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Colorectal Cancer PreventionPx7NCT06335420

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

A study testing Carrot juice from Yellowstone carrots cultivars in people with Colorectal Cancer Prevention, run by Odense University Hospital at 1 site in Denmark.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer Prevention
What is being tested?
Carrot juice from Yellowstone carrots cultivars
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
400 participants
Where
1 siteDenmark
Study dates
20 Jun 2024to 1 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gunnar Baatrup, Professor contact

+4520575154

Gunnar.Baatrup@rsyd.dk

Alexandra D Agache, Postdoc contact

+4520355717

Alexandra.Agache@rsyd.dk

Denmark1 site, 1 recruiting
  • Department of Surgery, Odense University Hospital

    Odense, 5000

    Alexandra Agache, postdoc researcher, +4520355717, Alexandra.Agache@rsyd.dk

    Michael B Mortensen, MD, Ph.D.

    Recruiting

Other trials in Denmark

About this study

Official title: Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy

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?

Read more

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.

Read the detailed 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 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):

  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.

Being tested
Carrot juice from Yellowstone carrots cultivars, Placebo juice

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Carrot juice from Yellowstone carrots cultivarsDietary supplement

    Consumption of 100 ml of carrot juice daily for 1 year

  • Placebo juiceDietary supplement

    Consumption of 100 ml of placebo juice daily for 1 year

Study groups in NCT06335420
Study groupRoleWhat they receive
Carrot juiceActive comparatorThe 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.
Receives: Dietary Supplement: Carrot juice from Yellowstone carrots cultivars
Placebo juicePlacebo comparatorPlacebo 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.
Receives: Dietary Supplement: Placebo juice

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 1 year

Secondary outcomes (4)
  1. 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).

    Measured: 1 year

  2. Compliance rate (Juice consumption level) and side effects

    Assessment of compliance rate and side effects through diary, calendar marks and questionnaire

    Measured: 1 year

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

    Assessment of polyps through endoscopy and pathology reports

    Measured: 1 year

  4. Acceptability of treatment

    Assessment of acceptance and ways to improve carrot products through diary and questionnaire

    Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2024
  2. Study start20 Jun 2024
  3. Primary completion1 Jun 2027 (estimated)
  4. Study completion1 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06335420
Sponsor's protocol ID
324-2023-GB
Acronym
Px7
Status last verified
Sep 2025
First submitted
13 Mar 2024
Last updated
20 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 36771385
  • 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.

    PubMed 36771338
  • 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.

    PubMed 36088746
  • 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.

    PubMed 32012660
  • 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.

    PubMed 31540047
  • 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.

    PubMed 29945666
  • 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.

    PubMed 28197615
  • 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.

    PubMed 15740080
  • 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.

    PubMed 41314836

Questions about this trial

What is this clinical trial studying?

A study testing Carrot juice from Yellowstone carrots cultivars in people with Colorectal Cancer Prevention, run by Odense University Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gunnar Baatrup, Professor (+4520575154, Gunnar.Baatrup@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number and size of recurrent polyps found at the one-year follow up colonoscopy (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06335420, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2025.

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