Clinical Trials Directory

Trials / Active Not Recruiting

Active Not RecruitingNCT06585904

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

EFFECTS of BEETROOT JUICE INTAKE and PHYSICAL EXERCISE in POSTMENOPAUSAL HYPERTENSIVE WOMEN: a RANDOMIZED, PLACEBO-CONTROLLED STUDY

Status
Active Not Recruiting
Phase
N/A
Study type
Interventional
Enrollment
48 (estimated)
Sponsor
Federal University of Uberlandia · Academic / Other
Sex
Female
Age
45 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENT1 dose of Beetroot juice intakeThe volunteer will ingest 1 dose of beetroot juice containing 400mg of inorganic nitrate for 10 days.
OTHERExerciseThe volunteer will perform moderate aerobic exercise for 10 consultative days on a cyclergometer.

Timeline

Start date
2024-08-07
Primary completion
2025-07-01
Completion
2028-12-01
First posted
2024-09-19
Last updated
2024-09-23

Locations

1 site across 1 country: Brazil

Source: ClinicalTrials.gov record NCT06585904. Inclusion in this directory is not an endorsement.