Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT06335420
Status:
RECRUITING
Last Update Posted:
2025-11-20
First Post:
2024-03-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-03-12', 'size': 953278, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2024-07-09T08:53', 'hasProtocol': True}, {'date': '2023-09-07', 'size': 424942, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-07-09T08:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2027-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-17', 'studyFirstSubmitDate': '2024-03-13', 'studyFirstSubmitQcDate': '2024-03-21', 'lastUpdatePostDateStruct': {'date': '2025-11-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number and size of recurrent polyps found at the one-year follow up colonoscopy', 'timeFrame': '1 year', 'description': 'The combined endpoint (number x size of recurrent polyps) after 1 year of treatment.'}], 'secondaryOutcomes': [{'measure': 'Polyp number and mean size per patient and the relation with the carrot consumption measurement', 'timeFrame': '1 year', 'description': 'A covariate analysis of carrot consumption (concentration of polyacetylenes exposure) measured through diaries, calendar and questionnaires and the findings at the 1 year colonoscopy (number of polyps multiplied by mean diameter of adenomas per patient).'}, {'measure': 'Compliance rate (Juice consumption level) and side effects', 'timeFrame': '1 year', 'description': 'Assessment of compliance rate and side effects through diary, calendar marks and questionnaire'}, {'measure': 'The number of polyps with low, medium, high degree of dysplasia and cancer', 'timeFrame': '1 year', 'description': 'Assessment of polyps through endoscopy and pathology reports'}, {'measure': 'Acceptability of treatment', 'timeFrame': '1 year', 'description': 'Assessment of acceptance and ways to improve carrot products through diary and questionnaire'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Colorectal Cancer Prevention']}, 'referencesModule': {'references': [{'pmid': '36771385', 'type': 'BACKGROUND', 'citation': 'Deding U, Baatrup G, Kaalby L, Kobaek-Larsen M. Carrot Intake and Risk of Developing Cancer: A Prospective Cohort Study. Nutrients. 2023 Jan 29;15(3):678. doi: 10.3390/nu15030678.'}, {'type': 'BACKGROUND', 'citation': 'Schmiech L. Strukturafklârung und qualitative Studien zu Bitterstoffen und Polyacetylenen in Karitten. Verlag Dr. Hut, 2011, ISBN 978-3-8439-0069-0'}, {'pmid': '36771338', 'type': 'BACKGROUND', 'citation': 'Deding U, Clausen BH, Al-Najami I, Baatrup G, Jensen BL, Kobaek-Larsen M. Effect of Oral Intake of Carrot Juice on Cyclooxygenases and Cytokines in Healthy Human Blood Stimulated by Lipopolysaccharide. Nutrients. 2023 Jan 26;15(3):632. doi: 10.3390/nu15030632.'}, {'pmid': '36088746', 'type': 'BACKGROUND', 'citation': 'Jakobsen U, Kobaek-Larsen M, Kjoller KD, Antonsen S, Baatrup G, Trelle MB. Quantification of the anti-neoplastic polyacetylene falcarinol from carrots in human serum by LC-MS/MS. J Chromatogr B Analyt Technol Biomed Life Sci. 2022 Nov 1;1210:123440. doi: 10.1016/j.jchromb.2022.123440. Epub 2022 Sep 6.'}, {'pmid': '32012660', 'type': 'BACKGROUND', 'citation': 'Deding U, Baatrup G, Christensen LP, Kobaek-Larsen M. Carrot Intake and Risk of Colorectal Cancer: A Prospective Cohort Study of 57,053 Danes. Nutrients. 2020 Jan 27;12(2):332. doi: 10.3390/nu12020332.'}, {'pmid': '31540047', 'type': 'BACKGROUND', 'citation': 'Kobaek-Larsen M, Baatrup G, KhataeiNotabi M, El-Houri RB, Pipo-Olle E, Christensen Arnspang E, Christensen LP. Dietary Polyacetylenic Oxylipins Falcarinol and Falcarindiol Prevent Inflammation and Colorectal Neoplastic Transformation: A Mechanistic and Dose-Response Study in A Rat Model. Nutrients. 2019 Sep 14;11(9):2223. doi: 10.3390/nu11092223.'}, {'pmid': '29945666', 'type': 'BACKGROUND', 'citation': 'Kobaek-Larsen M, Nielsen DS, Kot W, Krych L, Christensen LP, Baatrup G. Effect of the dietary polyacetylenes falcarinol and falcarindiol on the gut microbiota composition in a rat model of colorectal cancer. BMC Res Notes. 2018 Jun 27;11(1):411. doi: 10.1186/s13104-018-3527-y.'}, {'pmid': '28197615', 'type': 'BACKGROUND', 'citation': 'Kobaek-Larsen M, El-Houri RB, Christensen LP, Al-Najami I, Frette X, Baatrup G. Dietary polyacetylenes, falcarinol and falcarindiol, isolated from carrots prevents the formation of neoplastic lesions in the colon of azoxymethane-induced rats. Food Funct. 2017 Mar 22;8(3):964-974. doi: 10.1039/c7fo00110j.'}, {'pmid': '15740080', 'type': 'BACKGROUND', 'citation': 'Kobaek-Larsen M, Christensen LP, Vach W, Ritskes-Hoitinga J, Brandt K. Inhibitory effects of feeding with carrots or (-)-falcarinol on development of azoxymethane-induced preneoplastic lesions in the rat colon. J Agric Food Chem. 2005 Mar 9;53(5):1823-7. doi: 10.1021/jf048519s.'}, {'pmid': '41314836', 'type': 'DERIVED', 'citation': 'Agache A, Deding U, Kaalby L, Kobaek-Larsen M, Al-Najami I, Ostergaard Hansen L, Stryhn C, Wilde D, Forsberg A, Backman AS, Bates T, de Lange T, Martling A, Baatrup G. Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy-Px7 The study protocol of a multicentre binational randomised controlled trial. BMJ Open. 2025 Nov 28;15(11):e095376. doi: 10.1136/bmjopen-2024-095376.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this prospective randomized double-blinded bi-national study is to test the prophylactic effect of polyacetylenes from carrots on the population of patients who had a resection of high-risk adenomas of the large bowel.\n\nThe main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?\n\nParticipants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.\n\nResearchers will compare the group with ingestion of Falcarinol (FaOH) / Falcarindiol (FaDOH) rich carrot juice versus the group consuming placebo juice, to see if the polyacetylenes significantly reduces neoplastic transformation and growth in high-risk patients.', 'detailedDescription': 'The study is a prospective double-blinded randomized controlled trial carried out in four centers: one Danish (Department of Surgery, Odense University Hospital - OUH) and five Swedish (Ersta Hospital - EH, Stockholm; Karolinska University Hospital - KUH, Stockholm; Uppsala University Hospital - UUH, Uppsala; Sahlgrenska University Hospital - SUH, Goteborg, Capio St. Gorans Hospital - CSH, Stockholm).\n\nThe investigators will organize two parallel arms of 400 patients: an intervention arm (consumption of 100 ml active carrot juice daily) and a control arm (consumption of 100 ml placebo juice daily) in a 1:1 randomized allocation ratio for 1 year. The project is structured in 2 working packages (WP):\n\n1. The clinical trial (including cultivation and quality control of carrots and juice production; quantification of FaOH and FaDOH in the carrot and the placebo juice and the randomized trial)\n2. The assessment of patient compliance and ways to improve it (Umeå Institute of Design, Umeå University - UMU).\n\nThe investigators hypothesize that the difference between the active arm (carrot juice) and the control arm (placebo juice) measured by number and growth rate (size) of recurrent adenomas will mediate a 20% reduction or larger in both size and number.\n\nOutcomes will be investigated through standard colonoscopy report, questionnaires, calendars and diaries.\n\nThe randomization is stratified by inclusion center, each having its own block of 50/50 distribution between active and placebo arm.\n\nThe patients will collect 8 L of juice, the diary, calendar and a questionnaire every 2 months. At this meeting the patients will also have a follow-up discussion with the project nurse.\n\nAll patients will undergo colonoscopy after one year from the resection and in addition, for the piecemeal resections there will also be a local follow up colonoscopy after 6 months. Information about recurrence, the number of polyps, polyp size and characterization will be registered in the database. Full compliance is defined as consumption of \\> 75% of the juice delivered. Consumption data for all patients will be kept for compliance analysis.\n\nData will be analyzed using exact methods for binomial data. The combined endpoint will be the total number of recurrent adenomas multiplied with mean size of recurrent adenomas in the relevant treatment group.\n\nParticipation is voluntary with no economic compensation, and the patients are informed orally and in writing according to the information accepted by the ethics committee.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Any type of resection for adenomas larger than 20 mm in size (endoscopically evaluated) or endoscopically resected T1 cancers.\n2. Acceptance of the treatment and follow-up program.\n3. Capability to understand and follow the instructions.\n\nExclusion Criteria:\n\n1. Patients allocated to "high-risk" group because of many small polyps (\\>4).\n2. Pregnancy.\n3. Known relevant allergies.\n4. Chronic consumption of COX (cyclooxygenase) inhibitors (Aspirin, Celecoxib, Ibuprofen, Diclofenac, Ketoprofen, Ketorolac, Indometacin, Naproxen, Piroxicam) or immunosuppressive agents (Methotrexate, Azathioprine or glucocorticoids).\n5. Patients with different neoplastic disease under treatment (Chemo-/Radio-/Imunotherapy).\n6. Severe comorbidity NYHA III-IV.\n7. Lynch syndrome.'}, 'identificationModule': {'nctId': 'NCT06335420', 'acronym': 'Px7', 'briefTitle': 'Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy', 'orgStudyIdInfo': {'id': '324-2023-GB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Carrot juice', 'description': 'The cultivation of "Yellowstone" carrots will be conducted by DanRoots A/S.DanRoots, Organic Vegetables, Bjerringbro, Denmark.Juice is produced and taste corrected by Orskov Food, Denmark in collaboration with Naturfrisk, Ørbæk.\n\nAnalysis of carrot juice for falcarinol and falcarindiol content will be done at random from 10 samples leaving the factory and 10 samples collected after 30 days storage at participant\'s homes for each batch.', 'interventionNames': ['Dietary Supplement: Carrot juice from Yellowstone carrots cultivars']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo juice', 'description': 'Placebo juice is produced from natural flavours and taste corrected by Orskov Food, Denmark in collaboration with Naturfrisk, Ørbæk. The taste is corrected to prevent enabling differentiation between carrot juice and placebo.', 'interventionNames': ['Dietary Supplement: Placebo juice']}], 'interventions': [{'name': 'Carrot juice from Yellowstone carrots cultivars', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Consumption of 100 ml of carrot juice daily for 1 year', 'armGroupLabels': ['Carrot juice']}, {'name': 'Placebo juice', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Consumption of 100 ml of placebo juice daily for 1 year', 'armGroupLabels': ['Placebo juice']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Alexandra Agache, postdoc researcher', 'role': 'CONTACT', 'email': 'Alexandra.Agache@rsyd.dk', 'phone': '+4520355717'}, {'name': 'Michael B Mortensen, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Gunnar Baatrup, MD, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Surgery, Odense University Hospital', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'centralContacts': [{'name': 'Gunnar Baatrup, Professor', 'role': 'CONTACT', 'email': 'Gunnar.Baatrup@rsyd.dk', 'phone': '+4520575154'}, {'name': 'Alexandra D Agache, Postdoc', 'role': 'CONTACT', 'email': 'Alexandra.Agache@rsyd.dk', 'phone': '+4520355717'}], 'overallOfficials': [{'name': 'Gunnar Baatrup, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'OUH og Svendborg Sygehus'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Karolinska Institutet', 'class': 'OTHER'}, {'name': 'Umeå University', 'class': 'OTHER'}, {'name': 'Uppsala University Hospital', 'class': 'OTHER'}, {'name': 'Svendborg Hospital', 'class': 'OTHER'}, {'name': 'Ersta Hospital, Sweden', 'class': 'OTHER'}, {'name': "St Goran's Hospital", 'class': 'OTHER'}, {'name': 'Sahlgrenska University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}