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

Colorectal Cancer Prevention Clinical Trial

— Px7  

Official title:

Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06335420
• Other study ID #: 324-2023-GB
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 2024
• Est. completion date: September 2026

Study information

• Verified date: March 2024
• Source: Odense University Hospital
• Contact: Gunnar Baatrup, Professor
• Phone: +4520575154
• Email: Gunnar.Baatrup[@]rsyd.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 FaOH/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.

Description:

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 three Swedish (Södersykehuset, Stockholm - KUH; University Hospital, Uppsala - UUH; Sahlgrenska Goteborg - SUH).

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 a combined endpoint of total number of recurrent adenomas multiplied with mean 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 diares.

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 3 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 400
• Est. completion date: September 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Any type of resection for adenomas larger than 20 mm in size (endoscopically evaluated).

2. Acceptance of the treatment and follow-up program.

3. Capability to understand and follow the instructions.

Exclusion Criteria:

1. Patients allocated to "high-risk" group because of many small polyps (>4).

2. Pregnancy.

3. Known relevant allergies.

4. Chronic consumption of COX inhibitors (Aspirin, Celecoxib, Ibuprofen, Diclofenac, Ketoprofen, Ketorolac, Indometacin, Naproxen, Piroxicam) or immunosuppresive agents (Methotrexate, Azathioprine or glucocorticoids)

Related Conditions & MeSH terms

• Colorectal Cancer Prevention
• Colorectal Neoplasms

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Denmark	Department of Surgery, Odense University Hospital	Odense

Sponsors (6)

Lead Sponsor	Collaborator
Odense University Hospital	Karolinska Institutet, Sahlgrenska University Hospital, Sweden, Svendborg Hospital, Umeå University, Uppsala University Hospital

Country where clinical trial is conducted

Denmark, 

References & Publications (9)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and size of polyps found at the one-year follow up colonoscopy	The combined endpoint (number x size of polyps) after 1 year of treatment.	1 year
Secondary	Polyp number and size in relation to carrot consumption measurement	A covariate analysis of carrot consumption (concentration of polyacetylenes expoure)measured through diaries, calendar and questionnaires and the findings at the 1 year colonoscopy	1 year
Secondary	Compliance rate (Juice consumption level)	Assesment of compliance rate through diary, calendar marks and questionnaire	1 year
Secondary	Side effects	Assesment of side effects through questionnaire	1 year
Secondary	Acceptability of treatment	Assesment of acceptance and ways to improve carrot products through diary and questionnaire	1 year