Intermittent Fasting for Pancreatitis

(IFPanc Trial)

Not yet recruiting at 1 trial location

Overseen By Shaffer Mok

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Must not be taking: Beta blockers

Disqualifiers: Diabetes, Active alcohol abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether intermittent fasting can improve the quality of life for individuals with pancreas disease, specifically those with recurring acute pancreatitis. It compares a daily fasting routine, where participants fast for 16 hours and eat during the remaining 8 hours, to a standard diet without fasting. The goal is to ease symptoms and reduce hospital visits related to pancreas problems. Candidates may be suitable if they have experienced more than two episodes of pancreatitis, have ongoing pancreas issues, and are not affected by conditions like diabetes or alcohol-related pancreatitis. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance future treatment options.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that intermittent fasting is generally safe for most people. This eating pattern can aid in weight control and improve blood sugar levels. For instance, a study with 405 adults found that a specific type of intermittent fasting improved blood sugar control more effectively than some common diabetes medications. Although intermittent fasting involves not eating for certain periods, most people manage it well. However, consulting a healthcare provider before starting any new diet is crucial, especially for those with medical conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about intermittent fasting for pancreatitis because it offers a novel approach compared to traditional dietary management, which typically involves standard caloric guidance and careful monitoring of fat intake. Unlike these conventional methods, intermittent fasting involves fasting for 16 hours each day, potentially reducing inflammation and allowing the pancreas to heal by minimizing digestive strain. This approach is gaining attention as it could offer a more natural, less medication-dependent way to manage pancreatitis symptoms and improve overall pancreatic health.

What evidence suggests that intermittent fasting could be an effective treatment for pancreatitis?

Research has shown that intermittent fasting, which participants in this trial may follow, can aid in weight loss and blood sugar control. For example, one study found that a 5:2 intermittent fasting diet improved blood sugar levels more effectively than some diabetes medications. Another study found that a modified alternate-day fasting plan helped obese adults lose about 5.6 kg (about 12 pounds) in just 8 weeks. These improvements in weight and blood sugar are important because they can reduce stress on the pancreas, potentially alleviating symptoms of pancreatitis (inflammation of the pancreas). Although direct evidence that intermittent fasting specifically helps with pancreatitis is not yet available, these benefits suggest it could be helpful in managing the condition. Participants in the control arm of this trial will receive standard caloric dietary guidance without intermittent fasting. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

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

My chronic pancreatitis is confirmed by specific tests or scans.

I have had more than 2 episodes of severe pancreatitis.

Exclusion Criteria

I have diabetes.

I am under 18 years old.

I am currently taking beta blockers.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Intermittent Fasting Experimental Treatment 1 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: Control Active Control 1 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.

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+

Published Research Related to This Trial

A study is being conducted to explore the effects of alternate day fasting (ADF) on healthy non-obese individuals, involving 90 participants, with some having followed ADF for at least 6 months and others starting ADF for 4 weeks.

The research aims to assess various health parameters, including metabolic and cardiovascular effects, using advanced techniques like echocardiography and glucose monitoring, to better understand the physiological impacts of ADF.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intermittent Fasting (Alternate Day Fasting) in Healthy, Non-obese Adults: Protocol for a Cohort Trial with an Embedded Randomized Controlled Pilot Trial. Tripolt, NJ., Stekovic, S., Aberer, F., et al.[2022]

Alternate-day fasting (ADF) is a safe and well-tolerated weight loss method, with 93% of participants completing the 8-week study without adverse effects.

While ADF and a standard caloric restriction diet produced similar weight loss results after 8 weeks, ADF showed more favorable changes in body composition, particularly in fat and lean mass, during the follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. Catenacci, VA., Pan, Z., Ostendorf, D., et al.[2019]

In a study involving 32 participants over six weeks, the Time-restricted Feeding (TRF) diet was found to be the most acceptable, with participants reporting it as the easiest to follow compared to Early Time-restricted Feeding (eTRF) and Alternate Day Fasting (ADF).

Despite differences in dietary acceptability, there were no significant differences in weight loss or energy intake among the three fasting protocols, indicating that adherence may be more influenced by personal preference than by the specific diet's effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Fasting and Shifted Timing (FAST) of Eating Study: A pilot feasibility randomized crossover intervention assessing the acceptability of three different fasting diet approaches. Turner-McGrievy, GM., Wirth, MD., Bernhart, JA., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. Hoddy, KK., Kroeger, CM., Trepanowski, JF., et al.[2018]

In a study of 32 non-obese individuals over 12 weeks, alternate day fasting (ADF) led to a significant weight loss of 5.2 kg (6.5%) and a reduction in fat mass without affecting fat-free mass, indicating its efficacy for weight management.

ADF also improved cardiovascular risk factors, as evidenced by decreased triacylglycerol levels, increased LDL particle size, and changes in adipokine levels, suggesting potential cardio-protective benefits in normal weight and overweight adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. Varady, KA., Bhutani, S., Klempel, MC., et al.[2021]

In a 12-month study involving 34 obese participants, those who lost 5% or more of their body weight on alternate-day fasting (ADF) reported feeling fuller and less hungry, indicating improved satiety.

Successful weight losers on ADF also increased their dietary protein intake from 15% to 20% of their total calories and showed better adherence to calorie goals on fasting days, suggesting effective behavioral changes associated with this diet.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Eating behavior traits of successful weight losers during 12 months of alternate-day fasting: An exploratory analysis of a randomized controlled trial. Kroeger, CM., Trepanowski, JF., Klempel, MC., et al.[2020]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9946909/

Beneficial effects of intermittent fasting: a narrative review In this review, we evaluate the results mainly from ADF and 5:2 diet trials. Weight reduction is the primary mechanism underlying the beneficial effects of IF.

2. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2820237

A 5:2 Intermittent Fasting Meal Replacement Diet and ... In this randomized clinical trial of 405 adults, the 5:2 MR approach achieved better glycemic control at 16 weeks compared with metformin and empagliflozin.

3. withpower.com withpower.com/trial/phase-pancreatic-diseases-2-2021-fdf04

Intermittent Fasting for Pancreatitis (IFPanc Trial) 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 ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2114833

Calorie Restriction with or without Time-Restricted Eating ... In this 12-month trial, we found that the 8-hour time-restricted–eating regimen did not produce greater weight loss than the regimen of daily ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8766278/

Effects of intermittent (5:2) or continuous energy restriction ... However, 5:2 IER resulted in greater improvements in fasting blood glucose, and beneficial changes in fasting subjective appetite ratings.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9650338/

Intermittent fasting and time-restricted eating role in dietary ... Based on the current evidence, it appears that both caloric restriction and timing of meals are critical to weight loss and that time-restricted ...

7. nature.com nature.com/articles/s41430-021-00909-2

Effects of intermittent (5:2) or continuous energy restriction ... However, 5:2 IER resulted in greater improvements in fasting blood glucose, and beneficial changes in fasting subjective appetite ratings.