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

Sponsor
University of Pernambuco (Other)
Overall Status
Completed
CT.gov ID
NCT05294198
Collaborator
(none)
16
Enrollment
1
Location
2
Arms
6.1
Actual Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Beetroot extract
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
16 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Prevention
Official Title:
Beetroot Extract and Its Influence on Cardiovascular and Autonomic Recovery From the Effort in Healthy Males
Actual Study Start Date :
May 10, 2021
Actual Primary Completion Date :
Nov 12, 2021
Actual Study Completion Date :
Nov 12, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Heart rate variability values (milliseconds) [Through study completion, an average of 1 year]

Secondary Outcome Measures

  1. Systolic and diastolic blood pressure values (mmHg) [Through study completion, an average of 1 year]

  2. Heart rate values (beats per minute) [Through study completion, an average of 1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Pernambuco Petrolina Pernambuco Brazil 56328-900

Sponsors and Collaborators

  • University of Pernambuco

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cicero Jonas R Benjamim, Nutritionist, University of Pernambuco
ClinicalTrials.gov Identifier:
NCT05294198
Other Study ID Numbers:
  • PX086
First Posted:
Mar 24, 2022
Last Update Posted:
Mar 24, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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

Study Results

No Results Posted as of Mar 24, 2022