Beetroot Extract and Its Influence on Cardiovascular and... | NCT05294198

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

NCT05294198

Sponsor

University of Pernambuco

Status

Completed

Last Update Posted

Mar 24, 2022Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Healthy Males

Interventions

Beetroot extract

Countries

Brazil

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 10, 2021Actual

Primary Completion Date

Nov 12, 2021Actual

Completion Date

Nov 12, 2021Actual

First Submitted Date

Mar 4, 2022

First Submission Date that Met QC Criteria

Mar 14, 2022

First Posted Date

Mar 24, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2022

Last Update Posted Date

Mar 24, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Yes

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Beet protocol	Experimental	Beta vulgaris L. extract (600mg)	Dietary Supplement: Beetroot extract
Placebo protocol	Placebo Comparator	Starch (600mg)	Dietary Supplement: Beetroot extract

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beetroot extract	Dietary Supplement	Beetroot extract capsule	Beet protocol Placebo protocol

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

30 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Cicero Benjamim, nutricionist	University of Pernambuco	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Pernambuco		Petrolina	Pernambuco	56328-900	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided