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
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
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
NCT ID
NCT03510221
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
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
Learn more about this trial
Effect of Antioxidant Supplementation on the Autonomic Balance
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