Effects of Beetroot Juice in Postmenopausal and Hypertensive

NCT03620227 | Completed DMC

• 1 other identifier: CEP UFU 70104717.0.0000.5152
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Menopause

Keywords

Combined Exercise; Beetroot juice; Women health

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Changes in Heart Rate Variability

  During the 20 minutes before and after the exercise and during the execution of the exercise.

• Changes in salivary oxidative stress

  Before supplementation, right after, 60 minutes and 24 hour after exercise sessions

• Changes in Ambulatorial Blood Pressure Variability

  Every 15 minutes during 24 hours from 60 minutes after exercise

Study Arms (2)

Beetroot juice

EXPERIMENTAL

ingestion of beetroot juice before an exercise session.

Other: Exercise; Dietary Supplement: Beetroot juice

Placebo

PLACEBO COMPARATOR

ingestion of placebo before an exercise session.

Other: Exercise; Dietary Supplement: Placebo

Interventions

Exercise 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.

Also known as: Exercise session

Beetroot juice; Placebo

Beetroot juice DIETARY_SUPPLEMENT

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

Beetroot juice

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Federal University of Uberlandia: lead
• Conselho Nacional de Desenvolvimento Científico e Tecnológico: collaborator
• Fundação de Amparo à Pesquisa do estado de Minas Gerais: collaborator

Study Sites (1)

Guilherme Morais Puga

Uberlândia, Minas Gerais, 38400-678, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Exercise

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Guilherme M Guilherme, Phd

  Federal University of Uberlandia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The preparation and coding of the liquids will be performed by a third party so that the researchers and participants will not know which liquid is being consumed.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: August 8, 2018
• Study Start: February 1, 2018
• Primary Completion: August 1, 2018
• Study Completion: February 11, 2019
• Last Updated: February 20, 2019

Record last verified: 2019-02

Locations

BR (1)