Effect of Beetroot Juice Supplements on Lower-limb Streng... | NCT04987619

Studies
Effect of Beetroot Juice Supplements on Lower-limb Strength in Females

NCT04987619

Sponsor

Maimónides Biomedical Research Institute of Córdoba

Status

Completed

Last Update Posted

Aug 31, 2021Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Muscular Endurance

Interventions

Beetroot juice
Capri-Sun

Countries

Brazil
Spain

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

Jul 2021

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

Jul 5, 2021Actual

Primary Completion Date

Aug 29, 2021Actual

Completion Date

Aug 29, 2021Actual

First Submitted Date

Jul 20, 2021

First Submission Date that Met QC Criteria

Aug 2, 2021

First Posted Date

Aug 3, 2021Actual

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

Aug 30, 2021

Last Update Posted Date

Aug 31, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study aims to evaluate the effects of beetroot juice supplements on lower-limb strength and muscular endurance in physically active women, due to the presence of NO3- in beetroot juice.

Detailed Description

Beetroot juice (BJR) is used as an ergogenic aid, but no study has analyzed its' effects on explosive force production in physically active women. It has been proposed that females could blunt reduction of NO2- to NO based on a higher oxidative skeletal muscle phenotype than males. However, it has been observed a higher increase on plasma NO2- levels after supplementation compared to and a greater enhancement on muscle contractile function.

Based on the absence of any study that has analyzed the effect of NO3- supplements on jump ability and power production on weightlifting on female population; the purpose of this study will be to investigate the possible ergogenic effect of BJR on physically active women on explosive force production and muscular endurance in a lower-limb body weightlifting protocol, due to the presence of NO3- in BJR and its effects.

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

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
BJR	Experimental	70 mL of beetroot juice (BEET It Sport®; James White Drinks Ltd., Ipswich, UK)	Dietary Supplement: Beetroot juice
PLA	Placebo Comparator	70 mL of blackcurrant beverage Capri-Sun.	Other: Capri-Sun

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Beetroot juice	Dietary Supplement	Subjects will drink juice 120 minutes before each visit	BJR

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of height reached in jump	Evaluated through CMJ (Counter movement jump) test with a recovery period of 45 seconds between jumps.	Week 1, 2 and 3.

Secondary Outcomes

Measure	Description	Time Frame
Movement velocity	Evaluated at 50% and 75% repetition maximum (RM)	Visit 1 (week 1), 2 (week 2) and 3 (week 3).
Power on back squat	Evaluated at 50% and 75% repetition maximum (RM)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Physically active females with 18-30 years of age
More than 6 months on RT training programs
Be familiarized with back squat, leg press and leg extension exercises
Not consuming any type of nutritional supplement or anabolic substances in the previous three months or during the study
Not suffering from a musculoskeletal injury that could interfere with the exercise protocol during the investigation

Exclusion Criteria:

None

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Gender identity

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
Jose Manuel Jurado Castro	Hospital General Universitario Reina Sofía de Murcia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Studies Research Group in Neuromuscular Responses (GEPREN), University of Lavras		Lavras		37200-000	Brazil

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Data will be shared after the study concludes and results are published

Types

Not provided

Time Frame

After results are published

Access Criteria

Upon request to study's principal investigator

URL

Not provided

Intervention Model Description

The experimental procedure will consist of three visits, separate from each other by one week, to achieve the total elimination of any effects caused by BJR as well as the optimal recovery of the participants.

Masking Info

Masking

Double

Masking Description

The order in which the participants will consume one supplement or another will be assigned randomly and double blind by an external collaborator to the research team, who will be responsible for coding the bottles.

Who Masked

ParticipantInvestigator