Does Dietary Nitrate Supplementation Improve Aerobic Performance

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

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

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Dietary supplement: Beetroot juice; Dietary supplement: Placebo beetroot juice

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Early Phase 1

Contacts and Locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Beetroot juice (BRJ); beetroot juice	Dietary supplement: Beetroot juice; (BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk); Other Names: Beet it Sport Shots
Placebo Comparator: Placebo (PL); placebo juice	Dietary supplement: Placebo beetroot juice; (PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk); Other Names: Nitrate deplete Beet it Sport Shots

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Royal Surrey County Hospital NHS Foundation Trust
• Investigators: Principal Investigator: Vanessa Brown, MBBS, MRCS, Royal Surrey County Hospital Guildford

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): June 1, 2015
• Study Completion (Anticipated): June 1, 2015

Study Registration Dates

• First Submitted: December 15, 2014
• First Submitted That Met QC Criteria: December 17, 2014
• First Posted (Estimate): December 18, 2014

Study Record Updates

• Last Update Posted (Estimate): December 18, 2014
• Last Update Submitted That Met QC Criteria: December 17, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms
• Other Study ID Numbers: 163841