Does Dietary Nitrate Supplementation Improve Aerobic Performance

Early Phase 1

• Conditions: Colorectal Cancer
• Interventions: Dietary Supplement: Beetroot juice; Dietary Supplement: Placebo beetroot juice

• Registration Number: NCT02319356
• Lead Sponsor: Royal Surrey County Hospital NHS Foundation Trust

Brief Summary

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

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 Timeline

• Status Verified: 2014-12
• Study First Submitted: 2014-12-15
• Study First Submitted QC: 2014-12-17
• Last Update Submitted: 2014-12-17
• Study First Posted: 2014-12-18
• Last Update Posted: 2014-12-18
• Study Start: 2015-03
• Primary Completion: 2015-06
• Study Completion: 2015-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 70

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beetroot juice (BRJ)	Beetroot juice	beetroot juice
Placebo (PL)	Placebo beetroot juice	placebo juice

Primary Outcome Measures

Name	Time	Method
anaerobic threshold (AT)	1 year	The change in the anaerobic threshold (AT) after beetroot juice supplementation.
maximal oxygen uptake (VO2Max)	1 year	The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.