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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Umeå University | OTHER |
| Uppsala University Hospital | OTHER |
| Svendborg Hospital |
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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.
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).
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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carrot juice from Yellowstone carrots cultivars | Dietary Supplement | Consumption of 100 ml of carrot juice daily for 1 year |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp number and mean size per patient and the relation with the carrot consumption measurement | 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). | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gunnar Baatrup, Professor | Contact | +4520575154 | Gunnar.Baatrup@rsyd.dk | |
| Alexandra D Agache, Postdoc | Contact | +4520355717 | Alexandra.Agache@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Gunnar Baatrup, Professor | OUH og Svendborg Sygehus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Surgery, Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36771385 | Background | 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. | |
| Background | Schmiech L. Strukturafklârung und qualitative Studien zu Bitterstoffen und Polyacetylenen in Karitten. Verlag Dr. Hut, 2011, ISBN 978-3-8439-0069-0 | ||
| 36771338 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 12, 2024 | Jul 9, 2024 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 7, 2023 | Jul 9, 2024 | ICF_001.pdf |
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| OTHER |
| Ersta Hospital, Sweden | OTHER |
| St Goran's Hospital | OTHER |
| Sahlgrenska University Hospital | OTHER |
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| Placebo juice | Dietary Supplement | Consumption of 100 ml of placebo juice daily for 1 year |
|
| Compliance rate (Juice consumption level) and side effects | Assessment of compliance rate and side effects through diary, calendar marks and questionnaire | 1 year |
| The number of polyps with low, medium, high degree of dysplasia and cancer | Assessment of polyps through endoscopy and pathology reports | 1 year |
| Acceptability of treatment | Assessment of acceptance and ways to improve carrot products through diary and questionnaire | 1 year |
| 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. |
| 36088746 | 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. |
| 32012660 | 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. |
| 31540047 | 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. |
| 29945666 | 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. |
| 28197615 | 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. |
| 15740080 | 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. |
| 41314836 | Derived | 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. |