Clinical trial NCT06585904: EFFECTS of BEETROOT JUICE INTAKE and PHYSICAL EXERCISE in POSTMENOPAUSAL HYPERTENSIVE WOMEN
Official title: EFFECTS of BEETROOT JUICE INTAKE and PHYSICAL EXERCISE in POSTMENOPAUSAL HYPERTENSIVE WOMEN: a RANDOMIZED, PLACEBO-CONTROLLED STUDY
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Hypertensiona
Menopause
Keywords: beetroot juice
hypertension
postmenopausal
exercise
blood pressure
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2024-09-19
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 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.

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.

Primary outcomes:
measure: Hemodynamic responses
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: Glutationa 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: MG
Study officials:
References: