Hypertension Clinical Trial
Official title:
Effects of Beetroot Juice Supplementation in Response to Physical Exercise in Postmenopausal and Hypertensive Women
Verified date | February 2019 |
Source | Federal University of Uberlandia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 13 |
Est. completion date | February 11, 2019 |
Est. primary completion date | August 1, 2018 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 50 Years to 70 Years |
Eligibility |
Inclusion Criteria: - Women aged between 50 and 70 years; - Amenorrhea of at least 12 months; - Being in the postmenopausal phase; - Be controlled hypertension; - Be able to practice physical exercises on cycle ergometers; - Submit a certificate attesting to the ability to practice physical exercises. Exclusion Criteria: - Be uncompensated hypertensive in stages 2 and 3; - To present a history of stroke or acute myocardial infarction; - Be a smoker; - To present physical problems or cardiovascular complications that prevent the performance of physical exercises. - To present a diagnosis of Diabetes Mellitus; - To present renal pathologies; - To present gastrointestinal pathologies; - Have hypersensitivity to nitrate; - Make use of hormonal therapies. |
Country | Name | City | State |
---|---|---|---|
Brazil | Guilherme Morais Puga | Uberlândia | Minas Gerais |
Lead Sponsor | Collaborator |
---|---|
Federal University of Uberlandia | Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in rest Blood Pressure | After 15 minutes of total rest, Systolic, Diastolic and Mean blood pressure will be measured by automatic device 3 times with one minute between measurements. | Before and 15, 30, 45 and 60 minutes after exercise sessions | |
Primary | Changes in Ambulatorial Blood Pressure | All volunteers were submitted to a 24-hour Blood Pressure (BP) assessment by Ambulatorial Blood Pressure Monitoring (ABPM) 60 minutes after exercise. A device was used associated with a diary of examination to self-report of activities of daily living (sleep, work, food) or any event that could interfere abnormally with BP or device measurements. The device was always placed 7am and the measurements were made every 15 minutes from 7h to 23h and every 30 minutes from 23h to 7h. The monitoring was considered valid when it happened for a period of 24 hours. The following results were evaluated: systolic blood pressure; diastolic blood pressure, mean blood pressure and heart rate in awake, sleep and 24-hour periods. | Every 15 minutes during 24 hours from 60 minutes after exercise | |
Secondary | Changes in Heart Rate Variability | Heart Rate (HR) was recorded using a heart rate monitor in a beat-by-beat basis. HR was registered in a seat position for 20 min of rest. Prior to the HR Variability (HRV) analysis, the RR intervals (RRi) were visually inspected and filtered using a moving average filter. The HRV was analyzed in both time-, frequency- and nonlinear-domain. Being that for frequency-domain analysis, firstly the RRi series were interpolated at 4 Hz and then the signal linear trend component removal was performed using the smooth priors approach. | During the 20 minutes before and after the exercise and during the execution of the exercise. | |
Secondary | Changes in salivary oxidative stress | The salivary was collected after 12-hours fasting and the total antioxidant capacity was evaluated using the Ferric-Ability of Plasma (FRAP) methodology and calculated from the standard trolox curve. The activity of the enzyme superoxide dismutase (SOD) was determined based on the auto oxidation capacity of pyrogallol and catalase activity (CAT) by monitoring the consumption of hydrogen peroxide at 240 nm. Lipid peroxidation levels were determined by the TBARS method (thiobarbituric acid reactive substances), using as standard a curve of 1,1,3,3-tetraethoxypropane (TMP). The total protein concentration was obtained by the Bradford method (BRADFORD, 1976), using bovine serum albumin (BSA) as standard. The amounts of nitric oxide (NO) were estimated by the determination of total nitrite by the Griess colorimetric method. | Before supplementation, right after, 60 minutes and 24 hour after exercise sessions | |
Secondary | Changes in Ambulatorial Blood Pressure Variability | Based on Systolic, Diastolic and Mean Ambulatorial Blood Pressure data, were calculated Blood Pressure Variability by: 24-hour standard deviation weighted by the time interval between consecutive readings; the mean diurnal and nocturnal deviations weighted for the duration of the daytime and nighttime interval; the average real variability weighted for the time interval between consecutive readings; the ambulatory arterial stiffness index calculated by the slope of the trend curve of the dispersion of pressure data; the morning surge that represents the dynamic daytime variation in morning pressure that tends to increase, being assessed from the point of least pressure during sleep in relation to the first two hours after waking; and nocturnal dipping, that represents the average percentage drop of sleep pressure in relation to wakefulness, and individuals with falls of 10% or more are considered dippers and below that are considered nom-dippers. | Every 15 minutes during 24 hours from 60 minutes after exercise |
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