Intermittent Fasting for Pancreatitis

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorH. Lee Moffitt Cancer Center and Research Institute

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 year

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

Disqualifiers

Age < 18 years

Pregnant Patients

Age > 80 years

Patients who cannot consent for themselves

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intermittent Fasting

    Other intervention

    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.

  • No intermittent fasting

    Other intervention

    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

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Intermittent FastingExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

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)

Time frame
24 weeks

Secondary outcomes

1

Pain scores

standard score from 0-10 (0 no pain, 10 worst pain)

Time frame
24 weeks
2

Oral Morphine Equivalent Daily Dosing

total dose of opiates taken converted into morphine in milligrams

Time frame
24 weeks
3

Patient weight

pounds

Time frame
24 weeks
4

Patient Body mass index

pounds/inch squared

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: