Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients

NCT ID: NCT02616822

Last Updated: 2015-11-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2015-09-30

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.

Conditions

Endothelial Dysfunction

Keywords

hypertension; endothelium; resveratrol; clinical trials

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

trans-resveratrol

Used for trans-resveratrol substance 300 mg single dose

Group Type: EXPERIMENTAL

Trans-resveratrol

Intervention Type: DIETARY_SUPPLEMENT

Used for trans-resveratrol substance 300 mg single dose

Placebo

Used for placebo substance single dose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Used for placebo substance single dose

Interventions

Trans-resveratrol

Used for trans-resveratrol substance 300 mg single dose

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Used for placebo substance single dose

Intervention Type: OTHER

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role: lead

Responsible Party

Bianca Cristina Antunes Alves Marques

RD, Master student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

Resv2013

Identifier Type: -

Identifier Source: org_study_id