The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

Official title

The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial

Overview

This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.

Detailed description

Around 20% of patients with acute pancreatitis (AP) will go on to have acute recurrent pancreatitis (ARP) and 10% progress to chronic pancreatitis (CP). While interventions to avoid recurrences exist for the two most common causes - removal of the cholecyst in the case of biliary, and alcohol seccation in the case of alcoholic - a method to prevent idiopathic pancreatitis is not yet known. Although none of the guidelines suggest the administration of low fat diet, it is recommended by physicians to all pancreatitis patients are. Our aim is to conduct a randomized controlled trial, to assess the problem of dietary fat reduction on the recurrence of acute pancreatitis Patients, who had at least two acute pancreatitis episodes in the preceding 2 year will be approached to participate in the study and to either to be randomized to the 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) or to the 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations) group. During the 2 year long followup, participants will receive repeated dietary intervention at 3, 6, 12, 18, 24 months, they will completer food frequency questionnaires and their data regarding mortality, BMI, cardiovascular parameters and serum lipid values will be recorded The EFFORT trial will determine the effect of modified dietary fat content on the recurrence of AP, mortality, serum lipids and weight loss in idiopathic cases.

Interventions

• Behavioral Dietary intervention: reduced fat diet
  Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.
• Behavioral Dietary intervention: standard healthy diet
  Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.

Primary outcome measures

• Occurrence of recurrent acute pancreatitis and/or all-cause mortality [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]

Secondary outcome measures (12)

• Proportion of pancreas specific mortality [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]
• Proportion of cardiosvascular cause mortality [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]
• Proportion of newly diagnosed chronic pancreatitis patients [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]
• Changes in BMI [Time frame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits]
• Serum total cholesterol [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]
• Change in serum total cholesterol [Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]
• Serum triglyceride [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]
• Change in serum triglyceride [Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]
• Serum high density liporpotein(HDL)-cholesterol [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]
• Change in serum high density liporpotein(HDL)-cholesterol [Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]
• Serum low density liporpotein(LDL)-cholesterol [Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits]
• Change in serum low density liporpotein(LDL)-cholesterol [Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits]

Eligibility criteria

Inclusion criteria

• Individuals with at least two episodes of acute pancreatitis in the 2 years preceding the inclusion with
• The last episode being idiopathic, who are
• Older than 14 years.

Exclusion criteria

• Individuals already receiving regular nutritional guidance (with medical indication),
• Individuals in critical condition or in terminal stage of cancer (with an expected survival <2 years) ,
• Individuals undergoing treatment for active malignancy,
• Individuals with uncontrolled diabetes mellitus (admitted lack of compliance with antidiabetic therapy / HbA1c >6.5% / indication of uncontrolled diabetes mellitus in last 24 months' anamnesis / newly discovered diabetes mellitus)
• Individuals with known cholecystolithiasis
• Individuals who are pregnant or nursing
• Individuals with a BMI < 18.5
• Individuals who are regularly receiving systemic corticosteroids
• Individuals consuming more alcohol than: 5 units per day or 15 units per week for men; 4 units per day or 8 units per week for women.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Prevention

Study locations

Hungary · 1 center

• Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University — Budapest

Publications

• Spanier BW, Dijkgraaf MG, Bruno MJ. Epidemiology, aetiology and outcome of acute and chronic pancreatitis: An update. Best Pract Res Clin Gastroenterol. 2008;22(1):45-63. doi: 10.1016/j.bpg.2007.10.007. PMID 18206812
• Sankaran SJ, Xiao AY, Wu LM, Windsor JA, Forsmark CE, Petrov MS. Frequency of progression from acute to chronic pancreatitis and risk factors: a meta-analysis. Gastroenterology. 2015 Nov;149(6):1490-1500.e1. doi: 10.1053/j.gastro.2015.07.066. Epub 2015 Aug 20. PMID 26299411
• Working Group IAP/APA Acute Pancreatitis Guidelines. IAP/APA evidence-based guidelines for the management of acute pancreatitis. Pancreatology. 2013 Jul-Aug;13(4 Suppl 2):e1-15. doi: 10.1016/j.pan.2013.07.063. PMID 24054878
• Tenner S, Baillie J, DeWitt J, Vege SS; American College of Gastroenterology. American College of Gastroenterology guideline: management of acute pancreatitis. Am J Gastroenterol. 2013 Sep;108(9):1400-15; 1416. doi: 10.1038/ajg.2013.218. Epub 2013 Jul 30. PMID 23896955
• Crockett SD, Wani S, Gardner TB, Falck-Ytter Y, Barkun AN; American Gastroenterological Association Institute Clinical Guidelines Committee. American Gastroenterological Association Institute Guideline on Initial Management of Acute Pancreatitis. Gastroenterology. 2018 Mar;154(4):1096-1101. doi: 10.1053/j.gastro.2018.01.032. Epub 2018 Feb 3. No abstract available. PMID 29409760
• Prizment AE, Jensen EH, Hopper AM, Virnig BA, Anderson KE. Risk factors for pancreatitis in older women: the Iowa Women's Health Study. Ann Epidemiol. 2015 Jul;25(7):544-8. doi: 10.1016/j.annepidem.2014.12.010. Epub 2015 Jan 7. PMID 25656921
• Setiawan VW, Pandol SJ, Porcel J, Wei PC, Wilkens LR, Le Marchand L, Pike MC, Monroe KR. Dietary Factors Reduce Risk of Acute Pancreatitis in a Large Multiethnic Cohort. Clin Gastroenterol Hepatol. 2017 Feb;15(2):257-265.e3. doi: 10.1016/j.cgh.2016.08.038. Epub 2016 Sep 5. PMID 27609706
• Oskarsson V, Sadr-Azodi O, Discacciati A, Orsini N, Wolk A. Overall diet quality and risk of recurrence and progression of non-gallstone-related acute pancreatitis: a prospective cohort study. Eur J Nutr. 2018 Oct;57(7):2537-2545. doi: 10.1007/s00394-017-1526-8. Epub 2017 Aug 30. PMID 28856418

Identifiers

NCT: NCT04761523 · 40304-11/2020/EÜIG

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗