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Effect of Antioxidant Supplementation on the Autonomic Balance

Primary Purpose

Hypertension, Oxidative Stress, Autonomic Imbalance

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Antioxidants capsules
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Hypertension, Oxidative stress, Antioxidant, Autonomic imbalance, Insulin resistance, Cytokines

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Antioxidants

    Placebo

    Arm Description

    Subjects received 3 antioxidant capsules (1 capsule of blueberry + 1 capsule of cranberry + 1 capsule pomegranate - a day) during 4 weeks.

    Subjects received 3 placebo capsules during 4 weeks.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Effect of antioxidants on insulin resistance in 29 normotensive subjects and 30 hypertensive patients
    Supplementation with antioxidants should improve insulin resistance
    Effect of antioxidants on blood pressure in 29 normotensive subjects and 30 hypertensive patients
    Supplementation with antioxidants should improve blood pressure
    Effect of antioxidants on antioxidant capacity in 29 normotensive subjects and 30 hypertensive patients
    Supplementation with antioxidants should improve antioxidant capacity

    Full Information

    First Posted
    March 29, 2018
    Last Updated
    April 25, 2018
    Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03510221
    Brief Title
    Effect of Antioxidant Supplementation on the Autonomic Balance
    Official Title
    Effects of Supplementation of Fruit Extract (Cranberry, Blueberry and Pomegranate) on Blood Pressure, Autonomic Balance, Insulin Resistance and Oxidative Stress in Hypertensive Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (Actual)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    December 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Sao Paulo General Hospital
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hypertension, Oxidative Stress, Autonomic Imbalance, Insulin Resistance
    Keywords
    Hypertension, Oxidative stress, Antioxidant, Autonomic imbalance, Insulin resistance, Cytokines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    A group of hypertensive patients and a group of normotensive individuals
    Masking
    Participant
    Allocation
    Non-Randomized
    Enrollment
    54 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Antioxidants
    Arm Type
    Active Comparator
    Arm Description
    Subjects received 3 antioxidant capsules (1 capsule of blueberry + 1 capsule of cranberry + 1 capsule pomegranate - a day) during 4 weeks.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Subjects received 3 placebo capsules during 4 weeks.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    Antioxidants capsules
    Intervention Description
    1 capsule of cranberry, 1 capsule of blueberry, and 1 capsule of pomegranate extracts were offered during 4 weeks
    Primary Outcome Measure Information:
    Title
    Effect of antioxidants on heart rate variability in 29 normotensive subjects and 30 hypertensive patients
    Description
    Antioxidant supplementation should improve heart rate variability as a consequence of improved antioxidant capacity
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Effect of antioxidants on insulin resistance in 29 normotensive subjects and 30 hypertensive patients
    Description
    Supplementation with antioxidants should improve insulin resistance
    Time Frame
    4 weeks
    Title
    Effect of antioxidants on blood pressure in 29 normotensive subjects and 30 hypertensive patients
    Description
    Supplementation with antioxidants should improve blood pressure
    Time Frame
    4 weeks
    Title
    Effect of antioxidants on antioxidant capacity in 29 normotensive subjects and 30 hypertensive patients
    Description
    Supplementation with antioxidants should improve antioxidant capacity
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

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