Does Dietary Nitrate Supplementation Improve Aerobic Performance

Colorectal Cancer Clinical Trial

Official title:

Does Dietary Nitrate Supplementation Improve Aerobic Performance in Colorectal Cancer? A Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02319356
• Other study ID #: 163841
• Status: Not yet recruiting
• Phase: Phase 0
• First received: December 15, 2014
• Last updated: December 17, 2014
• Start date: March 2015
• Est. completion date: June 2015

Study information

• Verified date: December 2014
• Source: Royal Surrey County Hospital NHS Foundation Trust
• Contact: Vanessa Brown, MBBS, MRCS
• Phone: 00441483688691
• Email: vanessabrown[@]doctors.org.uk
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine whether dietary nitrate supplementation improves performance in cardiopulmonary exercise testing (CPET).

Description:

Dietary nitrate supplementation has been shown to enhance exercise tolerance and performance in professional athletes and physically active males.

Cardiopulmonary exercise testing (CPET) is an established, non invasive and safe method of assessing patients' cardiopulmonary reserve prior to surgery. It has been shown to predict complications and length of stay in patients undergoing major elective surgery.

The anaerobic threshold (AT), the oxygen uptake at which anaerobic ATP synthesis supplements aerobic ATP synthesis and the maximal oxygen uptake (VO2max) the point where the oxygen uptake plateaus despite an increase in work rate; both calculated during CPET; have both been shown to predict short and long term outcomes after surgery and postoperative complications.

We aim to study the effect of dietary nitrate supplementation on CPET results in patients awaiting surgery for colorectal cancer.

Our primary outcome will be the change in the AT and VO2Max after beetroot juice supplementation.

Methods: Patients will undergo an initial CPET and will then be randomized to receive either beetroot juice (BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk) or 'placebo' (PL, NO3-depleted beetroot juice) for 7 days. A second CPET will then be performed.

This pilot study will be used to calculate the mean AT and VO2Max and associated standard deviations for our population and the approximate effect of BRJ on them.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: June 2015
• Est. primary completion date: June 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective Colonic or rectal resection.

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• Beetroot juice
(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk)
• Placebo beetroot juice
(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Royal Surrey County Hospital NHS Foundation Trust

References & Publications (3)

Colson 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. — View Citation

Jones AM. Dietary nitrate supplementation and exercise performance. Sports Med. 2014 May;44 Suppl 1:S35-45. doi: 10.1007/s40279-014-0149-y. Review. — View Citation

Snowden 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	anaerobic threshold (AT)	The change in the anaerobic threshold (AT) after beetroot juice supplementation.	1 year	No
Primary	maximal oxygen uptake (VO2Max)	The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.	1 year	No