Intermittent Fasting for Pancreatitis (IFPanc)
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|ClinicalTrials.gov Identifier: NCT04760847|
Recruitment Status : Not yet recruiting
First Posted : February 18, 2021
Last Update Posted : July 7, 2022
|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|
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
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||64 participants|
|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)|
|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|
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
- 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)
- Pain scores [ Time Frame: 24 weeks ]standard score from 0-10 (0 no pain, 10 worst pain)
- Oral Morphine Equivalent Daily Dosing [ Time Frame: 24 weeks ]total dose of opiates taken converted into morphine in milligrams
- Patient weight [ Time Frame: 24 weeks ]pounds
- Patient Body mass index [ Time Frame: 24 weeks ]pounds/inch squared
- Vitamin D 25-OH levels [ Time Frame: 24 weeks ]levels of vitamin D 25-OH in nanograms/milliLiter
- stool pancreatic elastase levels [ Time Frame: 24 weeks ]stool elastase level in micrograms/gram
- Readmissions [ Time Frame: 24 weeks ]number of participants that need to seek medical care
- Length of Stay [ Time Frame: 24 weeks ]days requiring medical care
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
|Contact: Shaffer Mokfirstname.lastname@example.org|
|United States, Florida|
|Moffitt Cancer Center|
|Tampa, Florida, United States, 33612|
|Contact: Shaffer Mok, MD 609-980-4564 Shaffer.Mok@moffitt.org|