64 Participants Needed

Intermittent Fasting for Pancreatitis

(IFPanc Trial)

Recruiting at 1 trial location
SM
Overseen ByShaffer Mok
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does exclude patients who are on beta blockers.

What data supports the effectiveness of the treatment Intermittent Fasting for Pancreatitis?

Research shows that intermittent fasting, like alternate-day fasting, can help with weight loss and improve heart health in obese adults. Additionally, calorie restriction, a component of intermittent fasting, has been shown to delay the progression of pancreatic cancer in mice, suggesting potential benefits for pancreatic health.12345

Is intermittent fasting safe for humans?

Research on alternate-day fasting, a type of intermittent fasting, shows it is generally safe for weight loss and improving heart health in both obese and non-obese individuals. However, more data is needed on its long-term effects on hormones and metabolism.678910

How does intermittent fasting differ from other treatments for pancreatitis?

Intermittent fasting, such as alternate-day fasting, is unique because it involves cycles of eating very little on some days and eating normally on others, which may help manage pancreatitis by reducing inflammation and stress on the pancreas. Unlike traditional treatments that might focus on medication or continuous calorie restriction, this approach uses a specific eating schedule to potentially improve health outcomes.35111213

What is the purpose of this trial?

This trial is testing intermittent fasting to help people with recurrent acute and chronic pancreatitis. The fasting process releases fatty acids that turn into ketones, providing energy and reducing inflammation and scarring in the pancreas.

Eligibility Criteria

This trial is for adults aged 18 to 80 with recurrent acute pancreatitis or chronic pancreatitis, confirmed by specific diagnostic criteria. It's not suitable for pregnant individuals, those unable to consent, patients with certain types of pancreatitis (alcohol or gallstone-induced), pancreatic cancer, diabetes, on beta blockers, under 18 years old, with glycogen storage disease or active alcohol abuse.

Inclusion Criteria

Pancreatic exocrine insufficiency defined by a pancreatic elastase < 200 ug/g stool10
I have had more than 2 episodes of severe pancreatitis.
My chronic pancreatitis is confirmed by specific tests or scans.

Exclusion Criteria

I have diabetes.
I am under 18 years old.
I am currently taking beta blockers.
See 9 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants follow either an intermittent fasting regimen or a standard diet approach for 24 weeks

24 weeks
Regular monitoring visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Intermittent Fasting
  • No intermittent fasting
Trial Overview The study aims to see if intermittent fasting can improve life quality and reduce hospital visits compared to a standard diet in people with pancreas-related diseases. Participants will be assigned either to try intermittent fasting or continue their usual diet.
Participant Groups
2Treatment groups
Experimental Treatment
Active Control
Group I: Intermittent FastingExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

H. Lee Moffitt Cancer Center and Research Institute

Lead Sponsor

Trials
576
Recruited
145,000+

Findings from Research

Modified alternate-day fasting (ADF) led to significant weight loss (5.6 kg) and reduced body fat percentage in 16 obese adults over 8 weeks, demonstrating its efficacy as a weight management strategy.
ADF also improved cardiovascular health indicators, with notable reductions in total cholesterol, LDL cholesterol, and triglycerides, suggesting it may lower the risk of coronary artery disease.
Short-term modified alternate-day fasting: a novel dietary strategy for weight loss and cardioprotection in obese adults.Varady, KA., Bhutani, S., Church, EC., et al.[2023]
In a pilot study involving 105 male SCID mice with prostate cancer, intermittent fasting regimens showed non-significant trends toward improved survival compared to a control group, suggesting potential benefits of fasting in cancer management.
Mice on certain fasting diets had significantly lower body weights and IGF-1 levels, indicating that these dietary interventions may influence cancer growth mechanisms, although no significant survival differences were observed.
Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice.Buschemeyer, WC., Klink, JC., Mavropoulos, JC., et al.[2010]
In an 8-week study with 59 obese participants, alternate day fasting (ADF) led to a significant weight loss of 4.2%, while only a small percentage reported mild adverse effects like constipation and dizziness.
ADF was associated with improvements in eating disorder symptoms, including a decrease in depression and binge eating, suggesting that it may have beneficial effects on body image and eating behaviors.
Safety of alternate day fasting and effect on disordered eating behaviors.Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

References

Short-term modified alternate-day fasting: a novel dietary strategy for weight loss and cardioprotection in obese adults. [2023]
Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice. [2010]
Calorie restriction delays the progression of lesions to pancreatic cancer in the LSL-KrasG12D; Pdx-1/Cre mouse model of pancreatic cancer. [2022]
Effects of alternate-day fasting or daily calorie restriction on body composition, fat distribution, and circulating adipokines: Secondary analysis of a randomized controlled trial. [2020]
Changes in hunger and fullness in relation to gut peptides before and after 8 weeks of alternate day fasting. [2018]
Safety of alternate day fasting and effect on disordered eating behaviors. [2018]
Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. [2022]
A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. [2019]
Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Effect of alternate-day fasting on obesity and cardiometabolic risk: A systematic review and meta-analysis. [2020]
Eating behavior traits of successful weight losers during 12 months of alternate-day fasting: An exploratory analysis of a randomized controlled trial. [2020]
Beverage intake during alternate-day fasting: Relationship to energy intake and body weight. [2022]
The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. [2022]
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