Does Dietary Nitrate Supplementation Improve Aerobic Performance in Colorectal Cancer? A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 70
- 主要终点
- anaerobic threshold (AT)
研究概览
简要总结
The purpose of this study is to determine whether dietary nitrate supplementation improves performance in cardiopulmonary exercise testing (CPET).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective Colonic or rectal resection.
排除标准
- •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
结局指标
主要结局
anaerobic threshold (AT)
时间窗: 1 year
The change in the anaerobic threshold (AT) after beetroot juice supplementation.
maximal oxygen uptake (VO2Max)
时间窗: 1 year
The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.
次要结局
未报告次要终点
研究者
Vanessa Brown
Responsible research fellow
Royal Surrey County Hospital NHS Foundation Trust