Soy-Tomato Juice for Pancreatitis
This study is testing a special soy-tomato juice product for people with recurrent acute pancreatitis (RAP) or chronic pancreatitis (CP). The goal is to see if you can tolerate and regularly drink this juice, which has high levels of lycopene (a powerful antioxidant found in tomatoes). Researchers will also look at how the juice affects inflammation and your overall well-being. Everyone in the study will receive the soy-tomato juice, and both you and the researchers will know you are taking it. The study aims to enroll 35 participants aged 18 to 80 who have a definite diagnosis of CP or RAP and can fully participate. You cannot join if you've had an acute pancreatitis episode, hospitalization, or surgery within 30 days of enrollment, or if you take certain daily immunomodulatory medications. This study is currently recruiting.
- Study design
- This is a pilot, single-arm, open-label study involving 35 participants. This means everyone receives the soy-tomato juice, and both you and the researchers know what is being taken.
- What's involved
- You will first have a 4-week period where you eat a modified diet low in soy and lycopene. Then, you will drink about 12 ounces of the soy-tomato juice daily for 4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study will assess safety and compliance with the dietary intervention from enrollment to the end of treatment at 8 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Soy Tomato Juice to Improve Outcomes in Pancreatitis
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- Safety of the Dietary InterventionFrom 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)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)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.