Soy Tomato Juice to Improve Outcomes in Pancreatitis
Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial
Ohio State University
35 participants
Feb 1, 2026
INTERVENTIONAL
Conditions
Summary
This goal of this clinical trial is to see if people with recurrent acute pancreatitis or chronic pancreatitis can tolerate and regularly drink a tomato juice beverage. Researchers will also measure inflammation and ask participants to report how they feel. Everyone in the study will receive the tomato juice drink, and both participants and researchers will know what is being taken. The investigators expect the drink will be well tolerated, may lower inflammation, and may improve participant-reported symptoms and quality of life.
Eligibility
Inclusion Criteria2
- Diagnosis of definite chronic pancreatitis (CP) or recurrent acute pancreatitis (RAP)
- Patients should be able to fully understand and participate in all aspects of the study
Exclusion Criteria4
- Episode of acute pancreatitis, hospitalization, or endoscopic/surgical intervention within 30 days of enrollment
- Chronic, daily use of systemic immunomodulatory medication for any indication
- Previous allergic reaction to soy or tomato products
- Known pregnancy
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Interventions
A high lycopene tomato (with levels 2-3x higher than typical) will be grown at OSU farms, as we have done previously. Tomatoes will be harvested and transported to OSU's Food Industries Center (Columbus, OH) for processing into juice and canned using commercial methods. A soy isoflavone extract will be acquired from a commercial supplier, tested for isoflavone content, and dosed into the juice before canning. Our juice recipe has been formulated and previously tested to ensure palatability. Proximate analysis (i.e., the information found on a nutrition facts panel) will be collected from our final juice, along with carotenoid and soy isoflavone levels to fully characterize our intervention agent.
This is a novel dietary supplement.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07447687