Does Dietary Nitrate Supplementation Improve Aerobic Performance
1 other identifier
interventional
70
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether dietary nitrate supplementation improves performance in cardiopulmonary exercise testing (CPET).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 colorectal-cancer
Started Mar 2015
Shorter than P25 for early_phase_1 colorectal-cancer
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
First Submitted
Initial submission to the registry
December 15, 2014
CompletedFirst Posted
Study publicly available on registry
December 18, 2014
CompletedStudy Start
First participant enrolled
March 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedDecember 18, 2014
December 1, 2014
3 months
December 15, 2014
December 17, 2014
Conditions
Outcome Measures
Primary Outcomes (2)
anaerobic threshold (AT)
The change in the anaerobic threshold (AT) after beetroot juice supplementation.
1 year
maximal oxygen uptake (VO2Max)
The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.
1 year
Study Arms (2)
Beetroot juice (BRJ)
ACTIVE COMPARATORbeetroot juice
Placebo (PL)
PLACEBO COMPARATORplacebo juice
Interventions
(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk)
(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk)
Eligibility Criteria
You may qualify if:
- Elective Colonic or rectal resection.
You may not qualify if:
- Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction, inability to perform CPET
- Inability to give informed consent
- Emergency surgery
- During CPET: Ischemic ECG or inability to reach AT
- Allergy to Beetroot
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (3)
Jones AM. Dietary nitrate supplementation and exercise performance. Sports Med. 2014 May;44 Suppl 1(Suppl 1):S35-45. doi: 10.1007/s40279-014-0149-y.
PMID: 24791915BACKGROUNDSnowden CP, Prentis JM, Anderson HL, Roberts DR, Randles D, Renton M, Manas DM. Submaximal cardiopulmonary exercise testing predicts complications and hospital length of stay in patients undergoing major elective surgery. Ann Surg. 2010 Mar;251(3):535-41. doi: 10.1097/SLA.0b013e3181cf811d.
PMID: 20134313BACKGROUNDColson M, Baglin J, Bolsin S, Grocott MP. Cardiopulmonary exercise testing predicts 5 yr survival after major surgery. Br J Anaesth. 2012 Nov;109(5):735-41. doi: 10.1093/bja/aes263. Epub 2012 Aug 21.
PMID: 22910977BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Vanessa Brown, MBBS, MRCS
Royal Surrey County Hospital Guildford
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Responsible research fellow
Study Record Dates
First Submitted
December 15, 2014
First Posted
December 18, 2014
Study Start
March 1, 2015
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 18, 2014
Record last verified: 2014-12