Clinical trial NCT06584331: BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN
Official title: HEMODYNAMIC and BIOCHEMICAL RESPONSES to 10 DAYS of BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertension
Menopause
Keywords: beetroot juice
hypertension
postmenopausal
blood pressure
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2024-09-04
Enrollment: 48
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Blood Pressure
timeFrame: 11 days
Secondary outcomes:
measure: Stroop color and word test
timeFrame: 11 days
measure: Heart rate variability
timeFrame: 11 days
measure: Superoxide Dismutase
timeFrame: 11 days
measure: Catalase
timeFrame: 11 days
measure: Glutathione Peroxidase
timeFrame: 11 days
measure: Total antioxidant capacity due to ferric-reducing antioxidant power (FRAP)
timeFrame: 11 days
measure: Reduced glutathione (GSH)
timeFrame: 11 days
measure: Human cytokines
timeFrame: 11 days
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: FAEFI
state: Minas Gerais
Study officials:
References: