BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN (EBJIPHW)

Federal University of Uberlandia

Status: Active, not recruiting

Conditions: Hypertension; Menopause

Treatments: Dietary Supplement: 2 doses of Beetroot juice intake; Dietary Supplement: Placebo; Dietary Supplement: 1 dose of Beetroot juice intake

Study type: Interventional

Funder types: Other

Identifiers

NCT06584331

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

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

01.78649524.4.0000.5152

Details and patient eligibility

About

The goal of this clinical trial is to verify the hemodynamic and biomarker responses of beetroot juice intake in postmenopausal women with hypertension. The main questions it aims to answer are:

Is beetroot juice dose related to better hemodynamic responses in hypertensive postmenopausal women? Is beetroot juice dose related to better oxidative stress profile responses in hypertensive postmenopausal women?

The investigators will conduct a parallel clinical study with 10 days of intervention, in which 48 women will be randomized into 3 groups: 1) Two shots of beetroot juice intake per day (800mg of NO3-); 2) One shot of beetroot juice intake per day (400mg of NO3-); 3) placebo intake (beetroot juice without NO3-).

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 ingest two shots containing 70 ml of beetroot juice with 400 mg of nitrate per day, one shot in the mornig and one shot at night, for 10 days; Group 2: this group will intake 70 ml of beetroot juice with 400 mg of nitrate every morning.

Group 3: this group will intake 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

Exclusion criteria

• Decompensated hypertension in stages 2 and 3
• Having a history of stroke or acute myocardial infarction
• Smoker
• 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, including a placebo group

1 dose of beetroot juice

Experimental group

Description:

The volunteers will ingest 70 ml of beetroot juice with 400 mg of nitrate every morning for 10 days

Treatment:

Dietary Supplement: 1 dose of Beetroot juice intake

2 doses of beetroot juice

Experimental group

Description:

This group will ingest 2 shots of 70 ml of beetroot juice with 400mg of nitrate, in each shot, for 10 days.

Treatment:

Dietary Supplement: 2 doses of Beetroot juice intake

Placebo

Placebo Comparator group

Description:

In this group, the participants will receive a low-nitrate beetroot juice dose to consume in the morning.

Treatment:

Dietary Supplement: Placebo