Chronic Pancreatitis, Recurrent Acute Pancreatitis
Conditions
Keywords
Soy, Tomato, Dietary Intervention, abdominal pain, inflammation, lycopene, soy isoflavones, anti-inflammatory diet, medical nutrition, diet, Ohio State University
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.
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_SUPPLEMENTSoy-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_SUPPLEMENTWill 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.
Sponsors
Ohio State University
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Single arm, open label
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety of the Dietary Intervention | 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) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Determine the Change in Inflammatory Marker Levels | From enrollment to the end of treatment at 8 weeks | 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. |
Countries
United States
Contacts
CONTACTSpencer Harris
Outcome results
None listed