Preventing Colorectal Polyps Growth Using Daily Carrot Juice
in Patients After Removal of Large Adenomas or Early Cancers
Led by Odense University Hospital · Updated on 2025-11-20
400
Participants Needed
1
Research Sites
26 weeks
Total Duration
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
Research Team
G
Gunnar Baatrup, Professor
A
Alexandra D Agache, Postdoc
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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
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
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
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
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...
Polyp prophylactic properties of polyacetylenes from carrots in patients with previous polypectomy-Px7 The study protocol of a multicentre binational randomised controlled trial.
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...