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

NCT ID: NCT05294198

Last Updated: 2022-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-10
• Study Completion Date: 2021-11-12

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.

Conditions

Healthy Males

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Beet protocol

Beta vulgaris L. extract (600mg)

Group Type: EXPERIMENTAL

Beetroot extract

Intervention Type: DIETARY_SUPPLEMENT

Beetroot extract capsule

Placebo protocol

Starch (600mg)

Group Type: PLACEBO_COMPARATOR

Beetroot extract

Intervention Type: DIETARY_SUPPLEMENT

Beetroot extract capsule

Interventions

Beetroot extract

Beetroot extract capsule

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Pernambuco

OTHER

Sponsor Role: lead

Responsible Party

Cicero Jonas R Benjamim

Nutritionist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cicero Benjamim, nutricionist

Role: PRINCIPAL_INVESTIGATOR

University of Pernambuco

Locations

University of Pernambuco

Petrolina, Pernambuco, Brazil

Countries

Brazil

Other Identifiers

PX086

Identifier Type: -

Identifier Source: org_study_id