Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-03-06 @ 12:25 PM
Study NCT ID:
NCT02319356
Status:
UNKNOWN
Last Update Posted:
2014-12-18
First Post:
2014-12-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Does Dietary Nitrate Supplementation Improve Aerobic Performance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-12-17', 'studyFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2014-12-17', 'lastUpdatePostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-12-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anaerobic threshold (AT)', 'timeFrame': '1 year', 'description': 'The change in the anaerobic threshold (AT) after beetroot juice supplementation.'}, {'measure': 'maximal oxygen uptake (VO2Max)', 'timeFrame': '1 year', 'description': 'The change in the maximal oxygen uptake (VO2Max) after beetroot juice supplementation.'}]}, 'conditionsModule': {'conditions': ['Colorectal Cancer']}, 'referencesModule': {'references': [{'pmid': '24791915', 'type': 'BACKGROUND', '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.'}, {'pmid': '20134313', 'type': 'BACKGROUND', '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.'}, {'pmid': '22910977', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether dietary nitrate supplementation improves performance in cardiopulmonary exercise testing (CPET).', 'detailedDescription': "Dietary nitrate supplementation has been shown to enhance exercise tolerance and performance in professional athletes and physically active males.\n\nCardiopulmonary 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.\n\nThe 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.\n\nWe aim to study the effect of dietary nitrate supplementation on CPET results in patients awaiting surgery for colorectal cancer.\n\nOur primary outcome will be the change in the AT and VO2Max after beetroot juice supplementation.\n\nMethods: 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.\n\nThis 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective Colonic or rectal resection.\n\nExclusion Criteria:\n\n* Contraindication to cardiopulmonary exercise testing: unstable cardiac disease, lower limb dysfunction, inability to perform CPET\n* Inability to give informed consent\n* Emergency surgery\n* During CPET: Ischemic ECG or inability to reach AT\n* Allergy to Beetroot'}, 'identificationModule': {'nctId': 'NCT02319356', 'briefTitle': 'Does Dietary Nitrate Supplementation Improve Aerobic Performance', 'organization': {'class': 'OTHER', 'fullName': 'Royal Surrey County Hospital NHS Foundation Trust'}, 'officialTitle': 'Does Dietary Nitrate Supplementation Improve Aerobic Performance in Colorectal Cancer? A Pilot Study', 'orgStudyIdInfo': {'id': '163841'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Beetroot juice (BRJ)', 'description': 'beetroot juice', 'interventionNames': ['Dietary Supplement: Beetroot juice']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo (PL)', 'description': 'placebo juice', 'interventionNames': ['Dietary Supplement: Placebo beetroot juice']}], 'interventions': [{'name': 'Beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beet it Sport Shots'], 'description': '(BRJ, containing NO3-, 6.2 mmol/day, administered as 500ml Beet it Sport Shots, James White drinks, Ipswich uk)', 'armGroupLabels': ['Beetroot juice (BRJ)']}, {'name': 'Placebo beetroot juice', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Nitrate deplete Beet it Sport Shots'], 'description': '(PL, NO3-depleted beetroot juice, administered as 500ml Placebo Beet it Sport Shots, James White drinks, Ipswich uk)', 'armGroupLabels': ['Placebo (PL)']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Vanessa Brown, MBBS, MRCS', 'role': 'CONTACT', 'email': 'vanessabrown@doctors.org.uk', 'phone': '00441483688691'}, {'name': 'Mike Scott, MBChb FRCA', 'role': 'CONTACT', 'email': 'mjpscott@btinternet.com', 'phone': '00441483464116'}], 'overallOfficials': [{'name': 'Vanessa Brown, MBBS, MRCS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Royal Surrey County Hospital Guildford'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Royal Surrey County Hospital NHS Foundation Trust', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Responsible research fellow', 'investigatorFullName': 'Vanessa Brown', 'investigatorAffiliation': 'Royal Surrey County Hospital NHS Foundation Trust'}}}}