Effect of Antioxidant Supplementation on the Autonomic Balance

Sponsor

University of Sao Paulo General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03510221

Collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo (Other)

Enrollment

Arms

Actual Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Oxidative Stress Autonomic Imbalance Insulin Resistance	Dietary Supplement: Antioxidants capsules	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

54 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

A group of hypertensive patients and a group of normotensive individualsA group of hypertensive patients and a group of normotensive individuals

Masking:

Single (Participant)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Jan 1, 2016

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Effect of antioxidants on heart rate variability in 29 normotensive subjects and 30 hypertensive patients [4 weeks]
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 [4 weeks]
Supplementation with antioxidants should improve insulin resistance
Effect of antioxidants on blood pressure in 29 normotensive subjects and 30 hypertensive patients [4 weeks]
Supplementation with antioxidants should improve blood pressure
Effect of antioxidants on antioxidant capacity in 29 normotensive subjects and 30 hypertensive patients [4 weeks]
Supplementation with antioxidants should improve antioxidant capacity