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Post-Exercise HypotensionNCT02335840

Doses of Coffee and Blood Pressure Response Post-exercise

A study testing CAF-1, CAF-2 and CAF-3 in people with Post-Exercise Hypotension and Hypertension, run by Federal University of Paraíba.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Introduction: reduction of blood pressure after physical exercise is called post exercise hypotension (PEH). However, previous studies demonstrate that ingestion of caffeine equivalent to three tea-cup of coffee abolishes this phenomenon. Objective: evaluate the influence of different doses of coffee in PEH. Read more about this study

Who is it for?
Ages 40 to 55 years
Conditions the study is for
Post-Exercise Hypotension, Hypertension
What is being tested?
CAF-1, CAF-2 and CAF-3
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
No sites listed yet
Study dates
Mar 2011to Nov 2014
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 40 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Were included subjects of both gender (three men), 40 to 55 years old, overweight and practitioners of aerobic exercise (walk) at least three months. They were treated with anti-hypertensive medication of class beta-adrenergic receptor blockers, thiazides and enzyme convertor of angiotensin inhibitors, and showing systolic and diastolic values controlled and habituated to coffee consumption.

Who cannot join

  • Would be excluded from the study volunteers who presented migraine or other withdrawal symptoms due to a washout to be carried out for coffee and other caffeinated foods.

About this study

Official title: Influence of Different Doses of Coffee in the Blood Pressure Response Post-exercise

Introduction: reduction of blood pressure after physical exercise is called post exercise hypotension (PEH). However, previous studies demonstrate that ingestion of caffeine equivalent to three tea-cup of coffee abolishes this phenomenon. Objective: evaluate the influence of different doses of coffee in PEH. Methods: eleven hypertensive performed four experimental sessions of aerobic exercise in cycle ergometer (40 minutes of duration, intensity between 60% and 80% of maximum heart rate) succeeds for the ingestion of one (CAF-1), two (CAF-2), three (CAF-3) doses of caffeinated coffee (144 mg/dose), or three doses of decaffeinated coffee (DESC). Blood pressure was measured in rest and during 120 minutes of recovery post exercise, each 10 minutes.

Read the detailed description

Volunteers: participated 12 volunteers diagnosed as hypertensive, both gender (three men), 40 to 55 years old, overweight and practitioners of aerobic exercise (walk) at least three months. They were treated with anti-hypertensive medication of class beta-adrenergic receptor blockers, thiazides and enzyme convertor of angiotensin inhibitors, and showing systolic and diastolic pressoric values controlled and habituated to coffee consumption. Would be excluded from the study volunteers who presented migraine or other withdrawal symptoms due to a washout to be carried out for coffee and other caffeinated foods. The volunteers participated of this study for average one month. This study was previously approved by Ethic Committee in Search with Humans at Hospital Lauro Wanderley, at Federal University of Paraiba, under protocol 21/2011. All volunteers was previously clarified about the experimental procedures, and they signed the written informed consent according resolution 466/12 at Health National Council (Brazil).

Design of Study: the study was experimental, randomized and double-blind. Before the experimental sessions the volunteers were instructed to avoid caffeinated foods during 48 hours. They performed four experimental sessions with the practice of aerobic exercise, succeed for the ingestion of caffeinated or decaffeinated coffee, according to following protocols: 1) one dose of 150 ml of coffee (144 mg of caffeine) ingested 10 minutes post-exercise (CAF-1); 2- two doses of 150 ml of coffee (2x144 mg of caffeine) ingested 10 and 20 minutes post-exercise (CAF-2); three doses of 150ml of coffee (3x 144 mg of caffeine) ingested 10, 20 and 30 minutes post-exercise (CAF-3); 4- three doses of 150 ml of decaffeinated coffee (108 mg of caffeine) ingested 10, 20 and 30 minutes post-exercise (DESC). The order of realization experimental sessions was determined randomly through the site www.randomizer.org. They remained seated during 120 minutes after exercise. Blood pressure was evaluated in rest, and during 120 minutes of post-exercise recovery, each 10 minutes.

Preparation and Ingestion of coffee: was utilized one caffeinated and decaffeinated coffee (São Braz, Cabedelo, Brazil) with one same serial number. Caffeinated and decaffeinated coffee had 1,2% and 0,3% of caffeine, respectively, in your composition. The method adopted to the preparation of caffeinated or decaffeinated coffee was previously utilized for Nóbrega et al. (15). Were prepared with addition of 40g coffee powder to each 500 ml of heated water during five minutes, limited by beginning of boil. Thus, the volume of 500 ml of coffee had one concentration of 480 mg of caffeine. Considering each tea-cup ingested had one volume of 150 ml, so one, two and three tea-cups with coffee had respectively 144 mg, 288 mg and 432 mg of caffeine. Three tea-cups of decaffeinated coffee were 108 mg of caffeine. The doses of caffeinated or decaffeinated coffee were sweetened with sugar (Alegre, Mamanguape, Brazil). The coffee was strained with filters paper (Mellita®, Minden, Alemanha). To ensure the accuracy of volume intake by volunteers at all time was utilized one dosing tea-cup previously calibrated to volume of one tea-cup (150 ml). The intake coffee was performed on first 30 minutes of period recovery, each 10 minutes. During moment of ingestion, volunteers stay seated and was stipulated a deadline of five minutes to intake the coffee.

Protocol of Physical Exercise: volunteers performed four experimental sessions with aerobic exercise on a stationary bicycle (Perform V3, Movement®, Pompeia, Sao Paulo), lasting 40 minutes, intensity between 60 and 80% of maximum heart rate (MHR). To estimate of MHR was utilized the equation proposed by Bruce et al. (16). To the prescription of target zone for exercise was adopted the protocol proposed by Karvonen et al. (17). The heart rate of rest and during the exercise was evaluated utilizing by cardiofrequencymeter (RS800CX, Polar Electro® Oy, Kempele, Finland)

Measures of Blood Pressure: after the volunteers arrived on laboratory, they were oriented to stay in rest seated during 10 minutes to measures of blood pressure on end of this period. Others measures were realized during the 120 minutes of post-exercise recovery, each 10minutes. The first 30 minutes of post-exercise recovery the measures were always performed one minute before coffee administration. The blood pressure was measured by auscultatory method, following the protocol proposed by VI Brazilian Guidelines of Arterial Hypertension (18). For this, was utilized one sphygmomanometer (Missouri, Embu, Brasil), previously calibrated against one mercury column and one stethoscope (Missouri, Embu, Brasil).

Statistical Analysis: all the data are presented as mean±standard-error of mean. All variables were tested for normal distribution using Shapiro-Wilk and Levene tests. For the comparisons of age, body mass index, heart rate of rest, systolic and diastolic blood pressure of rest between the experimental sessions was utilized one-way ANOVA. For the comparisons of systolic and diastolic post-exercise between the experimental sessions of study was realized two-way ANOVA plus Bonferroni test post hoc. P value small than 0,05 was considered statically significant.

Being tested
CAF-1, CAF-2, CAF-3, DESC
Medical subject headings
Post-Exercise Hypotension, Hypertension

What participants receive

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

  • CAF-1Other

    In this intervention the volunteers ingested one dose of caffeinated coffee containing 144 mg of caffeine

  • CAF-2Other

    In this intervention the volunteers ingested two doses of caffeinated coffee containing 288 mg of caffeine

  • CAF-3Other

    In this intervention the volunteers ingested three doses of caffeinated coffee containing 432mg of caffeine

  • DESCOther

    In this intervention the volunteers ingested one dose of decaffeinated coffee containing 108 mg of caffeine

Study groups in NCT02335840
Study groupRoleWhat they receive
One dose of coffeeExperimentalIngestion of one dose of 150 ml of coffee (144 mg of caffeine) ingested 10 minutes post-exercise (denominated CAF-1)
Receives: Other: CAF-1
Two doses of coffeeExperimentalIngestion of two doses of 150 ml of coffee (144 mg of caffeine) ingested 10 and 20 minutes post-exercise (denominated CAF-2)
Receives: Other: CAF-2
Three doses of coffeeExperimentalIngestion of three doses of 150 ml of coffee (144 mg of caffeine) ingested 10, 20 and 30minutes post-exercise (denominated CAF-3)
Receives: Other: CAF-3
Three doses of decaffeinated coffeeExperimentalIngestion of three doses of 150 ml of decaffeinated coffee (144 mg of caffeine) ingested 10, 20 and 30 minutes post-exercise (denominated DESC)
Receives: Other: DESC

What is being measured

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

  1. Systolic and diastolic blood pressure. The measures were evaluated for delta (difference between the values obtained in the period of recovery and baseline)

    The sessions CAF-1, CAF-2, CAF-3 and DESC were realized with interval of 72 hours between them, thus, each volunteer devoted an average 20 days to the study.

    Measured: The systolic and diastolic blood pressure were measured in CAF-1, CAF-2, CAF-3 and DESC after the baseline and during 120 minutes post-exercise each 10 minutes. Thus, were realized 13 measures of blood pressure in each experimental session.

Timeline

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

  1. First posted12 Jan 2015 (estimated)
  2. Study startMar 2011
  3. Primary completionMay 2014
  4. Study completionNov 2014

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
Allocation
Randomised
Intervention model
Crossover
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02335840
Sponsor's protocol ID
21/2011
Status last verified
Jan 2015
First submitted
23 Dec 2014
Last updated
12 Jan 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing CAF-1, CAF-2 and CAF-3 in people with Post-Exercise Hypotension and Hypertension, run by Federal University of Paraíba.

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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Systolic and diastolic blood pressure. The measures were evaluated for delta (difference between the values obtained in the period of recovery and baseline) (time frame: The systolic and diastolic blood pressure were measured in CAF-1, CAF-2, CAF-3 and DESC after the baseline and during 120 minutes post-exercise each 10 minutes. Thus, were realized 13 measures of blood pressure in each experimental session.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 12 Jan 2015.

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