Soy Tomato Juice to Improve Outcomes in Pancreatitis

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

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.

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.

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.

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.

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

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.