search
Back to results

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
Royal Surrey County Hospital NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    December 15, 2014
    Last Updated
    December 17, 2014
    Sponsor
    Royal Surrey County Hospital NHS Foundation Trust
    search

    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
    background
    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
    background

    Learn more about this trial

    Does Dietary Nitrate Supplementation Improve Aerobic Performance

    We'll reach out to this number within 24 hrs