NCT07447687 · Ohio State University
Soy Tomato Juice to Improve Outcomes in Pancreatitis
(STOP)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Safety of the Dietary Intervention
Time frame: From enrollment to the end of treatment at 8 weeks
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
Assessment of Compliance With the Dietary Intervention (soy)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Assessment of Compliance With the Dietary Intervention (lycopene)
Time frame: From enrollment to the end of treatment at 8 weeks
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Columbus, Ohio
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 3, 2026 · Source of record for eligibility and locations