EFFECTS of BEETROOT JUICE INTAKE and PHYSICAL EXERCISE in POSTMENOPAUSAL HYPERTENSIVE WOMEN

NCT06585904 | Active Not Recruiting DMC

• 3 other identifiers: 02.78649524.4.0000.5152APQ-01874-18175522/2023-5
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to verify the hemodynamic and biomarker responses of aerobic physical exercise and beetroot juice intake in postmenopausal women with hypertension. The main questions it seeks to answer are: Is beetroot juice and aerobic exercise related to better hemodynamic responses in hypertensive postmenopausal women? Is beetroot juice and aerobic exercise related to better oxidative stress profile responses in hypertensive postmenopausal women? The researchers will conduct a parallel clinical study with 10 days of intervention, in which 48 women will be randomized into 3 groups: 1) Aerobic exercise; 2) One shot of beetroot juice intake per day (400mg of NO3-); 3) Control (no intervention).

Conditions

Hypertensiona; Menopause

Keywords

beetroot juice; hypertension; postmenopausal; exercise; blood pressure

Outcome Measures

Primary Outcomes (1)

• Hemodynamic responses

  Volunteers will undergo blood pressure tests at the beginning, in the middle and after the 10 days of intervention. To assess blood pressure (BP), researchers will use the Dyna Mapa + Cardius® device, programmed with measurements to be taken every 20 min. Together with this device, the volunteers filled out a daily record of activities such as sleep, work, food, or any event that could interfere with BP or measurements. In a standardized manner, the device was set at 7 a.m., and measurements were considered valid when 24h of monitoring were obtained. Resting BP was measured with the same device after 15 min of rest in a sitting position, and for the analysis of the pressure curve, time 0 was adopted when the monitor was placed. Sytolic BP, diastolic BP, and mean BP in periods of awake, sleep and 24 h were analyzed.

  11 days

Secondary Outcomes (8)

• Stroop color and word test

  11 days

• Heart rate variability

  11 days

• Superoxide Dismutase

  11 days

• Catalase

  11 days

• Glutationa peroxidase

  11 days

Study Arms (3)

1 dose of beetroot juice

EXPERIMENTAL

The volunteer will ingest 1 dose of beetroot juice containing 400mg of inorganic nitrate for 10 days.

Dietary Supplement: 1 dose of Beetroot juice intake

Exercise

ACTIVE COMPARATOR

The volunteer will perform moderate aerobic exercise for 10 consultative days on a cycle ergometer.

Other: Exercise

Control

NO INTERVENTION

The volunteer will undergo initial assessments, will carry out the control without any intervention, for 10 consecutive days and will carry out the assessments afterwards.

Interventions

1 dose of Beetroot juice intake DIETARY_SUPPLEMENT

The volunteer will ingest 1 dose of beetroot juice containing 400mg of inorganic nitrate for 10 days.

1 dose of beetroot juice

Exercise OTHER

The volunteer will perform moderate aerobic exercise for 10 consultative days on a cyclergometer.

Exercise

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Amenorrhea for at least 12 months
• Controlled hypertension
• Suitable for physical exercise
• Present a certificate proving fitness to practice physical exercise

You may not qualify if:

• Decompensated hypertension in stages 2 and 3
• Having a history of stroke or acute myocardial infarction
• Smoker
• Having physical problems or cardiovascular complications that prevent physical exercise
• Having a diagnosis of Diabetes Mellitus
• Using hormone therapy.

Sponsors & Collaborators

• Federal University of Uberlandia: lead

Study Sites (1)

FAEFI

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Hypertension; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 19, 2024
• Study Start: August 7, 2024
• Primary Completion: July 1, 2025
• Study Completion (Estimated): December 1, 2028
• Last Updated: September 23, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)