bru...). For one additional session, subjects will receive test solution C without exercise. 4\. Each stage will last 3 minutes. Stage 1 = 1.7 mph at 2% Grade Stage 2 = 2.5 mph at 4% Grade Stage 3 = 3.4 mph at 6% Grade Stage 4 = 4.2 mph at 8% Grade Stage 5 = 5.0 mph at 10% Grade Stage 6 = 5.5 mph at 12% Grade Stage 7 = 6.0 mph at 14% Grade Stage 8 = 6.5 mph at 15% Grade Stage 9 = 7.0 mph at 15% Grade. The test will end when subjects reach exhaustion. 5\. 1, 2, and 4 hrs following ingestion, HR, BP, and EKG will be recorded.

Changes in BP, HR and EKG with Test Solution A and ExerciseChanges in BP, HR and EKG with Test Solution B and ExerciseChanges in BP, HR and EKG with Test Solution CChanges in BP, HR and EKG with Test Solution C and Exercise

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • No preexisting medical conditions (including pregnancy)
  • Subjects must be capable of exercising on a treadmill (Vigorous activity: more than 7 kcal/min; https://www.cdc.gov/nccdphp/dnpa/physical/pdf/PA\_Intensity\_table\_2\_1.pdf)
  • BMI within normal range (18.5 - 24.9 kg/m2)
  • Average daily caffeine intake between 1 and 5 caffeinated beverages

You may not qualify if:

  • Age below 18 or greater than 39 years
  • Unable to provide legal consent to participate in the study
  • Preexisting medical conditions including but not limited to: pregnancy, cardiovascular disease, endocrine disorders, psychiatric or neurological disorders, musculo-skeletal disorders, immune disorders, respiratory disorders, dermatological disorders, infections, blindness, hearing disabilities
  • BMI less than 18.5 or greater than 24.9 kg/m25.
  • Current or future students of Drs. Johnson and/or Montepara
  • Incarceration in local, state or federal justice systems

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Duquesne University

Pittsburgh, Pennsylvania, 15282, United States

RECRUITING

Related Publications (7)

  • Fletcher EA, Lacey CS, Aaron M, Kolasa M, Occiano A, Shah SA. Randomized Controlled Trial of High-Volume Energy Drink Versus Caffeine Consumption on ECG and Hemodynamic Parameters. J Am Heart Assoc. 2017 Apr 26;6(5):e004448. doi: 10.1161/JAHA.116.004448.

    PMID: 28446495BACKGROUND

  • Kozik TM, Shah S, Bhattacharyya M, Franklin TT, Connolly TF, Chien W, Charos GS, Pelter MM. Cardiovascular responses to energy drinks in a healthy population: The C-energy study. Am J Emerg Med. 2016 Jul;34(7):1205-9. doi: 10.1016/j.ajem.2016.02.068. Epub 2016 Mar 2.

    PMID: 27162113BACKGROUND

  • Goldfarb M, Tellier C, Thanassoulis G. Review of published cases of adverse cardiovascular events after ingestion of energy drinks. Am J Cardiol. 2014 Jan 1;113(1):168-72. doi: 10.1016/j.amjcard.2013.08.058. Epub 2013 Oct 4.

    PMID: 24176062BACKGROUND

  • Shah SA, Szeto AH, Farewell R, Shek A, Fan D, Quach KN, Bhattacharyya M, Elmiari J, Chan W, O'Dell K, Nguyen N, McGaughey TJ, Nasir JM, Kaul S. Impact of High Volume Energy Drink Consumption on Electrocardiographic and Blood Pressure Parameters: A Randomized Trial. J Am Heart Assoc. 2019 Jun 4;8(11):e011318. doi: 10.1161/JAHA.118.011318. Epub 2019 May 29.

    PMID: 31137991BACKGROUND

  • Longo N, Frigeni M, Pasquali M. Carnitine transport and fatty acid oxidation. Biochim Biophys Acta. 2016 Oct;1863(10):2422-35. doi: 10.1016/j.bbamcr.2016.01.023. Epub 2016 Jan 29.

    PMID: 26828774BACKGROUND

  • Turnbull D, Rodricks JV, Mariano GF, Chowdhury F. Caffeine and cardiovascular health. Regul Toxicol Pharmacol. 2017 Oct;89:165-185. doi: 10.1016/j.yrtph.2017.07.025. Epub 2017 Jul 26.

    PMID: 28756014BACKGROUND

  • Satoh H. Cardiac actions of taurine as a modulator of the ion channels. Adv Exp Med Biol. 1998;442:121-8. doi: 10.1007/978-1-4899-0117-0_16.

    PMID: 9635023BACKGROUND

Related Links

MeSH Terms

Conditions

Arrhythmias, Cardiac

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • David Delmonico, Ph.D.

    Institutional Review Board, Chair, Duquesne University

    STUDY CHAIR

Central Study Contacts

David A Johnson, Ph.D.

CONTACT

412-396-5952johnsond@duq.edu

Courtney Montepara, Pharm.D.

CONTACT

412-396-4335monteparac@duq.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The three test solutions will be coded as "A", "B" and "C". Both the subject and the provider of the test solution to the subject will be blinded to the ingredients in the solution. The person who provides the test solution will be blind to the identity of the subject other than by subject number. The person who analyzes the data will be blinded to subject identity and which test solution was administered. The key for the test solutions and subject identity will be kept in a locked drawer in the office of the principal investigator.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: repeated measures, crossover design
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 31, 2019

First Posted

November 4, 2019

Study Start

January 1, 2020

Primary Completion

December 1, 2022

Study Completion

March 1, 2023

Last Updated

March 23, 2021

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)