- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04094233
Acute Effects of Beet Extract on Autonomic and Cardiovascular Recovery After Exercise
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Pernambuco
-
Petrolina, Pernambuco, Brazil, 56328-900
- Cicero Jonas R Benjamim
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Beetroot Extract
Capsule containing 600mg of beetroot extract.
|
Ingestion of 600mg beetroot extract two hours before strength exercise (75% 1RM).
Ingestion of 600mg starch two hours before strength exercise (75% 1RM).
|
EXPERIMENTAL: Placebo
Capsule containing 600mg of starch.
|
Ingestion of 600mg beetroot extract two hours before strength exercise (75% 1RM).
Ingestion of 600mg starch two hours before strength exercise (75% 1RM).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Beetroot extract effects on heart rate variability (based on frequency and time domain)
Time Frame: up to 1 year
|
up to 1 year
|
|
Blood pressure (mmHg)
Time Frame: up to 1 year
|
Beetroot extract effects blood pressure recovery following strength exercise
|
up to 1 year
|
Heart rate (beats per minute)
Time Frame: up to 1 year
|
Beetroot effects heart rate recovery following strength exercise
|
up to 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UPernambuco14-09
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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