Clinical trial NCT02616822: Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients
Official title: Acute Effects Of Trans-Resveratrol in Endothelial Function in Treated Hypertensive Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Endothelial Dysfunction
Keywords: hypertension
endothelium
resveratrol
clinical trials
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
First posted: 2015-11-30
Enrollment: 24
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Arterial Hypertension (HBP) has a high prevalence and low rates of control, is considered a major modifiable risk factors and one of the most important public health problems. Mortality from cardiovascular disease increases progressively with increasing blood pressure (BP) in a linear, continuous and independent. The pathophysiological mechanisms involved in the pathogenesis of hypertension exhibit metabolic abnormalities, which are related to endothelial dysfunction. Resveratrol, a polyphenol stilbene derived from various species of plants, but in our food, mainly present in red wine and grapes, has shown protective effects in cardiovascular diseases, such as preventing the damage caused by oxidative stress, decreased plasma lipids with inhibiting the formation of atherosclerotic plaque; protective effect of vascular endothelium, with increased release of nitric oxide and decreased production of free radicals in animal models, but human studies are limited and insufficient to clarify the possible effects of trans-resveratrol (biologically active form) on endothelial function, blood pressure and central aortic pressure in treated hypertensive individuals.The aim of this study is to evaluate the acute effects of trans-resveratrol supplementation on endothelial function in treated hypertensive patients.


Eligibility criteria: 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.

Primary outcomes:
measure: Flow-mediated dilatation of the brachial artery
timeFrame: 90 minutes
Secondary outcomes:
measure: Determination of central aortic pressure (Sphygmocor)
timeFrame: 90 minutes
Other outcomes:
Locations:
Study officials:
References: