Soy Tomato Juice to Improve Outcomes in Pancreatitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: 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.
- Who it may be relevant to
- Registry conditions: Recurrent Acute Pancreatitis, Chronic Pancreatitis. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial
Overview
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.
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.
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. Prox - 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]
- 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]
Secondary outcome measures (1)
- Determine the Change in Inflammatory Marker Levels [Time frame: From enrollment to the end of treatment at 8 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- The Ohio State University Wexner Medical Center — Columbus
Identifiers
NCT: NCT07447687 · STUDY20252188 · R01DK138871