Soy Tomato Juice to Improve Outcomes in Pancreatitis

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Ohio State University
Study ID
NCT07447687
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Soy-tomato juice product — DIETARY_SUPPLEMENT
    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.
  • Will include a soy-tomato juice product to be consumed during the 4 week intervention phase. A total of about 12 ounces (administered in two small cans) of the juice will be consumed — DIETARY_SUPPLEMENT
    This is a novel dietary supplement.

Study Details

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.

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2027
Completion
Jun 30, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: soy-tomato juice
    4 week run-in phase where they are asked to consume a diet low in soy and lycopene, then they will receive the intervention for 4 weeks.

Primary Outcome Measure

Safety of the Dietary Intervention [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Ohio State University Wexner Medical CenterColumbusOhio43210
Spencer Harris
[email protected]
614-293-6255
Phil A Hart, MD (PRINCIPAL_INVESTIGATOR)
Mitchell L Ramsey, MD (SUB_INVESTIGATOR)

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By research site
The Ohio State University Wexner Medical Center· Columbus, OH

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