Soy Tomato Juice to Improve Outcomes in Pancreatitis

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

• Ages 18 to 80 years
• All sexes
• No healthy volunteers
• Adult, Older adult

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

About this study

Official title: Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial

Conditions

Recurrent Acute Pancreatitis, Chronic Pancreatitis

Being tested

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

Keywords

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

Medical subject headings

Pancreatitis, Pancreatitis, Chronic, Abdominal Pain, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

• Soy-tomato juice productDietary 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 consumedDietary supplement

  This is a novel dietary supplement.

What is being measured

The primary outcome is the main question the study is designed to answer.

1. Safety of the Dietary Intervention

   Safety will be evaluated by monitoring adverse events throughout the study. Information will be collected through routine study assessments, including participant interactions, diary entries, vital signs, and standard clinical laboratory testing. Adverse events will be graded using the Common Terminology Criteria for Adverse Events (CTCAE v.5.0). For this study, we define a dose-limiting toxicity (DLT) as the appearance of any adverse event reaching Grade 3-5 toxicity or that otherwise prevents continuation of the intervention.

   Adverse events will be graded using established clinical criteria, and the number and severity of events observed during the intervention period will be summarized to determine the rate of dose-limiting toxicities

   Measured: From enrollment to the end of treatment at 8 weeks

2. Assessment of Compliance With the Dietary Intervention (soy)

   Participant adherence to the dietary intervention will be monitored using daily self-report diaries, where individuals record how much of the study beverage they consumed each day. These entries will be used to assess overall adherence across the intervention period without disclosing any specific targets or thresholds to participants.

   In addition to self-reports, the study will also evaluate biological markers of dietary intake. Levels of compounds derived from the soy components of the beverage (isoflavone metabolites)) will be measured in urine collected before and after the intervention.

   Measured: From enrollment to the end of treatment at 8 weeks

3. Assessment of Compliance With the Dietary Intervention (lycopene)

   Description: In addition to self-reports and assessment of soy metabolites, investigators will also evaluate biological markers of dietary intake. Levels of compounds derived from the lycopene components of the beverage will be measured in plasma collected before and after the intervention.

   Measured: From enrollment to the end of treatment at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1. First posted3 Mar 2026
2. Study start2 Apr 2026
3. Primary completion14 Jan 2028 (estimated)
4. Study completion1 Jun 2028 (estimated)

Resources

• Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
• Other trials for Recurrent Acute PancreatitisStudies of the same condition, open and under way.
• More trials run by Ohio State UniversityThe sponsor's other registered studies.
• What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.