Effect of Antioxidant Supplementation on the Autonomic Balance

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03510221
• Other study ID #: Hyperox
• Status: Completed
• Phase: N/A
• First received: March 29, 2018
• Last updated: April 25, 2018
• Start date: January 2016
• Est. completion date: December 2016

Study information

• Verified date: January 2016
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Autonomic Imbalance
• Hypertension
• Insulin Resistance
• Oxidative Stress

Intervention

Dietary Supplement:
• Antioxidants capsules
1 capsule of cranberry, 1 capsule of blueberry, and 1 capsule of pomegranate extracts were offered during 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Effect of antioxidants on insulin resistance in 29 normotensive subjects and 30 hypertensive patients	Supplementation with antioxidants should improve insulin resistance	4 weeks
Secondary	Effect of antioxidants on blood pressure in 29 normotensive subjects and 30 hypertensive patients	Supplementation with antioxidants should improve blood pressure	4 weeks
Secondary	Effect of antioxidants on antioxidant capacity in 29 normotensive subjects and 30 hypertensive patients	Supplementation with antioxidants should improve antioxidant capacity	4 weeks