Polyp Prophylactic Properties of Polyacetylenes in Patients With Previous Polypectomy

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

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

• Acceptance of the treatment and follow-up program.

• Capability to understand and follow the instructions.

Locations
Other Locations
Denmark
Department of Surgery, Odense University Hospital
RECRUITING
Odense
Contact Information
Primary
Gunnar Baatrup, Professor
Gunnar.Baatrup@rsyd.dk
+4520575154
Backup
Alexandra D Agache, Postdoc
Alexandra.Agache@rsyd.dk
+4520355717
Time Frame
Start Date: 2024-06-20
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 400
Treatments
Active_comparator: Carrot juice
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_comparator: Placebo juice
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.
Related Therapeutic Areas
Sponsors
Leads: Odense University Hospital
Collaborators: St Goran's Hospital, Karolinska Institutet, Umeå University, Svendborg Hospital, Uppsala University Hospital, Sahlgrenska University Hospital, Ersta Hospital, Sweden

This content was sourced from clinicaltrials.gov

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