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Cardiovascular InjuryNCT03495063

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

A study testing Natural Caffeine and Synthetic Caffeine in people with Cardiovascular Injury, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for
Cardiovascular Injury
What is being tested?
Natural Caffeine and Synthetic Caffeine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
16 Sep 2019to 1 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 17Show fewer
  • 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.
  • Allergy to any substance in the study design.
  • Any other medical reason that at the discretion of the investigators would pose a risk to the health of the subject.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • David Grant Medical Center

    Travis Air Force Base, California, 94535

Other trials in United States

About this study

Official title: Comparison of Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers: A Randomized, Double Blind, Crossover Study

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.

Read the detailed description

The purpose of this study is to assess the difference in effects of consuming synthetic versus natural caffeine on hemodynamic parameters in healthy subjects. This study will determine the difference in hemodynamic effects of synthetic and natural caffeine consumption in healthy individuals through blood pressure (central and peripheral) assessment. The participants in this study are healthy adults who will be introduced to a risk that may be more than they would encounter through their normal daily activities. This study seeks to add to the literature by evaluating the difference in impact of synthetic compared to natural caffeine on central blood pressure.

This protocol has the following aims:

  1. Investigators hypothesize there will be a (baseline adjusted [ΔBP]) difference in BP (peripheral and central) between the natural and synthetic caffeine arms in healthy volunteers post consumption.
  2. Investigators hypothesize there will be (baseline adjusted [ΔCO]) no difference in CO between the natural and synthetic caffeine arms in healthy volunteers post consumption.
  3. Investigators hypothesize there will be (baseline adjusted [ΔSVR]) no difference in SVR between the natural and synthetic caffeine arms in healthy volunteers hours post consumption.
Being tested
Natural Caffeine, Synthetic Caffeine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Natural CaffeineDietary supplement

    Consumption of 400mg of natural caffeine

  • Synthetic CaffeineDietary supplement

    Consumption of 400mg of synthetic caffeine

Study groups in NCT03495063
Study groupRoleWhat they receive
Natural CaffeineExperimentalSubjects 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.
Receives: Dietary Supplement: Natural Caffeine
Synthetic CaffeineExperimentalSubjects 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.
Receives: Dietary Supplement: Synthetic Caffeine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Four hours

Secondary outcomes (2)

  1. Change in peripheral diastolic blood pressure

    Two peripheral diastolic blood pressure measurements will be taken prior to the consumption of the assigned study drink. Repeated peripheral diastolic 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.

    Measured: Four hours

  2. Cardiac output

    Cardiac output will be measured prior to the consumption of assigned study drink. Repeated cardiac output 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.

    Measured: Four hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2018
  2. Study start16 Sep 2019
  3. Primary completion1 Nov 2020 (estimated)
  4. Study completion1 Dec 2020 (estimated)

Why it stopped: Unable to quantify caffeine

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
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.
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03495063
Sponsor's protocol ID
FDG20180007H
Status last verified
Mar 2020
First submitted
4 Apr 2018
Last updated
2 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28446495

  • 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.

    PubMed 18753650

  • 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.

    PubMed 25090963

  • 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.

    PubMed 15081447

  • 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.

    PubMed 27735834

  • 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.

    PubMed 22709816

  • 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.

    PubMed 22609340

Questions about this trial

What is this clinical trial studying?

A study testing Natural Caffeine and Synthetic Caffeine in people with Cardiovascular Injury, run by David Grant U.S. Air Force Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 2 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral systolic blood pressure (time frame: Four hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03495063, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Apr 2020; AzTrials last refreshed its copy on 7 Nov 2026.

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