Soy Tomato Juice to Improve Outcomes in Pancreatitis

NCT07447687 | Recruiting Phase 1

• 2 other identifiers: STUDY20252188R01DK138871
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Determine the Change in Inflammatory Marker Levels

  From enrollment to the end of treatment at 8 weeks

Other Outcomes (3)

• Determine the Change in Physical Activity Levels

  From enrollment to the end of treatment at 8 weeks

• Determine the Change in Average Abdominal Pain Score

  From enrollment to the end of treatment at 8 weeks

• Determine the Change in Quality of Life

  From enrollment to the end of treatment at 8 weeks

Study Arms (1)

soy-tomato juice

EXPERIMENTAL

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; 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

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.

soy-tomato juice

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.

soy-tomato juice

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic; Abdominal Pain; Inflammation

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Signs and Symptoms, Digestive

Central Study Contacts

Spencer Harris

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Model Details: Single arm, open label

Study Record Dates

• First Submitted: February 2, 2026
• First Posted: March 3, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)