- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02616822
Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients
Acute Effects Of Trans-Resveratrol in Endothelial Function in Treated Hypertensive Patients
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Outpatients aged between 45 and 65 years, of both genders.
- Patients with a previous diagnosis of hypertension.
- Patients with endothelial disfunction.
- Stable use of antihypertensive treatment for at least 2 months.
- Patients with food consumption maintained for at least 4 weeks, oriented to limit the intake of foods rich in polyphenols, such as peanut butter, cranberry, blackberry, red grapes, red wine, green tea and chocolate.
- Signing the consent form.
Exclusion Criteria:
- Smoking.
- Diabetes Mellitus and / or use of insulin or oral hypoglycemic agents.
- Hormone replacement therapy.
- Use of ß-blockers and statins.
- Sleep apnea.
- Changes in thyroid function, chronic renal and liver diseases.
- Clinically evident coronary heart disease with previous myocardial infarction and / or revascularization, with clinical signs of heart failure, cardiac arrhythmia, symptomatic or clinically significant valvular disease, prior stroke.
- History of drug or alcohol abuse. Presence of some kind of eating disorder;
- Diets restricted by choice (vegetarianism, carbohydrate restriction);
- Use of nutritional supplements (vitamins, minerals), to at least seven (7) days prior to the study;
- Patients who have any severe illness and life-threatening any condition, disease or therapy that, in the opinion of the investigator, may adversely affect the results, interfere with the study objectives or jeopardize the safety of patients.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: trans-resveratrol
Used for trans-resveratrol substance 300 mg single dose
|
Used for trans-resveratrol substance 300 mg single dose
|
Placebo Comparator: Placebo
Used for placebo substance single dose
|
Used for placebo substance single dose
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Flow-mediated dilatation of the brachial artery
Time Frame: 90 minutes
|
The patient lay comfortably in the supine position with slightly abducted right arm.
After located the brachial artery, the transducer was placed on the anteromedial face of the right arm, perpendicular to the axis of the arm, 5-10 cm above the antecubital crease on the artery.
The basal diameter of the brachial artery (BBAD) and post occlusion brachial artery diameter (POBAD) were measured manually between the intima-lumen interfaces at end-diastole.
After BBAD, the site of contact of the probe was marked on the skin, so that the measurement of POBAD occur at the same site.
The occlusion is maintained for five minutes through cuff on the arm, which print pressure slightly above the systolic blood pressure, confirmed by no pulse Doppler.
The POBAD was measured 30, 60 and 90 seconds after releasing the flow.
At baseline, after checking the criteria for inclusion and exclusion and signing the informed consent, the selected patient performs the DMF fasting and after 90 minutes.
|
90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determination of central aortic pressure (Sphygmocor)
Time Frame: 90 minutes
|
Noninvasive test, conducted in peaceful environment, temperature controlled, patient lying supine, using his right arm to measure blood pressure and central aortic pressure. The analysis of radial artery pulse wave by applanation tonometry is performed to derive central artery pressures and other hemodynamic parameters using Sphygmocor system (Atcor, USA). After measuring the BP in the brachial artery pulse wave of the radial artery on the same side were obtained for at least 10 seconds using a tonometer (SPC-301 - Millar Instruments, Houston, Texas), calibrated according to the brachial BP. The resulting radial pulse waves are processed using specific software (Sphygmocor v7 AtCor, USA) to derive the corresponding central aortic pressure through a previously validated transfer function. At baseline, after checking the criteria for inclusion and exclusion and signing the informed consent, the selected patient performs the SphymoCor fasting and after 90 minutes. |
90 minutes
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Resv2013
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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