Does Dietary Nitrate Supplementation Improve Aerobic Performance
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Beetroot juice
Placebo beetroot juice
Sponsored by
About this trial
This is an interventional supportive care trial for Colorectal Cancer
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Beetroot juice (BRJ)
Placebo (PL)
Arm Description
beetroot juice
placebo juice
Outcomes
Primary Outcome Measures
anaerobic threshold (AT)
The change in the anaerobic threshold (AT) after beetroot juice supplementation.
maximal oxygen uptake (VO2Max)
The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.
Secondary Outcome Measures
Full Information
NCT ID
NCT02319356
First Posted
December 15, 2014
Last Updated
December 17, 2014
Sponsor
Royal Surrey County Hospital NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT02319356
Brief Title
Does Dietary Nitrate Supplementation Improve Aerobic Performance
Official Title
Does Dietary Nitrate Supplementation Improve Aerobic Performance in Colorectal Cancer? A Pilot Study
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Surrey County Hospital NHS Foundation Trust
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Beetroot juice (BRJ)
Arm Type
Active Comparator
Arm Description
beetroot juice
Arm Title
Placebo (PL)
Arm Type
Placebo Comparator
Arm Description
placebo juice
Intervention Type
Dietary Supplement
Intervention Name(s)
Beetroot juice
Other Intervention Name(s)
Beet it Sport Shots
Intervention Description
(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk)
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo beetroot juice
Other Intervention Name(s)
Nitrate deplete Beet it Sport Shots
Intervention Description
(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk)
Primary Outcome Measure Information:
Title
anaerobic threshold (AT)
Description
The change in the anaerobic threshold (AT) after beetroot juice supplementation.
Time Frame
1 year
Title
maximal oxygen uptake (VO2Max)
Description
The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Brown, MBBS, MRCS
Phone
00441483688691
Email
vanessabrown@doctors.org.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Mike Scott, MBChb FRCA
Phone
00441483464116
Email
mjpscott@btinternet.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Brown, MBBS, MRCS
Organizational Affiliation
Royal Surrey County Hospital Guildford
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
24791915
Citation
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.
Results Reference
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PubMed Identifier
20134313
Citation
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.
Results Reference
background
PubMed Identifier
22910977
Citation
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.
Results Reference
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Does Dietary Nitrate Supplementation Improve Aerobic Performance
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