HypertensionNCT03620227
Effects of Beetroot Juice in Postmenopausal and Hypertensive
A study testing Exercise and Beetroot juice in people with Hypertension and Menopause, run by Federal University of Uberlandia at 1 site in Brazil.
Trial 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)… Read more about this study
- Who is it for?
- Ages 50 to 70 years, women only
- Conditions the study is for
- Hypertension, Menopause
- What is being tested?
- Exercise and Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Feb 2018to 11 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- To present gastrointestinal pathologies;
- Have hypersensitivity to nitrate;
- Make use of hormonal therapies.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Beetroot Juice Supplementation in Response to Physical Exercise in Postmenopausal and Hypertensive Women
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.
Read the 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
- Being tested
- Exercise, Beetroot juice, Placebo
- Keywords
- Combined Exercise, Beetroot juice, Women health
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Also called Exercise session
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 juiceDietary supplement
Ingestion of 350ml of concentrated beetroot juice (400mg of nitrate) 100 minutes before an exercise session.
PlaceboDietary supplement
Ingestion of 350ml of placebo (0mg of nitrate, with the same color, taste and smell) 100 minutes before an exercise session.
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice | Experimental | ingestion of beetroot juice before an exercise session. Receives: Other: Exercise; Dietary Supplement: Beetroot juice |
| Placebo | Placebo comparator | ingestion of placebo before an exercise session. Receives: Other: Exercise; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Every 15 minutes during 24 hours from 60 minutes after exercise
Secondary outcomes (3)
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.
Measured: During the 20 minutes before and after the exercise and during the execution of the exercise.
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.
Measured: Before supplementation, right after, 60 minutes and 24 hour after exercise sessions
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.
Measured: Every 15 minutes during 24 hours from 60 minutes after exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2018
- Study start1 Feb 2018
- Primary completion1 Aug 2018
- Study completion11 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Federal University of Uberlandia
- Sponsor type
- University, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Responsible party
- Principal investigator, Ana Luiza Amaral Ribeiro, Federal University of Uberlandia
- Investigators
- Guilherme M Guilherme, Phd, Principal investigator, Federal University of Uberlandia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03620227
- Sponsor's protocol ID
- CEP UFU 70104717.0.0000.5152
- Status last verified
- Feb 2019
- First submitted
- 8 May 2018
- Last updated
- 20 Feb 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Beetroot Juice Supplementation in Response to Physical Exercise in Postmenopausal and Hypertensive Women
- ClinicalTrials.gov ID
- NCT03620227
- Acronym / sponsor ID
- CEP UFU 70104717.0.0000.5152
- Conditions
- Hypertension, Menopause
- Keywords
- Combined Exercise, Beetroot juice, Women health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Federal University of UberlandiaUniversity, hospital or other
- Collaborators
- Conselho Nacional de Desenvolvimento Científico e Tecnológico, Fundação de Amparo à Pesquisa do estado de Minas Gerais
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 11 Feb 2019 (actual)
- First posted
- 8 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice | Experimental | Other: Exercise, Dietary Supplement: Beetroot juiceingestion of beetroot juice before an exercise session. |
| Placebo | Placebo comparator | Other: Exercise, Dietary Supplement: Placeboingestion of placebo before an exercise session. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (9 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseAlso: Exercise session40 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. | Other | Beetroot juice, Placebo |
| Beetroot juiceIngestion of 350ml of concentrated beetroot juice (400mg of nitrate) 100 minutes before an exercise session. | Dietary supplement | Beetroot juice |
| PlaceboIngestion of 350ml of placebo (0mg of nitrate, with the same color, taste and smell) 100 minutes before an exercise session. | Dietary supplement | Placebo |
Primary outcome
Changes in rest Blood Pressure
Time frame: Before and 15, 30, 45 and 60 minutes after exercise sessions
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.
Changes in Ambulatorial Blood Pressure
Time frame: Every 15 minutes during 24 hours from 60 minutes after exercise
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.
3 secondary outcomes
Changes in Heart Rate Variability
Time frame: During the 20 minutes before and after the exercise and during the execution of the exercise.
Changes in salivary oxidative stress
Time frame: Before supplementation, right after, 60 minutes and 24 hour after exercise sessions
Changes in Ambulatorial Blood Pressure Variability
Time frame: Every 15 minutes during 24 hours from 60 minutes after exercise
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guilherme M Guilherme, Phd principal investigator
Federal University of Uberlandia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise and Beetroot juice in people with Hypertension and Menopause, run by Federal University of Uberlandia at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in rest Blood Pressure (time frame: Before and 15, 30, 45 and 60 minutes after exercise sessions). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2019.