Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males
1 other identifier
interventional
16
1 country
1
Brief Summary
There is no evidence that beetroot extract (Beta vulgaris L.) is advantageous for the recovery of cardiovascular parameters and the autonomic nervous system (ANS) after submaximal aerobic exercise. The objective of this study is to evaluate the effect of beetroot extract supplementation on the recovery of cardiorespiratory and autonomic parameters after a submaximal aerobic exercise session. Healthy male adults will perform a cross-over, randomized, double-blind, and placebo-controlled trial. Beetroot extract (600mg) or placebo (600mg) will be ingested 90 minutes before evaluation in randomized days. Systolic blood pressure (SBP), diastolic blood pressure (DBP), pulse pressure (PP), mean arterial pressure (MAP), heart rate (HR), and HR variability (HRV) indexes will be recorded at Rest and during 60 minutes of recovery from exercise.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started May 2021
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 12, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 12, 2021
CompletedFirst Submitted
Initial submission to the registry
March 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 24, 2022
CompletedMarch 24, 2022
March 1, 2022
6 months
March 4, 2022
March 14, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Heart rate variability values (milliseconds)
Through study completion, an average of 1 year
Secondary Outcomes (2)
Systolic and diastolic blood pressure values (mmHg)
Through study completion, an average of 1 year
Heart rate values (beats per minute)
Through study completion, an average of 1 year
Study Arms (2)
Beet protocol
EXPERIMENTALBeta vulgaris L. extract (600mg)
Placebo protocol
PLACEBO COMPARATORStarch (600mg)
Interventions
Eligibility Criteria
You may qualify if:
- Healthy males;
- Physically active according to International Physical Activity Questionnaire (IPAQ);
- to 30 old years.
You may not qualify if:
- Body mass index BMI \<18.5kg/m² and \>29.9kg/m²;
- Smokers;
- Subjects undergoing pharmacotherapies;
- Musculoskeletal, metabolic, renal diseases;
- Root mean squared standard deviation of R-R intervals \<15 milliseconds.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Pernambuco
Petrolina, Pernambuco, 56328-900, Brazil
Study Officials
- PRINCIPAL INVESTIGATOR
Cicero Benjamim, nutricionist
University of Pernambuco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nutritionist
Study Record Dates
First Submitted
March 4, 2022
First Posted
March 24, 2022
Study Start
May 10, 2021
Primary Completion
November 12, 2021
Study Completion
November 12, 2021
Last Updated
March 24, 2022
Record last verified: 2022-03