Colorectal CancerEarly Phase 1NCT02319356
Does Dietary Nitrate Supplementation Improve Aerobic Performance
A Early Phase 1 study testing Beetroot juice in people with Colorectal Cancer, run by Royal Surrey County Hospital NHS Foundation Trust.
Trial summary
The purpose of this study is to determine whether dietary nitrate supplementation improves performance in cardiopulmonary exercise testing (CPET). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Beetroot juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Mar 2015to Jun 2015
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Elective Colonic or rectal resection.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Does Dietary Nitrate Supplementation Improve Aerobic Performance in Colorectal Cancer? A Pilot Study
The purpose of this study is to determine whether dietary nitrate supplementation improves performance in cardiopulmonary exercise testing (CPET).
Read the 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.
- Conditions
- Colorectal Cancer
- Being tested
- Beetroot juice, Placebo beetroot juice
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beetroot juiceDietary supplement
Also called Beet it Sport Shots
(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk)
Placebo beetroot juiceDietary supplement
Also called Nitrate deplete Beet it Sport Shots
(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk)
| Study group | Role | What they receive |
|---|---|---|
| Beetroot juice (BRJ) | Active comparator | beetroot juice Receives: Dietary Supplement: Beetroot juice |
| Placebo (PL) | Placebo comparator | placebo juice Receives: Dietary Supplement: Placebo beetroot juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
anaerobic threshold (AT)
The change in the anaerobic threshold (AT) after beetroot juice supplementation.
Measured: 1 year
maximal oxygen uptake (VO2Max)
The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vanessa Brown, Royal Surrey County Hospital NHS Foundation Trust
- Investigators
- Vanessa Brown, MBBS, MRCS, Principal investigator, Royal Surrey County Hospital Guildford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02319356
- Sponsor's protocol ID
- 163841
- Status last verified
- Dec 2014
- First submitted
- 15 Dec 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
Publications
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.
PubMed 24791915Snowden 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.
PubMed 20134313Colson 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.
PubMed 22910977
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Dietary Nitrate Supplementation Improve Aerobic Performance in Colorectal Cancer? A Pilot Study
- ClinicalTrials.gov ID
- NCT02319356
- Acronym / sponsor ID
- 163841
- Conditions
- Colorectal Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Royal Surrey County Hospital NHS Foundation TrustUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 18 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beetroot juice (BRJ) | Active comparator | Dietary Supplement: Beetroot juicebeetroot juice |
| Placebo (PL) | Placebo comparator | Dietary Supplement: Placebo beetroot juiceplacebo juice |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Elective Colonic or rectal resection.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beetroot juiceAlso: Beet it Sport Shots(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk) | Dietary supplement | Beetroot juice (BRJ) |
| Placebo beetroot juiceAlso: Nitrate deplete Beet it Sport Shots(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk) | Dietary supplement | Placebo (PL) |
Primary outcome
anaerobic threshold (AT)
Time frame: 1 year
The change in the anaerobic threshold (AT) after beetroot juice supplementation.
maximal oxygen uptake (VO2Max)
Time frame: 1 year
The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
- Background: PubMed 24791915Jones 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.
- Background: PubMed 20134313Snowden 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.
- Background: PubMed 22910977Colson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vanessa Brown, MBBS, MRCS principal investigator
Royal Surrey County Hospital Guildford
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Beetroot juice in people with Colorectal Cancer, run by Royal Surrey County Hospital NHS Foundation Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vanessa Brown, MBBS, MRCS (00441483688691, vanessabrown@doctors.org.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
anaerobic threshold (AT) (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02319356, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.