Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps
NCT ID: NCT06335420
Last Updated: 2025-11-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
400 participants
INTERVENTIONAL
2024-06-20
2027-12-01
Brief Summary
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The main question it aims to answer is: Will carrot juice rich in polyacetylenes inhibit neoplastic transformation and growth in high-risk humans?
Participants will have to drink 100 ml of juice daily after the adenoma resection for 1 year and keep a simple diary/calendar.
Researchers 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.
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Detailed Description
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The 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):
1. 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)
2. The assessment of patient compliance and ways to improve it (Umeå Institute of Design, Umeå University - UMU).
The 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.
Outcomes will be investigated through standard colonoscopy report, questionnaires, calendars and diaries.
The randomization is stratified by inclusion center, each having its own block of 50/50 distribution between active and placebo arm.
The 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.
All 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.
Data 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.
Participation is voluntary with no economic compensation, and the patients are informed orally and in writing according to the information accepted by the ethics committee.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Carrot juice
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.
Analysis 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.
Carrot juice from Yellowstone carrots cultivars
Consumption of 100 ml of carrot juice daily for 1 year
Placebo juice
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.
Placebo juice
Consumption of 100 ml of placebo juice daily for 1 year
Interventions
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Carrot juice from Yellowstone carrots cultivars
Consumption of 100 ml of carrot juice daily for 1 year
Placebo juice
Consumption of 100 ml of placebo juice daily for 1 year
Eligibility Criteria
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Inclusion Criteria
2. Acceptance of the treatment and follow-up program.
3. Capability to understand and follow the instructions.
Exclusion Criteria
2. Pregnancy.
3. Known relevant allergies.
4. Chronic consumption of COX (cyclooxygenase) inhibitors (Aspirin, Celecoxib, Ibuprofen, Diclofenac, Ketoprofen, Ketorolac, Indometacin, Naproxen, Piroxicam) or immunosuppressive agents (Methotrexate, Azathioprine or glucocorticoids).
5. Patients with different neoplastic disease under treatment (Chemo-/Radio-/Imunotherapy).
6. Severe comorbidity NYHA III-IV.
7. Lynch syndrome.
18 Years
ALL
No
Sponsors
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Karolinska Institutet
OTHER
Umeå University
OTHER
Uppsala University Hospital
OTHER
Svendborg Hospital
OTHER
Ersta Hospital, Sweden
OTHER
St Goran's Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Odense University Hospital
OTHER
Responsible Party
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Principal Investigators
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Gunnar Baatrup, Professor
Role: PRINCIPAL_INVESTIGATOR
OUH og Svendborg Sygehus
Locations
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Department of Surgery, Odense University Hospital
Odense, , Denmark
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Schmiech L. Strukturafklârung und qualitative Studien zu Bitterstoffen und Polyacetylenen in Karitten. Verlag Dr. Hut, 2011, ISBN 978-3-8439-0069-0
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Informed Consent Form
Other Identifiers
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324-2023-GB
Identifier Type: -
Identifier Source: org_study_id
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