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

NCT ID: NCT06585904

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-07
• Study Completion Date: 2028-12-31

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).

Detailed Description

The entire intervention will take place at the Physical Education campus of University, in the Cardiorespiratory and Metabolic Physiology Laboratory (LAFICAM). The recruitment and approach of the volunteers will occur through media dissemination, such as radio announcements, television programs, and social media through digital media. After the dissemination, volunteers will make contact via phone, email, or social media, and a preliminary registration will take place. After this registration, the researchers will verify which volunteers meet the inclusion criteria, and only then will the recruitment take place.

The volunteers will be invited to come to LAFICAM to be informed about the intervention program and then sign the informed consent form. Before starting the intervention program, all volunteers must present a medical certificate clearing them to participate in a physical exercise training program; once the certificate is submitted, initial tests and general evaluations will be conducted.

The initial evaluations will consist of a questionnaire, anthropometric and body composition assessment, and evaluation of the physical activity level. After the questionnaires are administered, a familiarization with the sensory perceptions of beetroot juice will be conducted. This familiarization is important to verify if the volunteers are fit to carry out the intervention.

The volunteers will be randomized into three groups: Group 1: The volunteers will perform a moderate physical exercise session lasting 40 minutes for 10 consecutive days; Group 2: this group will ingest 70 ml of beetroot juice with 400 mg of nitrate every morning for 10 days. Group 3: this group will ingest 70 ml of beetroot juice without nitrate for 10 days.

Conditions

Hypertensiona; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1 dose of beetroot juice

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

Group Type: EXPERIMENTAL

1 dose of Beetroot juice intake

Intervention Type: DIETARY_SUPPLEMENT

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

Exercise

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

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

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

Control

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

1 dose of Beetroot juice intake

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

Intervention Type: DIETARY_SUPPLEMENT

Exercise

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Ana Luiza Amaral Ribeiro

Researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

FAEFI

Uberlândia, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

APQ-01874-18

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

175522/2023-5

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

02.78649524.4.0000.5152

Identifier Type: -

Identifier Source: org_study_id