An interventional study of Intermittent Fasting and No intermittent fasting in Pancreatitis, Pancreatitis, Acute and Pancreatitis, Chronic, sponsored by H. Lee Moffitt Cancer Center and Research Institute. Not yet recruiting at 1 site in United States. Open to participants aged 18 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-17.
Sponsored by H. Lee Moffitt Cancer Center and Research Institute · Not applicable, Interventional, and Treatment
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.
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
264 studies on the registry are indexed under Pancreatitis, Chronic; 76 are open to participants now.
This study's planned enrollment of 64 is above the median of 45 across 143 interventional studies indexed under Pancreatitis, Chronic.
Browse Pancreatitis, Chronic studies →H. Lee Moffitt Cancer Center and Research Institute is the lead sponsor of 540 studies on the registry; 75 are open to participants now.
Of its 99 completed or terminated interventional studies of FDA-regulated products, 57 (58%) have results posted.
Compared within Pancreatitis, Chronic, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Pancreatitis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
abdominal pain and either amylase or lipase > 3 x the , imaging suggestive of, separated by time
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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 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.
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)
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
Pain scores
standard score from 0-10 (0 no pain, 10 worst pain)
Time frame: 24 weeks
Oral Morphine Equivalent Daily Dosing
total dose of opiates taken converted into morphine in milligrams
Time frame: 24 weeks
Patient weight
pounds
Time frame: 24 weeks
Patient Body mass index
pounds/inch squared
Time frame: 24 weeks
Vitamin D 25-OH levels
levels of vitamin D 25-OH in nanograms/milliLiter
Time frame: 24 weeks
stool pancreatic elastase levels
stool elastase level in micrograms/gram
Time frame: 24 weeks
Readmissions
number of participants that need to seek medical care
Time frame: 24 weeks
Length of Stay
days requiring medical care
Time frame: 24 weeks
Plan to share: No
Start is estimated for Sep 2027; primary completion for Mar 2030, 30 months later.
Of 46 non-industry interventional studies with no phase under Pancreatitis, Chronic, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 64. This study's planned 30 months is close to that.
Counting every sponsor, half of 49 studies reached it within 32 months; a quarter within 18 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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H. Lee Moffitt Cancer Center and Research Institute →