Effects of Trans-Resveratrol in Endothelial Function in Hypertensive Patients

NCT02616822 | Completed Phase 1 DMC

• 1 other identifier: Resv2013
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Flow-mediated dilatation of the brachial artery

  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 Outcomes (1)

• Determination of central aortic pressure (Sphygmocor)

  90 minutes

Study Arms (2)

trans-resveratrol

EXPERIMENTAL

Used for trans-resveratrol substance 300 mg single dose

Dietary Supplement: Trans-resveratrol

Placebo

PLACEBO COMPARATOR

Used for placebo substance single dose

Other: Placebo

Interventions

Trans-resveratrol DIETARY_SUPPLEMENT

Used for trans-resveratrol substance 300 mg single dose

trans-resveratrol

Placebo OTHER

Used for placebo substance single dose

Placebo

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario Pedro Ernesto: lead

MeSH Terms

Conditions

Hypertension

Interventions

Resveratrol

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RD, Master student

Study Record Dates

• First Submitted: October 16, 2015
• First Posted: November 30, 2015
• Study Start: January 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 30, 2015

Record last verified: 2015-11