Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers

NCT03495063 | Withdrawn

• 1 other identifier: FDG20180007H
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study determine the difference in hemodynamic effects of synthetic and natural caffeine consumption in healthy individuals through blood pressure (central and peripheral) assessment. Participants will randomly be assigned to consume either one 8oz cup of coffee containing 400mg of caffeine (increased caffeine using concentrated coffee) or one 8oz cup of coffee-flavored drink with approximately 400mg synthetic caffeine from capsules dissolved in it.

Conditions

Cardiovascular Injury

Outcome Measures

Primary Outcomes (1)

• Peripheral systolic blood pressure

  Two peripheral systolic blood pressure measurements will be taken prior to the consumption of the assigned study drink. Repeated peripheral systolic blood pressure readings will occur twice at each time point hourly for a period of four hours. For each measurement, participant will be asked to rest for five minutes.

  Four hours

Secondary Outcomes (2)

• Change in peripheral diastolic blood pressure

  Four hours

• Cardiac output

  Four hours

Study Arms (2)

Natural Caffeine

EXPERIMENTAL

Subjects will be their own control and will have repeated measures after the consumption of a drink with 400mg of natural caffeine. Blood pressure measurements will be taken at baseline, then hourly for four hours.

Dietary Supplement: Natural Caffeine

Synthetic Caffeine

EXPERIMENTAL

Subjects will be their own control and will have repeated measures after the consumption of a drink with 400mg of synthetic caffeine. Blood pressure measurements will be taken at baseline, then hourly for four hours.

Dietary Supplement: Synthetic Caffeine

Interventions

Natural Caffeine DIETARY_SUPPLEMENT

Consumption of 400mg of natural caffeine

Natural Caffeine

Synthetic Caffeine DIETARY_SUPPLEMENT

Consumption of 400mg of synthetic caffeine

Synthetic Caffeine

Eligibility Criteria

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

You may qualify if:

• Healthy males and females
• Active duty military service members
• DoD beneficiaries
• Participants must be willing to refrain from caffeine use 72 hours prior to study days one and five

You may not qualify if:

• Cardiovascular risk factors: Heart rhythm other than normal sinus, history of atrial or ventricular arrhythmia, family history of premature sudden cardiac death before the age of 60, left ventricular hypertrophy, acute myocardial ischemia, atherosclerosis, hypertension, and palpitations. This will be determined through the questionnaire responses of the participant and thorough chart review.
• Blood pressure at initial screening appointment or at baseline on study Day One greater than 130/80 and if 130-139/80-89, FRS risk greater than 10%.
• Presence of any known medical condition, confirmed through participant interview up to the discretion of the research team. Examples of these are:
• Hypertension
• Thyroid disease
• Type 1 or 2 Diabetes Mellitus
• Recurrent headaches
• Any psychiatric condition or neurological disorder including seizures
• History of alcohol or drug abuse in the previous five years
• Ever been diagnosed or told they have or had renal or hepatic dysfunction
• Tobacco use
• Concurrent use of any medication taken in an amount greater than twice a week, to include herbal products or supplements, not to include hormonal contraceptives. If less than or equal to two days per week, the investigator will determine if the subject is to be included or excluded based on the available literature for that medication.
• Pregnant or lactating females will be excluded from participation with urine dipstick tests used to rule out pregnancy (pregnancy test performed before each treatment session, days one, five)
• All non-English speaking/writing subjects and those that do not understand the study or consent process will be excluded from the study due to unavailability of medical qualified translator at all times during the study.
• If the subject refuses to sign the informed consent document or HIPAA Authorization, they will be excluded as well.

Sponsors & Collaborators

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

Study Sites (1)

David Grant Medical Center

Travis Air Force Base, California, 94535, United States

Location

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: 28446495 BACKGROUND

• Furie B, Furie BC. Mechanisms of thrombus formation. N Engl J Med. 2008 Aug 28;359(9):938-49. doi: 10.1056/NEJMra0801082. No abstract available.

  PMID: 18753650 BACKGROUND

• Guessous I, Eap CB, Bochud M. Blood pressure in relation to coffee and caffeine consumption. Curr Hypertens Rep. 2014 Sep;16(9):468. doi: 10.1007/s11906-014-0468-2.

  PMID: 25090963 BACKGROUND

• Hartley TR, Lovallo WR, Whitsett TL. Cardiovascular effects of caffeine in men and women. Am J Cardiol. 2004 Apr 15;93(8):1022-6. doi: 10.1016/j.amjcard.2003.12.057.

  PMID: 15081447 BACKGROUND

• Knapik JJ, Trone DW, McGraw S, Steelman RA, Austin KG, Lieberman HR. Caffeine Use among Active Duty Navy and Marine Corps Personnel. Nutrients. 2016 Oct 9;8(10):620. doi: 10.3390/nu8100620.

  PMID: 27735834 BACKGROUND

• Lieberman HR, Stavinoha T, McGraw S, White A, Hadden L, Marriott BP. Caffeine use among active duty US Army soldiers. J Acad Nutr Diet. 2012 Jun;112(6):902-12, 912.e1-4. doi: 10.1016/j.jand.2012.02.001.

  PMID: 22709816 BACKGROUND

• Marik PE. Noninvasive cardiac output monitors: a state-of the-art review. J Cardiothorac Vasc Anesth. 2013 Feb;27(1):121-34. doi: 10.1053/j.jvca.2012.03.022. Epub 2012 May 19. No abstract available.

  PMID: 22609340 BACKGROUND

Study Officials

• Elizabeth A Tesch

  David Grant Medical Center

  PRINCIPAL INVESTIGATOR

• Sachin A Shah

  David Grant Medical Center

  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: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PGY-1 Pharmacy Resident

Model Details: This protocol uses a crossover design. The subject sample is randomized. Subjects will serve as their own controls as they will be asked to intake both the natural and synthetic caffeine at two different occasions.

Study Record Dates

• First Submitted: April 4, 2018
• First Posted: April 11, 2018
• Study Start: September 16, 2019
• Primary Completion: November 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 2, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)