Dietary Soy Isoflavones In Chronic Pancreatitis

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

Study Overview

• Status: Completed
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Dietary supplement: Soy bread

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Philip Hart

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of chronic pancreatitis by fulfilling one of the following clinical scenarios:

   1. Presence of pancreatic calcifications
   2. Suggestive for chronic pancreatitis - consistent EUS criteria or at least 3 abnormal side branches on pancreatic duct imaging
   3. Indeterminate EUS findings for chronic pancreatitis with evidence of exocrine pancreatic insufficiency (EPI)
2. Age ≥18 years

Exclusion Criteria:

1. Inability to provide written consent
2. Inability to comply with the study protocol
3. Soy allergy
4. Pancreatic cancer
5. History of prior pancreatic surgery (this does not include endoscopic therapies)
6. Comorbid diseases characterized by a chronic inflammatory state, including, but not limited to rheumatologic diseases, chronic kidney disease, extra-pancreatic malignancy
7. Pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dose Escalation (DE) Phase; Here a traditional 3+3 design will be used to determine the compliance, tolerability and dose limiting toxicities in this unique patient population. Dose escalation with soy bread will be continued until dose-limiting toxicities are observed in >33% of the participants or the daily target dose of 4 slices of bread [132 mg soy isoflavone] is reached.	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.; Other Names: Soy Isoflavones
Experimental: Maximum Tolerated Dose (MTD) Phase; After the Phase I study has been completed, an additional 10 chronic pancreatitis patients will be treated at the best tolerated dose of soy bread for 4 weeks to further verify safety and toxicity.	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.; Other Names: Soy Isoflavones

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dose Limiting Toxicities	Participants were evaluated for the development of bothersome symptoms that prevented them from being able to complete the recommended intervention course. Counts represent number of subjects who developed a symptom that prevented the ability to complete the dose/study period.	1 (dose escalation groups) or 4 (maximally tolerated dose) weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pro-inflammatory Cytokines	Changes in the serum were assessed for TNF-alpha prior to and following introduction of soy bread	1 (dose escalation group) or 4 weeks (maximally tolerated subject)

Collaborators and Investigators

• Sponsor: Ohio State University
• Investigators: Principal Investigator: Philip Hart, MD, The Ohio State Wexner Medical Center

Publications and helpful links

General Publications

• Ahn-Jarvis J, Lombardo E, Cruz-Monserrate Z, Badi N, Crowe O, Kaul S, Komar H, Krishna SG, Lesinski GB, Mace TA, Ramsey ML, Roberts K, Stinehart K, Traczek M, Conwell DL, Vodovotz Y, Hart PA. Reduction of inflammation in chronic pancreatitis using a soy bread intervention: A feasibility study. Pancreatology. 2020 Jul;20(5):852-859. doi: 10.1016/j.pan.2020.04.018. Epub 2020 Jun 6.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: October 7, 2015
• First Submitted That Met QC Criteria: October 14, 2015
• First Posted (Estimate): October 16, 2015

Study Record Updates

• Last Update Posted (Actual): November 12, 2021
• Last Update Submitted That Met QC Criteria: October 15, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 2014H0226

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No