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Intermittent Fasting for Pancreatitis (IFPanc)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04760847
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute

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.

Condition or disease Intervention/treatment Phase
Pancreatitis Pancreatitis, Acute Pancreatitis, Chronic Pancreas Disease Acute Recurrent Pancreatitis Other: Intermittent Fasting Other: No intermittent fasting Not Applicable

Detailed Description:

Fasting is a classic means for religious discipline, yet recently regaining favor in the medical landscape. Numerous studies have come forth, both in animals and humans outlining the benefit of intermittent fasting (IF) on various disease states and longevity. Though a relatively complex cellular process, fasting for at least 8-12 hours has been shown to lead to fatty acid release from a patient's adipose storage. These fatty acids then shuttle to the liver, where they are converted to ketones such as beta-hydroxybutyrate and acetoacetate.

Ketones are then utilized for energy sources in the heart, brain and skeletal muscle tissue. The energy produced (ATP), then leads to increase in the cellular powerhouses, the mitochondria and autophagy or cell recycling. This cellular recycling is one main way in which IF has proven benefit for inflammatory conditions and in cancer care.

Furthermore, reductions in amino acids and glucose due to fasting and reliance on ketones as energy, lead to down regulation of the membrane target of rapamycin (mTOR) pathway. Much is known regarding the mTOR pathway. Down regulation of mTOR is associated with increased autophagy (as above), lower protein and lipid synthesis, ribosome and lysosome creation (cell shuttles) and lowered energy use.

Specific to the pancreas, mTOR down regulation has been shown to lower protein synthesis with the pancreas, caused by cholecystokinin (CCK), a pancreas stimulating hormone.2 The effect of this leads to lower pancreatic enzymes secretion. Inhibition of mTOR also lowers the generation of fibroblasts, the scar-tissue cells within the pancreas, leading to less scar-formation.3 Scar tissue formation is a vital part of morbidity and complications for patients with chronic pancreatitis.

Pancreatic disease-modulation has also been evaluated in regard to the mTOR pathway.4 For pancreatic cancer, rapamycin a mTOR inhibitor have been implicated as targets for chemotherapy. Clinical trials have shown benefit for pancreatic cancer cases given rapamycin in concert with other chemotherapeutic medications.5 For acute, chronic pancreatitis and post-ndoscopic retrograde cholangiopancreatopgraphy (ERCP) pancreatitis, mTOR is usually activated.6 In particular, blocking the mTOR pathway can favor autophagy, limit cell death (apoptosis) and hence necrosis of the pancreas. Necrosis in pancreatitis, leads to complex disease, possess a higher mortality, organ failure, and can make the clinical course more complicated. Therefore, the mTOR pathway has been implicated as a potential therapeutic target to ameliorate disease course and severity.4,7,8 The purpose of this study is to evaluate IF as a means for limiting disease severity with people who have recurrent acute pancreatitis and chronic pancreatitis. Our hypothesis is that IF will improve pancreatic-disease related quality of life.1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intermittent Fasting as a Primary Means for Improving Quality of Life for Acute and Chronic Pancreatitis
Estimated Study Start Date : January 7, 2023
Estimated Primary Completion Date : February 1, 2024
Estimated Study Completion Date : February 1, 2024


Arm Intervention/treatment
Experimental: Intermittent Fasting
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
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.

Active Comparator: Control
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
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




Primary Outcome Measures :
  1. Pancreas related Quality of Life Index (PANQALI) [ Time Frame: 24 weeks ]
    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)


Secondary Outcome Measures :
  1. Pain scores [ Time Frame: 24 weeks ]
    standard score from 0-10 (0 no pain, 10 worst pain)

  2. Oral Morphine Equivalent Daily Dosing [ Time Frame: 24 weeks ]
    total dose of opiates taken converted into morphine in milligrams

  3. Patient weight [ Time Frame: 24 weeks ]
    pounds

  4. Patient Body mass index [ Time Frame: 24 weeks ]
    pounds/inch squared

  5. Vitamin D 25-OH levels [ Time Frame: 24 weeks ]
    levels of vitamin D 25-OH in nanograms/milliLiter

  6. stool pancreatic elastase levels [ Time Frame: 24 weeks ]
    stool elastase level in micrograms/gram

  7. Readmissions [ Time Frame: 24 weeks ]
    number of participants that need to seek medical care

  8. Length of Stay [ Time Frame: 24 weeks ]
    days requiring medical care



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04760847


Contacts
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Contact: Shaffer Mok 6099804564 mok.shaffer@gmail.com

Locations
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United States, Florida
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Contact: Shaffer Mok, MD    609-980-4564    Shaffer.Mok@moffitt.org   
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Publications:

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Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT04760847    
Other Study ID Numbers: STUDY20201373
First Posted: February 18, 2021    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: January 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
pancreatitis
acute pancreatitis
acute recurrent pancreatitis
chronic pancreatitis
fasting
intermittent fasting
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases