NCT01795534

Brief Summary

The study will aim to describe and evaluate the effect of beetroot juice supplementation upon whole body running exercise at altitude. It is hypothesised that beetroot supplementation will decrease time to complete a 10 km time trial.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

February 1, 2013

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 20, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

April 6, 2015

Completed
Last Updated

July 19, 2017

Status Verified

March 1, 2015

Enrollment Period

7 months

First QC Date

February 18, 2013

Results QC Date

June 16, 2014

Last Update Submit

June 20, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Time to Complete a 10 km Run

    Time taken following consumption of beetroot shot or consumption of placebo shot

    Period 1 (on day of 1st intervention) and period 2 (on day of 2nd intervention)

Study Arms (2)

Beetroot shot then placebo shot

EXPERIMENTAL

Intervention: Participants will first consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK). Following a four day wash out, participants will then consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK)

Dietary Supplement: Beetroot shot then placebo shot

Placebo shot then beetroot shot

PLACEBO COMPARATOR

Intervention: Participants will first consume a Nitrate-depleted beetroot shot: 1x70ml nitrate-depleted beetroot Placebo shot (\~0.003mmol of nitrate)(Beet It, James White Drinks Ltd, Ipswich, UK). Following a four day wash out, participants will then consume a Beetroot shot: 1x70ml concentrated NO-3 shot of rich Beetroot juice (\~7mmol nitrate) (Beet It, James White Drinks Ltd, Ipswich, UK).

Dietary Supplement: Placebo shot then beetroot shot

Interventions

Beetroot shot, four day wash out, then placebo shot

Beetroot shot then placebo shot

Placebo shot, four day wash out, then beetroot shot

Placebo shot then beetroot shot

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Trained athletes with personal best performances for a 10km run of sub 40 minutes

You may not qualify if:

  • \- Unable to give informed consent Unstable medical condition.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bangor University

Bangor, Gwynedd, LL57 2PZ, United Kingdom

Location

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Dr Jamie Macdonald
Organization
Bangor University

Study Officials

  • Jamie H Macdonald, PhD

    Bangor University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2013

First Posted

February 20, 2013

Study Start

February 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

July 19, 2017

Results First Posted

April 6, 2015

Record last verified: 2015-03

Locations