Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06585904
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
EFFECTS of BEETROOT JUICE INTAKE and PHYSICAL EXERCISE in POSTMENOPAUSAL HYPERTENSIVE WOMEN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EFFECTS of BEETROOT JUICE INTAKE and PHYSICAL EXERCISE in POSTMENOPAUSAL HYPERTENSIVE WOMEN a RANDOMIZED PLACEBO-CONTROLLED STUDY
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EBJPEPHW
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None