Recruiting
Phase 1
Phase 2

Tomato Juice

Sponsor:

Ohio State University

Code:

NCT07447687

Conditions

Recurrent Acute Pancreatitis

Chronic Pancreatitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Soy-tomato juice product

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

Study Details

Brief 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.

Conditions

Recurrent Acute Pancreatitis

Chronic Pancreatitis

Study ID

NCT07447687

Start date

Feb, 2026

Status verified date

Feb, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

35 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

Soy-tomato juice product

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

This is a novel dietary supplement.

Primary outcome measure

  • Safety of the Dietary Intervention [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
  • Assessment of Compliance With the Dietary Intervention (soy) [ Time Frame: From enrollment to the end of treatment at 8 weeks ]
  • Assessment of Compliance With the Dietary Intervention (lycopene) [ Time Frame: From enrollment to the end of treatment at 8 weeks ]

Central Contacts and Locations

Central contacts

Spencer Harris

614-293-6255spencer.harris@osumc.edu

Locations

The Ohio State University Wexner Medical Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Spencer Harris

614-293-6255spencer.harris@osumc.edu

Principal Investigator:

Phil A Hart, MD

More Information

Sponsor

Ohio State University

Last update posted

Mar 3, 2026

Last verified

Feb, 2026

Keywords

  • Soy
  • Tomato
  • Dietary Intervention
  • abdominal pain
  • inflammation
  • lycopene
  • soy isoflavones
  • anti-inflammatory diet
  • medical nutrition
  • diet
  • Ohio State University

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ohio State University on 2026-03-03.