Ignite Creation Date:
2025-12-25 @ 2:46 AM
Ignite Modification Date:
2026-03-05 @ 2:38 PM
Study NCT ID:
NCT04094233
Status:
COMPLETED
Last Update Posted:
2020-03-27
First Post:
2019-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Effects of Beet Extract on Autonomic and Cardiovascular Recovery After Exercise
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2020-03-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-03-25', 'studyFirstSubmitDate': '2019-09-15', 'studyFirstSubmitQcDate': '2019-09-16', 'lastUpdatePostDateStruct': {'date': '2020-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beetroot extract effects on heart rate variability (based on frequency and time domain)', 'timeFrame': 'up to 1 year'}, {'measure': 'Blood pressure (mmHg)', 'timeFrame': 'up to 1 year', 'description': 'Beetroot extract effects blood pressure recovery following strength exercise'}, {'measure': 'Heart rate (beats per minute)', 'timeFrame': 'up to 1 year', 'description': 'Beetroot effects heart rate recovery following strength exercise'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Beetroot', 'Heart rate variability', 'Blood pressure', 'Strenght Exercise'], 'conditions': ['Cardiovascular Diseases', 'Prevention']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nFrom 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.\n\nResearch 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.\n\nParticipants' 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.\n\nResistance 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).\n\nLeg 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"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '28 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI) within the range of Eutrophy (18.5 to 24.9kg / m²)\n* Experience with resistance training, uninterrupted for at least 3 months and weekly frequency of 3 sessions or more\n* Do not use any medication that may interfere with cardiac autonomic modulation\n* Do have no skeletal muscle damage.\n\nExclusion Criteria:\n\n* Smoking patients\n* As well as individuals who have already used anabolic steroids\n* Cardiorespiratory diseases\n* Neurological disorders\n* Other known compromises that prevent the subject from performing the procedures.'}, 'identificationModule': {'nctId': 'NCT04094233', 'briefTitle': 'Acute Effects of Beet Extract on Autonomic and Cardiovascular Recovery After Exercise', 'organization': {'class': 'OTHER', 'fullName': 'University of Pernambuco'}, 'officialTitle': 'Acute Effects of Beet Extract on Autonomic and Cardiovascular Recovery After Exercise', 'orgStudyIdInfo': {'id': 'UPernambuco14-09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beetroot Extract', 'description': 'Capsule containing 600mg of beetroot extract.', 'interventionNames': ['Dietary Supplement: Beetroot extract', 'Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo', 'description': 'Capsule containing 600mg of starch.', 'interventionNames': ['Dietary Supplement: Beetroot extract', 'Other: Placebo']}], 'interventions': [{'name': 'Beetroot extract', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Ingestion of 600mg beetroot extract two hours before strength exercise (75% 1RM).', 'armGroupLabels': ['Beetroot Extract', 'Placebo']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Ingestion of 600mg starch two hours before strength exercise (75% 1RM).', 'armGroupLabels': ['Beetroot Extract', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '56328-900', 'city': 'Petrolina', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Cicero Jonas R Benjamim', 'geoPoint': {'lat': -9.39861, 'lon': -40.50083}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pernambuco', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Cicero Jonas R Benjamim', 'investigatorAffiliation': 'University of Pernambuco'}}}}