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Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients

H

Hospital Universitario Pedro Ernesto

Status and phase

Completed
Phase 1

Conditions

Endothelial Dysfunction

Treatments

Other: Placebo
Dietary Supplement: Trans-resveratrol

Study type

Interventional

Funder types

Other

Identifiers

NCT02616822
Resv2013

Details and patient eligibility

About

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.

Enrollment

24 patients

Sex

All

Ages

45 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

24 participants in 2 patient groups, including a placebo group

trans-resveratrol
Experimental group
Description:
Used for trans-resveratrol substance 300 mg single dose
Treatment:
Dietary Supplement: Trans-resveratrol
Placebo
Placebo Comparator group
Description:
Used for placebo substance single dose
Treatment:
Other: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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