Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06584331
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN
Sponsor:
None
Organization:
None
Study Overview
Official Title:
HEMODYNAMIC and BIOCHEMICAL RESPONSES to 10 DAYS of BEETROOT JUICE INTAKE in POSTMENOPAUSAL HYPERTENSIVE WOMEN
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:
EBJIPHW
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-
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
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
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