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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495063
Recruitment Status : Withdrawn (Unable to quantify caffeine)
First Posted : April 11, 2018
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Elizabeth Tesch, David Grant U.S. Air Force Medical Center

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.

Condition or disease Intervention/treatment Phase
Cardiovascular Injury Dietary Supplement: Natural Caffeine Dietary Supplement: Synthetic Caffeine Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention 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 (Participant, Investigator)
Primary Purpose: Other
Official Title: Comparison of Synthetic and Natural Caffeine on Hemodynamic Parameters in Young, Healthy Volunteers: A Randomized, Double Blind, Crossover Study
Actual Study Start Date : September 16, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Caffeine

Arm Intervention/treatment
Experimental: Natural Caffeine
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
Consumption of 400mg of natural caffeine

Experimental: Synthetic Caffeine
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
Consumption of 400mg of synthetic caffeine




Primary Outcome Measures :
  1. Peripheral systolic blood pressure [ Time Frame: Four hours ]
    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.


Secondary Outcome Measures :
  1. Change in peripheral diastolic blood pressure [ Time Frame: Four hours ]
    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.

  2. Cardiac output [ Time Frame: Four hours ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03495063


Locations
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United States, California
David Grant Medical Center
Travis Air Force Base, California, United States, 94535
Sponsors and Collaborators
David Grant U.S. Air Force Medical Center
Investigators
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Principal Investigator: Elizabeth A Tesch David Grant Medical Center
Principal Investigator: Sachin A Shah David Grant Medical Center
Publications:
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Responsible Party: Elizabeth Tesch, PGY-1 Pharmacy Resident, David Grant U.S. Air Force Medical Center
ClinicalTrials.gov Identifier: NCT03495063    
Other Study ID Numbers: FDG20180007H
First Posted: April 11, 2018    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Caffeine
Central Nervous System Stimulants
Physiological Effects of Drugs
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents