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

Healthy Males Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05294198
• Other study ID #: PX086
• Status: Completed
• Phase: N/A
• Start date: May 10, 2021
• Est. completion date: November 12, 2021

Study information

• Verified date: March 2022
• Source: University of Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 30 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy Males

Intervention

Dietary Supplement:
• Beetroot extract
Beetroot extract capsule

Locations

Country	Name	City	State
Brazil	University of Pernambuco	Petrolina	Pernambuco

Sponsors (1)

Lead Sponsor	Collaborator
University of Pernambuco

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability values (milliseconds)		Through study completion, an average of 1 year
Secondary	Systolic and diastolic blood pressure values (mmHg)		Through study completion, an average of 1 year
Secondary	Heart rate values (beats per minute)		Through study completion, an average of 1 year