Intermittent Fasting for Pancreatitis

(IFPanc Trial)

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

64 Participants Needed

What You Need to Know Before You Apply

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.

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 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. ^{1 2 3 4 5}

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. ^{6 7 8 9 10}

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. ^{8 9 11 12 13}

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

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.

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

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 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]

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]

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 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 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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Short-term modified alternate-day fasting: a novel dietary strategy for weight loss and cardioprotection in obese adults. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of intermittent fasting with or without caloric restriction on prostate cancer growth and survival in SCID mice. [2010]

3. England pubmed.ncbi.nlm.nih.gov

Calorie restriction delays the progression of lesions to pancreatic cancer in the LSL-KrasG12D; Pdx-1/Cre mouse model of pancreatic cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

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]

5. England pubmed.ncbi.nlm.nih.gov

Changes in hunger and fullness in relation to gut peptides before and after 8 weeks of alternate day fasting. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Safety of alternate day fasting and effect on disordered eating behaviors. [2018]

7. United States 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. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

A randomized pilot study comparing zero-calorie alternate-day fasting to daily caloric restriction in adults with obesity. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Alternate day fasting for weight loss in normal weight and overweight subjects: a randomized controlled trial. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Effect of alternate-day fasting on obesity and cardiometabolic risk: A systematic review and meta-analysis. [2020]

11. England 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. [2020]

12. England pubmed.ncbi.nlm.nih.gov

Beverage intake during alternate-day fasting: Relationship to energy intake and body weight. [2022]

13. England 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. [2022]