Description Module

Description Module

The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.

Description Module path is as follows:

Study -> Protocol Section -> Description Module

Description Module


Ignite Creation Date: 2025-12-24 @ 11:19 PM
Ignite Modification Date: 2025-12-24 @ 11:19 PM
NCT ID: NCT02319356
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: NCT02319356
Study Brief:
Protocol Section: NCT02319356