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

Federal University of Uberlandia

Status: Active, not recruiting

Conditions: Menopause; Hypertensiona

Treatments: Other: Exercise; Dietary Supplement: 1 dose of Beetroot juice intake

Study type: Interventional

Funder types: Other

Identifiers

NCT06585904

175522/2023-5 (Other Grant/Funding Number)

02.78649524.4.0000.5152

APQ-01874-18 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 48 estimated patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 3 patient groups

1 dose of beetroot juice

Experimental group

Description:

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

Treatment:

Dietary Supplement: 1 dose of Beetroot juice intake

Exercise

Active Comparator group

Description:

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

Treatment:

Other: Exercise

Control

No Intervention group

Description:

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.