NCT02335840

Brief 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. 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2011

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2014

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 12, 2015

Completed
Last Updated

January 12, 2015

Status Verified

January 1, 2015

Enrollment Period

3.2 years

First QC Date

December 23, 2014

Last Update Submit

January 7, 2015

Conditions

Outcome Measures

Primary Outcomes (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.

    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.

Study Arms (4)

One dose of coffee

EXPERIMENTAL

Ingestion of one dose of 150 ml of coffee (144 mg of caffeine) ingested 10 minutes post-exercise (denominated CAF-1)

Other: CAF-1

Two doses of coffee

EXPERIMENTAL

Ingestion of two doses of 150 ml of coffee (144 mg of caffeine) ingested 10 and 20 minutes post-exercise (denominated CAF-2)

Other: CAF-2

Three doses of coffee

EXPERIMENTAL

Ingestion of three doses of 150 ml of coffee (144 mg of caffeine) ingested 10, 20 and 30minutes post-exercise (denominated CAF-3)

Other: CAF-3

Three doses of decaffeinated coffee

EXPERIMENTAL

Ingestion of three doses of 150 ml of decaffeinated coffee (144 mg of caffeine) ingested 10, 20 and 30 minutes post-exercise (denominated DESC)

Other: DESC

Interventions

CAF-1OTHER

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

One dose of coffee
CAF-2OTHER

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

Two doses of coffee
CAF-3OTHER

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

Three doses of coffee
DESCOTHER

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

Three doses of decaffeinated coffee

Eligibility Criteria

Age40 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Post-Exercise HypotensionHypertension

Condition Hierarchy (Ancestors)

Orthostatic IntolerancePrimary DysautonomiasAutonomic Nervous System DiseasesNervous System DiseasesHypotensionVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Master Student

Study Record Dates

First Submitted

December 23, 2014

First Posted

January 12, 2015

Study Start

March 1, 2011

Primary Completion

May 1, 2014

Study Completion

November 1, 2014

Last Updated

January 12, 2015

Record last verified: 2015-01