Clinical trial NCT03620227: Effects of Beetroot Juice in Postmenopausal and Hypertensive
Official title: Effects of Beetroot Juice Supplementation in Response to Physical Exercise in Postmenopausal and Hypertensive Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Menopause
Keywords: Combined Exercise
Beetroot juice
Women health
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
name: Fundação de Amparo à Pesquisa do estado de Minas Gerais
First posted: 2018-08-08
Enrollment: 13
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The volunteers will do 2 days of intervention in random order with 7 days of wash out. In one of the days will consume 350ml of concentrated beet juice and in the other 350ml of placebo made with the juice itself denitratized by an anionic resin that does not alter taste, smell or color.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in rest Blood Pressure
timeFrame: Before and 15, 30, 45 and 60 minutes after exercise sessions
measure: Changes in Ambulatorial Blood Pressure
timeFrame: Every 15 minutes during 24 hours from 60 minutes after exercise
Secondary outcomes:
measure: Changes in Heart Rate Variability
timeFrame: During the 20 minutes before and after the exercise and during the execution of the exercise.
measure: Changes in salivary oxidative stress
timeFrame: Before supplementation, right after, 60 minutes and 24 hour after exercise sessions
measure: Changes in Ambulatorial Blood Pressure Variability
timeFrame: Every 15 minutes during 24 hours from 60 minutes after exercise
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Guilherme Morais Puga
state: Minas Gerais
Study officials:
affiliation: Federal University of Uberlandia
name: Guilherme M Guilherme, Phd
role: PRINCIPAL_INVESTIGATOR
References: