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Intermittent Fasting for Pancreatitis (IFPanc)

Primary Purpose

Pancreatitis, Pancreatitis, Acute, Pancreatitis, Chronic

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intermittent Fasting
No intermittent fasting
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring pancreatitis, acute pancreatitis, acute recurrent pancreatitis, chronic pancreatitis, fasting, intermittent fasting

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Moffitt Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intermittent Fasting

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Pain scores
standard score from 0-10 (0 no pain, 10 worst pain)
Oral Morphine Equivalent Daily Dosing
total dose of opiates taken converted into morphine in milligrams
Patient weight
pounds
Patient Body mass index
pounds/inch squared
Vitamin D 25-OH levels
levels of vitamin D 25-OH in nanograms/milliLiter
stool pancreatic elastase levels
stool elastase level in micrograms/gram
Readmissions
number of participants that need to seek medical care
Length of Stay
days requiring medical care

Full Information

First Posted
February 15, 2021
Last Updated
July 24, 2023
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04760847
Brief Title
Intermittent Fasting for Pancreatitis
Acronym
IFPanc
Official Title
Intermittent Fasting as a Primary Means for Improving Quality of Life for Acute and Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 7, 2023 (Anticipated)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Pancreatitis, Acute, Pancreatitis, Chronic, Pancreas Disease, Acute Recurrent Pancreatitis
Keywords
pancreatitis, acute pancreatitis, acute recurrent pancreatitis, chronic pancreatitis, fasting, intermittent fasting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intermittent Fasting
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Intermittent Fasting
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No intermittent fasting
Intervention Description
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 Measure Information:
Title
Pancreas related Quality of Life Index (PANQALI)
Description
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)
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Pain scores
Description
standard score from 0-10 (0 no pain, 10 worst pain)
Time Frame
24 weeks
Title
Oral Morphine Equivalent Daily Dosing
Description
total dose of opiates taken converted into morphine in milligrams
Time Frame
24 weeks
Title
Patient weight
Description
pounds
Time Frame
24 weeks
Title
Patient Body mass index
Description
pounds/inch squared
Time Frame
24 weeks
Title
Vitamin D 25-OH levels
Description
levels of vitamin D 25-OH in nanograms/milliLiter
Time Frame
24 weeks
Title
stool pancreatic elastase levels
Description
stool elastase level in micrograms/gram
Time Frame
24 weeks
Title
Readmissions
Description
number of participants that need to seek medical care
Time Frame
24 weeks
Title
Length of Stay
Description
days requiring medical care
Time Frame
24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shaffer Mok
Phone
6099804564
Email
mok.shaffer@gmail.com
Facility Information:
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaffer Mok, MD
Phone
609-980-4564
Email
Shaffer.Mok@moffitt.org

12. IPD Sharing Statement

Plan to Share IPD
No
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Intermittent Fasting for Pancreatitis

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