Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males

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.

Study Overview

• Status: Completed
• Conditions: Healthy Males
• Intervention / Treatment: Dietary supplement: Beetroot extract

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Pernambuco
    • Petrolina, Pernambuco, Brazil, 56328-900
      • University of Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Healthy males;
• Physically active according to International Physical Activity Questionnaire (IPAQ);
• 18 to 30 old years.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beet protocol; Beta vulgaris L. extract (600mg)	Dietary supplement: Beetroot extract; Beetroot extract capsule
Placebo Comparator: Placebo protocol; Starch (600mg)	Dietary supplement: Beetroot extract; Beetroot extract capsule

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Heart rate variability values (milliseconds)	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Pernambuco
• Investigators: Principal Investigator: Cicero Benjamim, nutricionist, University of Pernambuco

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): November 12, 2021
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: March 4, 2022
• First Submitted That Met QC Criteria: March 14, 2022
• First Posted (Actual): March 24, 2022

Study Record Updates

• Last Update Posted (Actual): March 24, 2022
• Last Update Submitted That Met QC Criteria: March 14, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: PX086

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes