Effects of Caffeine on Cerebral Blood Flow

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2021-06-01

Brief Summary

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The goal of this clinical trial is to evaluate in clinically healthy young people if:

* after caffeine ingestion, there are variations in blood velocity of the middle cerebral arteries (VMCA),
* this variation is dependent on the administered dose.

Transcranial Doppler ultrasonography was used to record blood VMCA in three groups of 15 clinically healthy young adults each - no caffeine, low caffeine (45 mg) and high caffeine group (120 mg). Transcranial Doppler ultrasonography provided simultaneous bilateral VMCA measurements while subjects performed functional tests (hyperventilation and hypoventilation orders) and three cognitive activities (Test 1, short-term remembering, Test 2, solving a vocabulary problem, and Test 3, solving a math problem) each in 31-second tests with 1-minute rest between them. Participants were assessed before and 30 minutes after caffeine ingestion.

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Detailed Description

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Were used in the study, Capsules dosed with 45mg and 120 mg of anhydrous caffeine and flour capsules as a placebo. In the preparation of the capsules, a semi-automatic capsulator No. 0 (Capsunorm® by Tecnyfarma®) were used, colorless hard gelatin capsules No. 0 by Acopharma® and anhydrous caffeine (Biochem®, C.A.S. 58-08-2).

Viasys Sonara transcranial Doppler unit and a 2 MHz probe were used to sample the middle cerebral artery at depths of 60 millimeters, using emission doppler pulsed performing spectral analysis in real time. Two probes (bilaterally) of 2MHz were placed at a depth between 55 and 60 mm, thus making it possible to analyse both middle cerebral arteries simultaneously.

Each participant was asked not to ingest caffeine and exercise vigorously for at least 12 hours before the assessment. In the case of smokers, they were also asked not to smoke for at least 2 hours before the evaluation. The laboratory had medium luminosity, silent and controlled temperature (23º/24ºC). To avoid inter-observer errors, all examinations were performed by the same investigator who was not aware of what dose was/had been administered to the participant.

Subjects were tested while seated in a reclining chair located in a dimly lit, sound-attenuated room and performed the activities with their eyes closed.

Conditions

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Cardiovascular System

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

All subjects were submitted to 2 evaluation moments: the first baseline moment and the second moment, 30 minutes after caffeine ingestion, which constitutes the time required for caffeine absorption.

In each of the 2 moments, they performed 30 seconds of continuous breathing (hypoventilation), followed by 30 seconds of continuous rapid breathing (hyperventilation). VMCA measurements were stabilized between these tests. The study started with apnea testing because VMCA requires less time to return to baseline levels after hypoventilation than after hyperventilation.

When VMCA measurements were stable, a 30-second baseline period was followed by three 30-second cognitive tasks, with a 1-minute break between activities: short-term memory test; solve a vocabulary problem; and solving a math problem. Three versions of each cognitive task were used for the three conditions. The procedure was completed with a final rest period of 60 seconds.

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Three groups were randomly constituted, with 15 young people each: control group without caffeine, group with relatively small amount of caffeine (45 mg) administered and group with greater amount of caffeine (120 mg). Participants were not aware to which group they belong.

Study Groups

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No caffeine

The control group took flour capsules.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Flour capsules as a placebo.

Low caffeine

Group with relatively small amount of caffeine (45 mg) administered.

Group Type EXPERIMENTAL

Anhydrous caffeine (45mg)

Intervention Type OTHER

Capsules dosed with 45mg of anhydrous caffeine.

High caffeine

Group with greater amount of caffeine (120 mg) administered.

Group Type EXPERIMENTAL

Anhydrous caffeine (120mg)

Intervention Type OTHER

Capsules dosed with 120mg of anhydrous caffeine.

Interventions

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Placebo

Flour capsules as a placebo.

Intervention Type OTHER

Anhydrous caffeine (45mg)

Capsules dosed with 45mg of anhydrous caffeine.

Intervention Type OTHER

Anhydrous caffeine (120mg)

Capsules dosed with 120mg of anhydrous caffeine.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* clinically healthy young people

Exclusion Criteria

* Individuals with hypertension, high cholesterol, diabetes, arrhythmias, carotid sinus syndrome, severe carotid stenosis and who were in an unstable clinical situation.

Minimum Eligible Age

18 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes