Cardiovascular DiseasesNCT04094233
Acute Effects of Beet Extract on Autonomic and Cardiovascular Recovery After Exercise
A study testing Beetroot extract in people with Cardiovascular Diseases and Prevention, run by University of Pernambuco at 1 site in Brazil.
Trial summary
Dietary NO3 is found in high concentrations in green leafy vegetables and beets. Studies weighing the action of NO3 for ergogenic purposes have found metabolic improvement in skeletal muscle during exercise in hypoxia, lowering blood pressure and increased workload at anaerobic threshold. Read more about this study
- Who is it for?
- Ages 18 to 28 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Prevention
- What is being tested?
- Beetroot extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Oct 2019to 23 Mar 2020
- 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 18 to 28 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Body Mass Index (BMI) within the range of Eutrophy (18.5 to 24.9kg / m²)
- Experience with resistance training, uninterrupted for at least 3 months and weekly frequency of 3 sessions or more
- Do not use any medication that may interfere with cardiac autonomic modulation
- Do have no skeletal muscle damage.
Who cannot join
- Smoking patients
- As well as individuals who have already used anabolic steroids
- Cardiorespiratory diseases
- Neurological disorders
- Other known compromises that prevent the subject from performing the procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Dietary NO3 is found in high concentrations in green leafy vegetables and beets. Studies weighing the action of NO3 for ergogenic purposes have found metabolic improvement in skeletal muscle during exercise in hypoxia, lowering blood pressure and increased workload at anaerobic threshold. In a way, the use of nitrate in combination with exercise may assist in autonomic adaptation to multiple stimuli, such as rest, during exercise and during the recovery period. HRV is one of the most practical methods for analyzing the physiological functioning of the ANS, both in the pathological condition of the individual and in the induction of other variables. peak-R (RRI) of consecutive heart beats. This study aims to evaluate the effect of beet extract supplementation in combination with submaximal strength exercise on heart rate variability and cardiovascular parameters of physically active individuals. It is a double-blind randomized crossover clinical trial.
Read the detailed description
An anamnesis of the participants will be made before the research. Essential information such as name, gender, age, height, BMI will be collected. Anthropometric measurements will be acquired according to the recommendations. Volunteers will be properly informed about the procedures and objectives of this study.
From a pre-established randomization, on the first day of collection volunteers will be allocated to group I (Placebo) or group II (Beet Extract). In the first intervention the volunteers allocated in group I will take a capsule containing 600mg of starch, at the end of this will be provided another capsule containing 600mg of beet extract for the second intervention. Conversely, group II volunteers will ingest a capsule containing 600mg of beet extract in the first intervention, and at the end of the experiment, another capsule containing 600mg of starch will be provided.
Research participants will be advised to consume the capsules within 2 hours of the procedure, adequate time for digestion, absorption and effect on the body. Prior to testing will be asked about the use of caffeine or any other type of substance that is described in the study inclusion and exclusion criteria. Then the collection will proceed.
Participants' blood pressure will be measured before (Rest) and after submaximal strength exercise during the first recovery time (REC1- 00-05 minutes) at 5 1-minute intervals using an aneroid sphygmomanometer (Premium®). and stethoscope (Rappaport®). Korotkoff's first and fifth phase readings were adopted as systolic and diastolic blood pressure, respectively.
Resistance exercise will be performed by performing movements that recruit lower limbs, emphasizing the quadriceps, posterior leg and buttocks. Training intensity will be defined by a subjective test of 1 repetition maximum (1RM). The evaluation will take place at a time before (at least 72 hours) to the data collection, aiming to pre-define and standardize the load that will be used on the day of the experiment. In this sense, the individuals will be oriented to test the load in the 4 proposed physical exercises in a total of 10 maximum repetitions, obtaining 75% of 1 maximum repetition (75% 1RM).
Leg Press 45º - 4 sets x 10 repetitions (75% 1RM) Extender Chair - 4 sets x 10 reps (75% 1RM) Abductor Chair - 4 sets x 10 repetitions (75% 1RM) Guided Squat - 4 sets x 10 repetitions (75% 1RM
- Conditions
- Cardiovascular Diseases, Prevention
- Being tested
- Beetroot extract, Placebo
- Keywords
- Beetroot, Heart rate variability, Blood pressure, Strenght Exercise
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot extractDietary supplement
Ingestion of 600mg beetroot extract two hours before strength exercise (75% 1RM).
PlaceboOther
Ingestion of 600mg starch two hours before strength exercise (75% 1RM).
| Study group | Role | What they receive |
|---|---|---|
| Beetroot Extract | Experimental | Capsule containing 600mg of beetroot extract. Receives: Dietary Supplement: Beetroot extract; Other: Placebo |
| Placebo | Experimental | Capsule containing 600mg of starch. Receives: Dietary Supplement: Beetroot extract; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Beetroot extract effects on heart rate variability (based on frequency and time domain)
Measured: up to 1 year
Blood pressure (mmHg)
Beetroot extract effects blood pressure recovery following strength exercise
Measured: up to 1 year
Heart rate (beats per minute)
Beetroot effects heart rate recovery following strength exercise
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2019
- Study start1 Oct 2019
- Primary completion15 Feb 2020
- Study completion23 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pernambuco
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cicero Jonas R Benjamim, University of Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04094233
- Sponsor's protocol ID
- UPernambuco14-09
- Status last verified
- Mar 2020
- First submitted
- 15 Sep 2019
- Last updated
- 27 Mar 2020
- 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 27 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Beet Extract on Autonomic and Cardiovascular Recovery After Exercise
- ClinicalTrials.gov ID
- NCT04094233
- Acronym / sponsor ID
- UPernambuco14-09
- Conditions
- Cardiovascular Diseases, Prevention
- Keywords
- Beetroot, Heart rate variability, Blood pressure, Strenght Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PernambucoUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 18 Sep 2019 (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.
Dietary NO3 is found in high concentrations in green leafy vegetables and beets. Studies weighing the action of NO3 for ergogenic purposes have found metabolic improvement in skeletal muscle during exercise in hypoxia, lowering blood pressure and increased workload at anaerobic threshold. In a way, the use of nitrate in combination with exercise may assist in autonomic adaptation to multiple stimuli, such as rest, during exercise and during the recovery period. HRV is one of the most practical methods for analyzing the physiological functioning of the ANS, both in the pathological condition of the individual and in the induction of other variables. peak-R (RRI) of consecutive heart beats. This study aims to evaluate the effect of beet extract supplementation in combination with submaximal strength exercise on heart rate variability and cardiovascular parameters of physically active individuals. It is a double-blind randomized crossover clinical trial.
Detailed description
An anamnesis of the participants will be made before the research. Essential information such as name, gender, age, height, BMI will be collected. Anthropometric measurements will be acquired according to the recommendations. Volunteers will be properly informed about the procedures and objectives of this study.
From a pre-established randomization, on the first day of collection volunteers will be allocated to group I (Placebo) or group II (Beet Extract). In the first intervention the volunteers allocated in group I will take a capsule containing 600mg of starch, at the end of this will be provided another capsule containing 600mg of beet extract for the second intervention. Conversely, group II volunteers will ingest a capsule containing 600mg of beet extract in the first intervention, and at the end of the experiment, another capsule containing 600mg of starch will be provided.
Research participants will be advised to consume the capsules within 2 hours of the procedure, adequate time for digestion, absorption and effect on the body. Prior to testing will be asked about the use of caffeine or any other type of substance that is described in the study inclusion and exclusion criteria. Then the collection will proceed.
Participants' blood pressure will be measured before (Rest) and after submaximal strength exercise during the first recovery time (REC1- 00-05 minutes) at 5 1-minute intervals using an aneroid sphygmomanometer (Premium®). and stethoscope (Rappaport®). Korotkoff's first and fifth phase readings were adopted as systolic and diastolic blood pressure, respectively.
Resistance exercise will be performed by performing movements that recruit lower limbs, emphasizing the quadriceps, posterior leg and buttocks. Training intensity will be defined by a subjective test of 1 repetition maximum (1RM). The evaluation will take place at a time before (at least 72 hours) to the data collection, aiming to pre-define and standardize the load that will be used on the day of the experiment. In this sense, the individuals will be oriented to test the load in the 4 proposed physical exercises in a total of 10 maximum repetitions, obtaining 75% of 1 maximum repetition (75% 1RM).
Leg Press 45º - 4 sets x 10 repetitions (75% 1RM) Extender Chair - 4 sets x 10 reps (75% 1RM) Abductor Chair - 4 sets x 10 repetitions (75% 1RM) Guided Squat - 4 sets x 10 repetitions (75% 1RM
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot Extract | Experimental | Dietary Supplement: Beetroot extract, Other: PlaceboCapsule containing 600mg of beetroot extract. |
| Placebo | Experimental | Dietary Supplement: Beetroot extract, Other: PlaceboCapsule containing 600mg of starch. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Body Mass Index (BMI) within the range of Eutrophy (18.5 to 24.9kg / m²)
- Experience with resistance training, uninterrupted for at least 3 months and weekly frequency of 3 sessions or more
- Do not use any medication that may interfere with cardiac autonomic modulation
- Do have no skeletal muscle damage.
Key exclusion criteria (5 listed)
- Smoking patients
- As well as individuals who have already used anabolic steroids
- Cardiorespiratory diseases
- Neurological disorders
- Other known compromises that prevent the subject from performing the procedures.
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 |
|---|---|---|
| Beetroot extractIngestion of 600mg beetroot extract two hours before strength exercise (75% 1RM). | Dietary supplement | Beetroot Extract, Placebo |
| PlaceboIngestion of 600mg starch two hours before strength exercise (75% 1RM). | Other | Beetroot Extract, Placebo |
Primary outcome
Beetroot extract effects on heart rate variability (based on frequency and time domain)
Time frame: up to 1 year
Blood pressure (mmHg)
Time frame: up to 1 year
Beetroot extract effects blood pressure recovery following strength exercise
Heart rate (beats per minute)
Time frame: up to 1 year
Beetroot effects heart rate recovery following strength 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 27 Mar 2020.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beetroot extract in people with Cardiovascular Diseases and Prevention, run by University of Pernambuco 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 4 inclusion and 5 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 27 Mar 2020. 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. 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?
Beetroot extract effects on heart rate variability (based on frequency and time domain) (time frame: up to 1 year). The study lists 3 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 27 Mar 2020.