Intermittent Fasting for Pancreatitis

NCT04760847 | Not Yet Recruiting DMC

• 1 other identifier: STUDY20201373
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research is to compare intermittent fasting with a standard diet approach for improving the quality of life related to your pancreas disease. Our hope is to improve your symptoms and prevent you from needing to go into the hospital for pancreas-related issues.

Conditions

Pancreatitis; Pancreatitis, Acute; Pancreatitis, Chronic; Pancreas Disease; Acute Recurrent Pancreatitis

Keywords

pancreatitis; acute pancreatitis; acute recurrent pancreatitis; chronic pancreatitis; fasting; intermittent fasting

Outcome Measures

Primary Outcomes (1)

• Pancreas related Quality of Life Index (PANQALI)

  Pancreas related Quality of Life Index (PANQALI) is pancreas related quality of life index scale from 0 (lowest or better disease activity) to 90 (highest or worse disease activity)

  24 weeks

Secondary Outcomes (8)

• Pain scores

  24 weeks

• Oral Morphine Equivalent Daily Dosing

  24 weeks

• Patient weight

  24 weeks

• Patient Body mass index

  24 weeks

• Vitamin D 25-OH levels

  24 weeks

Study Arms (2)

Intermittent Fasting

EXPERIMENTAL

Patients in Group A will then receive information regarding intermittent fasting, which would include fasting for a 16-hour period each day, followed by ingestion of an appropriate number of calories for the remaining part of the day.

Other: Intermittent Fasting

Control

ACTIVE COMPARATOR

These subjects will undergo standard caloric dietary guidance. Patients in group B will also be given the above information, though not be asked to intermittently fast.

Other: No intermittent fasting

Interventions

Intermittent Fasting OTHER

These subjects will will then receive information regarding intermittent fasting, which would include fasting for a 16-hour period each day, followed by ingestion of an appropriate number of calories for the remaining part of the day. See attached IF Quick Facts for details provided to the patient.

Intermittent Fasting

No intermittent fasting OTHER

These subjects will undergo standard caloric dietary guidance. Patients in group B will also be given the above information, though not be asked to intermittently fast

Control

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 year
• Recurrent acute pancreatitis defined by greater than 2 episodes of pancreatitis, defined by:
• abdominal pain and either amylase or lipase \> 3 x the upper limit of normal, imaging suggestive of, separated by time
• Anatomy of chronic pancreatitis defined by Rosemont criterion9 or on imaging (CT, MRI)
• Pancreatic exocrine insufficiency defined by a pancreatic elastase \< 200 ug/g stool10

You may not qualify if:

• Age \< 18 years
• Pregnant Patients
• Age \> 80 years
• Patients who cannot consent for themselves
• Glycogen storage disease
• Insulinoma or hypoglycemic state
• Active alcohol abuse
• Alcohol induced acute pancreatitis
• Gallstone induced acute pancreatitis
• Pancreatic solid neoplasm
• Patients with diabetes
• Patients on beta blockers

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead

Study Sites (1)

Moffitt Cancer Center

Tampa, Florida, 33612, United States

Location

Related Publications (15)

• Wassef W, DeWitt J, McGreevy K, Wilcox M, Whitcomb D, Yadav D, Amann S, Mishra G, Alkaade S, Romagnuolo J, Stevens T, Vargo J, Gardner T, Singh V, Park W, Hartigan C, Barton B, Bova C. Pancreatitis Quality of Life Instrument: A Psychometric Evaluation. Am J Gastroenterol. 2016 Aug;111(8):1177-86. doi: 10.1038/ajg.2016.225. Epub 2016 Jun 14.

  PMID: 27296943 BACKGROUND

• Crozier SJ, Sans MD, Guo L, D'Alecy LG, Williams JA. Activation of the mTOR signalling pathway is required for pancreatic growth in protease-inhibitor-fed mice. J Physiol. 2006 Jun 15;573(Pt 3):775-86. doi: 10.1113/jphysiol.2006.106914. Epub 2006 Apr 13.

  PMID: 16613881 BACKGROUND

• Yang J, Waldron RT, Su HY, Moro A, Chang HH, Eibl G, Ferreri K, Kandeel FR, Lugea A, Li L, Pandol SJ. Insulin promotes proliferation and fibrosing responses in activated pancreatic stellate cells. Am J Physiol Gastrointest Liver Physiol. 2016 Oct 1;311(4):G675-G687. doi: 10.1152/ajpgi.00251.2016. Epub 2016 Sep 8.

  PMID: 27609771 BACKGROUND

• Bellizzi AM, Bloomston M, Zhou XP, Iwenofu OH, Frankel WL. The mTOR pathway is frequently activated in pancreatic ductal adenocarcinoma and chronic pancreatitis. Appl Immunohistochem Mol Morphol. 2010 Oct;18(5):442-7. doi: 10.1097/PAI.0b013e3181de115b.

  PMID: 20661135 BACKGROUND

• Javle MM, Shroff RT, Xiong H, Varadhachary GA, Fogelman D, Reddy SA, Davis D, Zhang Y, Wolff RA, Abbruzzese JL. Inhibition of the mammalian target of rapamycin (mTOR) in advanced pancreatic cancer: results of two phase II studies. BMC Cancer. 2010 Jul 14;10:368. doi: 10.1186/1471-2407-10-368.

  PMID: 20630061 BACKGROUND

• Law R, Leal C, Dayyeh BA, Leise MD, Balderramo D, Baron TH, Cardenas A. Role of immunosuppression in post-endoscopic retrograde cholangiopancreatography pancreatitis after liver transplantation: a retrospective analysis. Liver Transpl. 2013 Dec;19(12):1354-60. doi: 10.1002/lt.23758.

  PMID: 24115362 BACKGROUND

• Ji L, Li L, Qu F, Zhang G, Wang Y, Bai X, Pan S, Xue D, Wang G, Sun B. Hydrogen sulphide exacerbates acute pancreatitis by over-activating autophagy via AMPK/mTOR pathway. J Cell Mol Med. 2016 Dec;20(12):2349-2361. doi: 10.1111/jcmm.12928. Epub 2016 Jul 15.

  PMID: 27419805 BACKGROUND

• Wu XM, Ji KQ, Wang HY, Zhao Y, Jia J, Gao XP, Zang B. MicroRNA-339-3p alleviates inflammation and edema and suppresses pulmonary microvascular endothelial cell apoptosis in mice with severe acute pancreatitis-associated acute lung injury by regulating Anxa3 via the Akt/mTOR signaling pathway. J Cell Biochem. 2018 Aug;119(8):6704-6714. doi: 10.1002/jcb.26859. Epub 2018 Apr 25.

  PMID: 29693276 BACKGROUND

• Conwell DL, Lee LS, Yadav D, Longnecker DS, Miller FH, Mortele KJ, Levy MJ, Kwon R, Lieb JG, Stevens T, Toskes PP, Gardner TB, Gelrud A, Wu BU, Forsmark CE, Vege SS. American Pancreatic Association Practice Guidelines in Chronic Pancreatitis: evidence-based report on diagnostic guidelines. Pancreas. 2014 Nov;43(8):1143-62. doi: 10.1097/MPA.0000000000000237.

  PMID: 25333398 BACKGROUND

• Herzig KH, Purhonen AK, Rasanen KM, Idziak J, Juvonen P, Phillps R, Walkowiak J. Fecal pancreatic elastase-1 levels in older individuals without known gastrointestinal diseases or diabetes mellitus. BMC Geriatr. 2011 Jan 25;11:4. doi: 10.1186/1471-2318-11-4.

  PMID: 21266058 BACKGROUND

• Han S, Patel B, Min M, Bocelli L, Kheder J, Wachholtz A, Wassef W. Quality of life comparison between smokers and non-smokers with chronic pancreatitis. Pancreatology. 2018 Apr;18(3):269-274. doi: 10.1016/j.pan.2018.02.012. Epub 2018 Feb 26.

  PMID: 29500114 BACKGROUND

• Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.

  PMID: 26977696 BACKGROUND

• Ferguson ND, Fan E, Camporota L, Antonelli M, Anzueto A, Beale R, Brochard L, Brower R, Esteban A, Gattinoni L, Rhodes A, Slutsky AS, Vincent JL, Rubenfeld GD, Thompson BT, Ranieri VM. The Berlin definition of ARDS: an expanded rationale, justification, and supplementary material. Intensive Care Med. 2012 Oct;38(10):1573-82. doi: 10.1007/s00134-012-2682-1. Epub 2012 Aug 25.

  PMID: 22926653 BACKGROUND

• Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.

  PMID: 20189503 BACKGROUND

• Corley BT, Carroll RW, Hall RM, Weatherall M, Parry-Strong A, Krebs JD. Intermittent fasting in Type 2 diabetes mellitus and the risk of hypoglycaemia: a randomized controlled trial. Diabet Med. 2018 May;35(5):588-594. doi: 10.1111/dme.13595. Epub 2018 Feb 27.

  PMID: 29405359 BACKGROUND

MeSH Terms

Conditions

Pancreatitis; Pancreatitis, Chronic; Pancreatic Diseases; Fasting; Intermittent Fasting

Condition Hierarchy (Ancestors)

Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Feeding Behavior; Behavior

Central Study Contacts

Shaffer Mok

CONTACT

6099804564; mok.shaffer@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The control group will have 32 patients and the group undergoing IF will have 32 patients (for both recurrent acute and chronic pancreatitis); the randomization is 1:1; IF versus control. Sixty four subjects will be enrolled at UH for a total of 64 subjects.

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 18, 2021
• Study Start: March 1, 2026
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: April 22, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)