Soy Tomato Juice to Improve Outcomes in Pancreatitis

Официальное название

Soy Tomato Juice to Improve Outcomes in Pancreatitis (the STOP Trial): a Phase 1/2 Single Arm Trial

Обзор

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.

Подробное описание

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.

Вмешательства

• Пищевая добавка 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
• Пищевая добавка 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.

Первичные конечные точки

• Safety of the Dietary Intervention [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Assessment of Compliance With the Dietary Intervention (soy) [Срок оценки: From enrollment to the end of treatment at 8 weeks]
• Assessment of Compliance With the Dietary Intervention (lycopene) [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Вторичные конечные точки (1)

• Determine the Change in Inflammatory Marker Levels [Срок оценки: From enrollment to the end of treatment at 8 weeks]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• The Ohio State University Wexner Medical Center — Columbus

Идентификаторы

NCT: NCT07447687 · STUDY20252188 · R01DK138871

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗