Effect of Antioxidant Supplementation on the Autonomic Balance

Effects of Supplementation of Fruit Extract (Cranberry, Blueberry and Pomegranate) on Blood Pressure, Autonomic Balance, Insulin Resistance and Oxidative Stress in Hypertensive Patients

Recent evidence suggests that there is a directly proportional relationship between diets with a high concentration of antioxidants and the reduction of blood pressure and the risk of cardiovascular events. However, there is a gap with regard to research on the effects of these diets on vascular function, especially in humans. The aim of this study was to evaluate the effect of antioxidant supplementation through the consumption of blueberry, cranberry and pomegranate extract capsules (1 of each per day), the effect of the autonomic balance in hypertensive and normotensive adults.

Study Overview

• Status: Completed
• Conditions: Hypertension; Insulin Resistance; Oxidative Stress; Autonomic Imbalance
• Intervention / Treatment: Dietary supplement: Antioxidants capsules

Detailed Description

A clinical trial was performed, with 60 individuals, 30 normotensive and 30 hypertensive patients. Participants were of both sex, aged between 18 and 60 years and Body Mass Index (BMI) less than 35 kg / m². Venous blood samples were collected after 12-hour fasting for biochemical measurements (glucose, total cholesterol and LDL-cholesterol, HDL-cholesterol, triglycerides, uric acid, sodium, potassium, urea, creatinine, insulin), and adiponectin , interleukin-4 (IL-4), interleukin-2β (IL-2β), monocyte chemoattractant protein-1 (MCP-1), leptin, C-reactive protein, tumor necrosis factor alpha (TNF-α), interleukin-6 and nitrotyrosine. An anthropometric evaluation was performed with measures of weight, height, waist circumference and cervical circumference. The hemodynamic evaluation was done through a non-invasive monitor. The study participants were divided into 2 different groups: Group A (normotensive) and Group B (hypertensive). The capsules for antioxidant supplementation were of blueberry, cranberry and pomegranate, being one capsule of each a day. Study participants received placebo capsules for 4 weeks and then received the fruit extract capsules (blueberry, cranberry and pomegranate), one capsule a day for 4 weeks. All tests were performed at baseline, after 4 and 8 weeks of intervention. The comparison between groups was performed with the Multiple Comparison Test (ANOVA). The research project was approved by the Ethics Committee for Analysis of Research Projects (CAPPesq) of the Hospital das Clinicas of the Faculty of Medicine of the University of Sao Paulo. Participation in the research was voluntary and all participants read and signed the consent form. The risk for the present participant was minimal.

• Study Type: Interventional
• Enrollment (Actual): 54
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of hypertension - group Hypertensives
• Healthy people - group Normotensive

Exclusion Criteria:

• Patients with glycated hemoglobin > 7%,
• Patients with a diagnosis of cardiovascular disease,
• Patients with LDL-cholesterol> 160 mg/dL (non-diabetics)
• Pregnant women,
• Cigarret smokers,
• Diabetics using more than one drug in addition to metformin,
• Patients with LDL-cholesterol> 130 mg/dL (non-diabetic using statin),
• LDL cholesterol ≥ 100 mg / dL (patients on statin),
• Patients with valvular heart disease,
• Pulmonary hypertension,
• Patients with collagen disease,
• Patients with type of cancer,
• Complex arrhythmia,
• Those patients with any chronic crippling pathology.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Antioxidants; Subjects received 3 antioxidant capsules (1 capsule of blueberry + 1 capsule of cranberry + 1 capsule pomegranate - a day) during 4 weeks.	Dietary supplement: Antioxidants capsules; 1 capsule of cranberry, 1 capsule of blueberry, and 1 capsule of pomegranate extracts were offered during 4 weeks
Placebo Comparator: Placebo; Subjects received 3 placebo capsules during 4 weeks.	Dietary supplement: Antioxidants capsules; 1 capsule of cranberry, 1 capsule of blueberry, and 1 capsule of pomegranate extracts were offered during 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of antioxidants on heart rate variability in 29 normotensive subjects and 30 hypertensive patients	Antioxidant supplementation should improve heart rate variability as a consequence of improved antioxidant capacity	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effect of antioxidants on insulin resistance in 29 normotensive subjects and 30 hypertensive patients	Supplementation with antioxidants should improve insulin resistance	4 weeks
Effect of antioxidants on blood pressure in 29 normotensive subjects and 30 hypertensive patients	Supplementation with antioxidants should improve blood pressure	4 weeks
Effect of antioxidants on antioxidant capacity in 29 normotensive subjects and 30 hypertensive patients	Supplementation with antioxidants should improve antioxidant capacity	4 weeks

Collaborators and Investigators

• Sponsor: University of Sao Paulo General Hospital
• Collaborators: Fundação de Amparo à Pesquisa do Estado de São Paulo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 25, 2018
• First Posted (Actual): April 27, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2018
• Last Update Submitted That Met QC Criteria: April 25, 2018
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Oxidative stress; Insulin resistance; Hypertension; Cytokines; Antioxidant; Autonomic imbalance
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Hypertension; Insulin Resistance; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants
• Other Study ID Numbers: Hyperox

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No