NCT03449992

Brief Summary

This study analyzed the effects of 15 days of beetroot juice supplementation on different performance measures in elite Spanish distance runners

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2017

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2017

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 19, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 1, 2018

Completed
Last Updated

March 1, 2018

Status Verified

February 1, 2018

Enrollment Period

2 months

First QC Date

February 19, 2018

Last Update Submit

February 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Running economy

    The cost of running (oxygen consumption) at different speeds

    Changes from baseline at 15 days

Secondary Outcomes (5)

  • Time to exhaustion

    Changes from baseline at 15 days

  • Muscle power

    Changes from baseline at 15 days

  • Muscle oxygenation

    Changes from baseline at 15 days

  • RPE

    Changes from baseline at 15 days

  • Running mechanics

    Changes from baseline at 15 days

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in this group ingested nitrate-rich beetroot juice for 15 days

Dietary Supplement: nitrate-rich beetroot juice

Placebo group

PLACEBO COMPARATOR

Participants in this group ingested a placebo drink for 15 days

Dietary Supplement: Placebo

Interventions

nitrate-rich beetroot juiceDIETARY_SUPPLEMENT

Nitrate-rich beetroot juice supplementation was administered for 15 consecutive days to participants in this arm

Also known as: Beetroot juice
Intervention group
PlaceboDIETARY_SUPPLEMENT

Placebo drink

Placebo group

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Competing in national and international events
  • Personal best in urban 10k: 33 minutes 0 seconds

You may not qualify if:

  • Injury

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Carlos Balsalobre-Fernández, PhD

    Universidad Autonoma de Madrid

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Twelve participants were randomly assigned to either an intervention group or a placebo group, and a 4 digits code based on their Spanish ID card were used to code their names. Then, an independent researcher prepared individual bags with either a 15-days worth of placebo drinks or beetroot drinks, and gave it to the athletes. Then, this person was withdrawn for the research procedures. Finally, another group of researchers, without knowing what athlete was on each group (intervention or placebo), conducted the performance tests pre and post 15 days of supplementation, and another group analyzed the data once collected.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Twelve elite distance runners were randomly assigned to either an intervention group or a placebo group. Participants in each group consumed beetroot juice or a placebo drink for 15 consecutive days.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2018

First Posted

March 1, 2018

Study Start

November 1, 2016

Primary Completion

January 10, 2017

Study Completion

November 15, 2017

Last Updated

March 1, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Coded database with data of the pre-post measures will be made available

Shared Documents
ANALYTIC CODE
Time Frame
Indefinitely available
Access Criteria
Open access
More information

Available IPD Datasets

Individual Participant Data Set Access