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Does Dietary Nitrate Supplementation Improve Aerobic Performance

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

Status
UNKNOWN
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02319356
Enrollment
70
Registered
2014-12-18
Start date
2015-03-31
Completion date
2015-06-30
Last updated
2014-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer

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.

Interventions

DIETARY_SUPPLEMENTBeetroot juice

(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk)

DIETARY_SUPPLEMENTPlacebo beetroot juice

(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk)

Sponsors

Royal Surrey County Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
anaerobic threshold (AT)1 yearThe change in the anaerobic threshold (AT) after beetroot juice supplementation.
maximal oxygen uptake (VO2Max)1 yearThe change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.

Contacts

Primary ContactVanessa Brown, MBBS, MRCS
vanessabrown@doctors.org.uk00441483688691
Backup ContactMike Scott, MBChb FRCA
mjpscott@btinternet.com00441483464116

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026