Soy Tomato Juice to Improve Outcomes in Pancreatitis
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorOhio State University
About this 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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Soy-tomato juice product
Dietary supplementA 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.
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 supplementThis is a novel dietary supplement.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: soy-tomato juiceExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
From enrollment to the end of treatment at 8 weeks2
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.
Time frame
From enrollment to the end of treatment at 8 weeks3
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.
Time frame
From enrollment to the end of treatment at 8 weeksSecondary outcomes
1
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.
Time frame
From enrollment to the end of treatment at 8 weeksOther outcomes
1
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.
Time frame
From enrollment to the end of treatment at 8 weeks2
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
Time frame
From enrollment to the end of treatment at 8 weeks3
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.
Time frame
From enrollment to the end of treatment at 8 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Ohio State University
Lead sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
Source ClinicalTrials.gov