Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-05 @ 3:02 PM
Study NCT ID:
NCT03620227
Status:
COMPLETED
Last Update Posted:
2019-02-20
First Post:
2018-05-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Beetroot Juice in Postmenopausal and Hypertensive
Sponsor:
Federal University of Uberlandia
Organization:
Study Overview
Official Title:
Effects of Beetroot Juice Supplementation in Response to Physical Exercise in Postmenopausal and Hypertensive Women
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The decrease in estrogen in postmenopausal women leads an increase in endocrine metabolic dysfunctions, such as changes in lipid profile and blood pressure. Thus, one of the alternatives for prevention and treatment is the practice of physical exercise associated with diet containing precursors of nitric oxide (NO), which is a potent vasodilator. Therefore, this study intends to verify if supplementation of beetroot juice changes the hemodynamic and salivary markers in postmenopausal and hypertensive women. Therefore, the intervention consists of 350ml of concentrated beetroot juice or placebo, which will be ingested in fasting. After 2 hours will be carried out a session of aerobic physical exercise in treadmill and blood pressure will be measured each 15 minutes for 90 minutes after the end of the session, in addition to the 24-hour measurement that will be performed by an ABPM device. Salivary samples will be held: before the juice ingest, right after exercise, 90 minutes after and 24 hours after the end of the exercise. With the development of this study, it is expected to find blood pressure reduction and normalization of the inflammatory profile through salivary samples, after the period of supplementation associated with physical exercise practice.
Detailed Description:
The intervention protocol will last 3 days. On the first day there will be the collection of anthropometric data, the signature of a consent term and delivery of the list of foods that should be avoided 24 hours before the tests and a treadmill familiarization. On the second and third day the physical intervention will be performed associated with juice or placebo supplementation. A wash out period of at least 7 days will be performed between the second and third day. The volunteers will arrive at the laboratory at 7am in the fasted state and will be rested until 07:20am and then the blood pressure (BP) measurement (collected three times, with an interval of 1 minute between measurements), collection of the saliva and the measurement of heart rate (HR). Approximately at 07:30am they will start drinking the juice and will have up to 15 minutes to consume. BP will be measured at 08:00am, 08:30am, 09:00am and 09:30am. At 9:30am a physical exercise session will begin, during which will be monitored by a cardio-frequency monitor, which will remain until 11h10am (period referring to the end of BP monitoring in the laboratory). At 10:10am the workout will be finished, and then the saliva will be collected. After this period, the volunteers can take up to 250 ml of water until 11:10am, and every 15 minutes, BP will also be measured. and at 11:10am a collection of saliva will be performed. The volunteers will have the period of 15 minutes to be hygienised, and at 11:25am the ABPM will be placed (ambulatory blood pressure monitor). The ABPM will be taken the day after the test at 10:10 am (time for the first post-exercise BP measurement), and the last collection of saliva will be carried out concurrently with the ABPM removal.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: