Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06335420

Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy

Led by Odense University Hospital · Updated on 2025-11-20

400

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

O

Odense University Hospital

Lead Sponsor

K

Karolinska Institutet

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating whether drinking carrot juice rich in polyacetylenes can help prevent the return and growth of high-risk colorectal polyps in patients who have undergone adenoma resection. This prospective, randomized, double-blinded trial takes place across multiple centers in Denmark and Sweden, aiming to see if the active compounds falcarinol and falcarindiol reduce neoplastic transformation in these patients. Participants are randomly assigned to one of two groups: one drinks 100 ml of active carrot juice daily, and the other drinks 100 ml of placebo juice daily, both for one year. The juices are carefully produced and taste-matched to keep the study blinded. Patients receive juice supplies and keep a diary or calendar to track consumption. A follow-up colonoscopy is scheduled after one year, with an additional six-month colonoscopy for those with piecemeal resections. During the study, patients attend visits every two months to collect juice and questionnaires and discuss adherence with a nurse. Researchers monitor compliance by measuring juice consumption and analyze outcomes such as the number and size of recurrent polyps, polyp dysplasia levels, side effects, and treatment acceptability. The primary outcome is the number and size of recurrent polyps found at the one-year colonoscopy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Any type of resection for adenomas larger than 20 mm or endoscopically resected T1 cancers
  • Acceptance of the treatment and follow-up program
  • Ability to understand and follow study instructions
Not Eligible

You will not qualify if you...

  • High-risk patients with more than 4 small polyps
  • Pregnancy
  • Known relevant allergies
  • Chronic use of COX inhibitors or immunosuppressive agents
  • Patients currently receiving treatment for other neoplastic diseases
  • Severe comorbidity classified as NYHA III-IV
  • Lynch syndrome

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Treatment

Duration - 1 year

Participants consume 100 ml of carrot juice or placebo juice daily for 1 year.

Visits every 2 months for juice collection, diary, calendar, questionnaire, and follow-up discussion with the project nurse

Follow-up

Duration - Up to 1 year with a 6-month colonoscopy for some participants

Participants undergo colonoscopy to assess the number and size of recurrent polyps after 1 year. Additional local follow-up colonoscopy occurs at 6 months for piecemeal resections.

1 colonoscopy visit at 1 year and 1 additional colonoscopy visit at 6 months if applicable

Trial Site Locations

Total: 1 location

1

Department of Surgery, Odense University Hospital

Odense, Denmark, 5000

Actively Recruiting

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Research Team

G

Gunnar Baatrup, Professor

A

Alexandra D Agache, Postdoc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

Effect of Oral Intake of Carrot Juice on Cyclooxygenases and Cytokines in Healthy Human Blood Stimulated by Lipopolysaccharide.

Ulrik Deding, Bettina Hjelm Clausen, Issam Al-Najami...

https://pubmed.ncbi.nlm.nih.gov/36771338

Quantification of the anti-neoplastic polyacetylene falcarinol from carrots in human serum by LC-MS/MS.

Ulla Jakobsen, Morten Kobæk-Larsen, Karoline D Kjøller...

https://pubmed.ncbi.nlm.nih.gov/36088746

Dietary Polyacetylenic Oxylipins Falcarinol and Falcarindiol Prevent Inflammation and Colorectal Neoplastic Transformation: A Mechanistic and Dose-Response Study in A Rat Model.

Morten Kobaek-Larsen, Gunnar Baatrup, Martine KhataeiNotabi...

https://pubmed.ncbi.nlm.nih.gov/31540047

Effect of the dietary polyacetylenes falcarinol and falcarindiol on the gut microbiota composition in a rat model of colorectal cancer.

Morten Kobaek-Larsen, Dennis Sandris Nielsen, Witold Kot...

https://pubmed.ncbi.nlm.nih.gov/29945666

Dietary polyacetylenes, falcarinol and falcarindiol, isolated from carrots prevents the formation of neoplastic lesions in the colon of azoxymethane-induced rats.

Morten Kobaek-Larsen, Rime B El-Houri, Lars P Christensen...

https://pubmed.ncbi.nlm.nih.gov/28197615

Inhibitory effects of feeding with carrots or (-)-falcarinol on development of azoxymethane-induced preneoplastic lesions in the rat colon.

Morten Kobaek-Larsen, Lars P Christensen, Werner Vach...

https://pubmed.ncbi.nlm.nih.gov/15740080

Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy-Px7 The study protocol of a multicentre binational randomised controlled trial.

Alexandra Agache, Ulrik Deding, Lasse Kaalby...

https://pubmed.ncbi.nlm.nih.gov/41314836