Prophylactic Properties of Carrot Juice in Patients With High-Risk Colorectal Polyps

NCT06335420 | Recruiting DMC

• 1 other identifier: 324-2023-GB
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

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. 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.

Conditions

Colorectal Cancer Prevention

Outcome Measures

Primary Outcomes (1)

• Number and size of recurrent polyps found at the one-year follow up colonoscopy

  The combined endpoint (number x size of recurrent polyps) after 1 year of treatment.

  1 year

Secondary Outcomes (4)

• Polyp number and mean size per patient and the relation with the carrot consumption measurement

  1 year

• Compliance rate (Juice consumption level) and side effects

  1 year

• The number of polyps with low, medium, high degree of dysplasia and cancer

  1 year

• Acceptability of treatment

  1 year

Study Arms (2)

Carrot juice

ACTIVE COMPARATOR

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.

Dietary Supplement: Carrot juice from Yellowstone carrots cultivars

Placebo juice

PLACEBO COMPARATOR

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.

Dietary Supplement: Placebo juice

Interventions

Carrot juice from Yellowstone carrots cultivars DIETARY_SUPPLEMENT

Consumption of 100 ml of carrot juice daily for 1 year

Carrot juice

Placebo juice DIETARY_SUPPLEMENT

Consumption of 100 ml of placebo juice daily for 1 year

Placebo juice

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Any type of resection for adenomas larger than 20 mm in size (endoscopically evaluated) or endoscopically resected T1 cancers.
• Acceptance of the treatment and follow-up program.
• Capability to understand and follow the instructions.

You may not qualify if:

• Patients allocated to "high-risk" group because of many small polyps (\>4).
• Pregnancy.
• Known relevant allergies.
• Chronic consumption of COX (cyclooxygenase) inhibitors (Aspirin, Celecoxib, Ibuprofen, Diclofenac, Ketoprofen, Ketorolac, Indometacin, Naproxen, Piroxicam) or immunosuppressive agents (Methotrexate, Azathioprine or glucocorticoids).
• Patients with different neoplastic disease under treatment (Chemo-/Radio-/Imunotherapy).
• Severe comorbidity NYHA III-IV.
• Lynch syndrome.

Sponsors & Collaborators

• Odense University Hospital: lead
• Karolinska Institutet: collaborator
• Umeå University: collaborator
• Uppsala University Hospital: collaborator
• Svendborg Hospital: collaborator
• Ersta Hospital, Sweden: collaborator
• St Goran's Hospital: collaborator
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Department of Surgery, Odense University Hospital

Odense, 5000, Denmark

RECRUITING

Related Publications (10)

• 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.

  PMID: 36771385 BACKGROUND

• Schmiech L. Strukturafklârung und qualitative Studien zu Bitterstoffen und Polyacetylenen in Karitten. Verlag Dr. Hut, 2011, ISBN 978-3-8439-0069-0

  BACKGROUND

• 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: 36771338 BACKGROUND

• 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: 36088746 BACKGROUND

• 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: 32012660 BACKGROUND

• 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: 31540047 BACKGROUND

• 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: 29945666 BACKGROUND

• 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: 28197615 BACKGROUND

• 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: 15740080 BACKGROUND

• 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.

  PMID: 41314836 DERIVED

Study Officials

• Gunnar Baatrup, Professor

  OUH og Svendborg Sygehus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gunnar Baatrup, Professor

CONTACT

+4520575154; Gunnar.Baatrup@rsyd.dk

Alexandra D Agache, Postdoc

CONTACT

+4520355717; Alexandra.Agache@rsyd.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 28, 2024
• Study Start: June 20, 2024
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: November 20, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)