Dietary Soy Isoflavones In Chronic Pancreatitis

NCT02577640 | Completed Results

• 1 other identifier: 2014H0226
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Pro-inflammatory Cytokines

  1 (dose escalation group) or 4 weeks (maximally tolerated subject)

Study Arms (2)

Dose Escalation (DE) Phase

EXPERIMENTAL

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

Maximum Tolerated Dose (MTD) Phase

EXPERIMENTAL

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

Interventions

Soy bread DIETARY_SUPPLEMENT

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.

Also known as: Soy Isoflavones

Dose Escalation (DE) Phase; Maximum Tolerated Dose (MTD) Phase

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chronic pancreatitis by fulfilling one of the following clinical scenarios:
• Presence of pancreatic calcifications
• Suggestive for chronic pancreatitis - consistent EUS criteria or at least 3 abnormal side branches on pancreatic duct imaging
• Indeterminate EUS findings for chronic pancreatitis with evidence of exocrine pancreatic insufficiency (EPI)
• Age ≥18 years

You may not qualify if:

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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

Philip Hart

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 32595109 BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Soybean Proteins

Condition Hierarchy (Ancestors)

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Results Point of Contact

• Title: Casey McClurkin
• Organization: Ohio State University

casey.mclurkin@osumc.edu

614-293-6255

Study Officials

• Philip Hart, MD

  The Ohio State Wexner Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor-Clinical

Study Record Dates

• First Submitted: October 7, 2015
• First Posted: October 16, 2015
• Study Start: July 1, 2015
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: November 12, 2021
• Results First Posted: November 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)