Soy Tomato Juice to Improve Outcomes in Pancreatitis (STOP)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Pancreatitis; Recurrent Acute Pancreatitis
• Intervention / Treatment: Dietary supplement: Soy-tomato juice product; Dietary supplement: 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

Detailed Description

This is a pilot, single arm, open label clinical trial to assess the tolerability and compliance of a soy-tomato juice dietary intervention in participants with recurrent acute pancreatitis (RAP) / chronic pancreatitis (CP) and evaluate the effects of the diet on inflammation and patient-reported outcomes (PROs). The investigators hypothesize this diet will be well tolerated, reduce measures of systemic inflammation, and potentially improve PROs.

During the trial, participants will complete a 4-week run-in phase where they are asked to consume a modified diet low in soy and lycopene. Then, participants will be provided 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 daily.

• Study Type: Interventional
• Enrollment (Estimated): 35
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Spencer Harris; Phone Number: 614-293-6255; Email: spencer.harris@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Wexner Medical Center
      • Contact: Spencer Harris; Phone Number: 614-293-6255; Email: spencer.harris@osumc.edu
      • Principal Investigator: Phil A Hart, MD
      • Sub-Investigator: Mitchell L Ramsey, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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.

Dietary supplement: 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.; Dietary supplement: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	From enrollment to the end of treatment at 8 weeks
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.	From enrollment to the end of treatment at 8 weeks
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.	From enrollment to the end of treatment at 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the Change in Inflammatory Marker Levels	Changes in circulating inflammatory markers will be evaluated before and after the dietary intervention. Concentrations (pg/mL) of key markers (Interleukin-5, Interleukin-1beta, Tumor Necrosis Factor-alpha) will be measured using standard laboratory techniques to characterize overall shifts in inflammation-related signaling. The analysis will help determine whether the intervention is associated with measurable changes in the body's inflammatory profile over time.	From enrollment to the end of treatment at 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the Change in Physical Activity Levels	Physical activity will be evaluated at two points during the study using a validated wearable activity monitor. The amount of daily activity, expressed in minutes, will be analyzed as a continuous measure. This assessment provides an estimate of both sedentary behavior and ambulatory movement in real-world settings, allowing us to characterize overall patterns of physical activity during the trial.	From enrollment to the end of treatment at 8 weeks
Determine the Change in Average Abdominal Pain Score	Changes in abdominal pain will be evaluated throughout the study. Pain intensity will be measured at each study visit and through daily participant diaries using the standard numeric rating scale (range of 0-10; higher value represents higher pain intensity). This approach provides a simple, widely used quantitative measure of abdominal discomfort, allowing us to track overall patterns of pain over the course of the trial	From enrollment to the end of treatment at 8 weeks
Determine the Change in Quality of Life	Quality of life will be assessed at multiple time points using a validated questionnaire specific to pancreatitis (Pancreatitis Quality of Life, PANQOLI). Overall scores on this scale range from 0 to 103, with higher scores indicating a better quality of life. Changes from baseline in the overall composite score will be evaluated to understand how participants' quality-of-life experiences shift over the course of the study.	From enrollment to the end of treatment at 8 weeks

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study record dates

Study Major Dates

• Study Start (Estimated): February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 3, 2026

Study Record Updates

• Last Update Posted (Actual): March 3, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Soy; inflammation; diet; Dietary Intervention; abdominal pain; Tomato; lycopene; soy isoflavones; anti-inflammatory diet; medical nutrition; Ohio State University
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathologic Processes; Chronic Disease; Disease Attributes; Signs and Symptoms, Digestive; Digestive System Diseases; Pancreatic Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Abdominal Pain; Pancreatitis; Pancreatitis, Chronic; Inflammation
• Other Study ID Numbers: STUDY20252188; R01DK138871 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No