NCT02577640

Dietary Soy Isoflavones In Chronic Pancreatitis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: Ohio State University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Dietary Soy Isoflavones in Chronic Pancreatitis: Investigating the Anti-inflammatory Effects of Food Innovation Science on Gastrointestinal Disease

Detailed description

Management of pancreatic disorders imparts a major burden on healthcare costs, estimated at over 3 billion dollars annually. Chronic pancreatitis is characterized by chronic inflammation and progressive scarring, leading to abdominal pain, irreversible damage to the pancreas and the loss of both exocrine and endocrine function. Additionally, chronic pancreatic inflammation is a risk factor for pancreas cancer. There are no current treatments to modify the natural history of this disorder. Thus, identifying novel therapeutic options for this disease represents a high priority, and could fill an unmet medical need to improve quality of life, reduce risk of malignant transformation, and limit exorbitant medical costs associated with patient care. The investigators have assembled a multi-disciplinary research team to pursue an alternative, non-pharmacologic approach to limiting inflammatory cascades in (Chronic Pancreatitis) CP patients. They will assess compliance, toxicity and measure the changes in pro-inflammatory cytokine expression from a soy based dietary bread product using a classic 3+3 dose escalation study design in subjects with chronic pancreatitis.

Conditions

• Chronic Pancreatitis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Soy bread	Soy breads will be produced using a sponge-dough process. Finished dough will be formed, panned, and proofed in proofing cabinet (\~95% RH) at 40ºC for 60 minutes. Proofed loaves will be baked for 50 minutes at 150ºC in a convection oven (jet air oven, model: JA14, Doyon, Liniere, Quebec, Canada). Breads will be considered done at an internal temperature of 95 ± 5ºC.

Timeline

• Start date: 2015-07-01
• Primary completion: 2017-07-01
• Completion: 2017-07-01
• First posted: 2015-10-16
• Last updated: 2021-11-12
• Results posted: 2021-11-12

Locations

1 site across 1 country: United States