BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN

NCT ID: NCT06584331

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 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-).

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 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.

Conditions

Hypertension; Menopause

Study Design

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

Study Groups

1 dose of beetroot juice

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

Group Type: EXPERIMENTAL

1 dose of Beetroot juice intake

Intervention Type: DIETARY_SUPPLEMENT

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

2 doses of beetroot juice

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

Group Type: EXPERIMENTAL

2 doses of Beetroot juice intake

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

In this group, the participants will receive 70ml of low-nitrate beetroot juice to consume in the morning.

Interventions

1 dose of Beetroot juice intake

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

Intervention Type: DIETARY_SUPPLEMENT

2 doses of Beetroot juice intake

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

In this group, the participants will receive 70ml of low-nitrate beetroot juice to consume in the morning.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• 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

Principal Investigator

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

01.78649524.4.0000.5152

Identifier Type: -

Identifier Source: org_study_id