Effects of Beetroot Juice in Postmenopausal and Hypertensive

NCT ID: NCT03620227

Last Updated: 2019-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-02-01
• Study Completion Date: 2019-02-11

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.

Conditions

Hypertension; Menopause

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Beetroot juice

ingestion of beetroot juice before an exercise session.

Group Type: EXPERIMENTAL

Exercise

Intervention Type: OTHER

40 minutes of aerobic exercise on a treadmill, with a fixed speed of 5.5 km/h and intensity imposed by treadmill inclination until it reaches the frequency zone between 60% and 75% of the reserve heart rate.

Beetroot juice

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of 350ml of concentrated beetroot juice (400mg of nitrate) 100 minutes before an exercise session.

Placebo

ingestion of placebo before an exercise session.

Group Type: PLACEBO_COMPARATOR

Exercise

Intervention Type: OTHER

40 minutes of aerobic exercise on a treadmill, with a fixed speed of 5.5 km/h and intensity imposed by treadmill inclination until it reaches the frequency zone between 60% and 75% of the reserve heart rate.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Ingestion of 350ml of placebo (0mg of nitrate, with the same color, taste and smell) 100 minutes before an exercise session.

Interventions

Exercise

40 minutes of aerobic exercise on a treadmill, with a fixed speed of 5.5 km/h and intensity imposed by treadmill inclination until it reaches the frequency zone between 60% and 75% of the reserve heart rate.

Intervention Type: OTHER

Beetroot juice

Ingestion of 350ml of concentrated beetroot juice (400mg of nitrate) 100 minutes before an exercise session.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Ingestion of 350ml of placebo (0mg of nitrate, with the same color, taste and smell) 100 minutes before an exercise session.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Exercise session

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.

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do estado de Minas Gerais

OTHER

Sponsor Role: collaborator

Federal University of Uberlandia

OTHER

Sponsor Role: lead

Responsible Party

Ana Luiza Amaral Ribeiro

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guilherme M Guilherme, Phd

Role: PRINCIPAL_INVESTIGATOR

Federal University of Uberlandia

Locations

Guilherme Morais Puga

Uberlândia, Minas Gerais, Brazil

Countries

Brazil

Other Identifiers

CEP UFU 70104717.0.0000.5152

Identifier Type: -

Identifier Source: org_study_id