The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

NCT04761523 | Recruiting DMC

• 1 other identifier: 40304-11/2020/EÜIG
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute Pancreatitis

Keywords

acute pancreatitis; dietary fat; low-fat diet; pancreatitis recurrence

Outcome Measures

Primary Outcomes (1)

• Occurrence of recurrent acute pancreatitis and/or all-cause mortality

  The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality.

  Data will be recorded during the 3-6-12-18-24 months followup visits

Secondary Outcomes (34)

• Proportion of pancreas specific mortality

  Data will be recorded during the 3-6-12-18-24 months followup visits

• Proportion of cardiosvascular cause mortality

  Data will be recorded during the 3-6-12-18-24 months followup visits

• Proportion of newly diagnosed chronic pancreatitis patients

  Data will be recorded during the 3-6-12-18-24 months followup visits

• Changes in BMI

  Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits

• Serum total cholesterol

  Data will be recorded during the 3-6-12-18-24 months followup visits

Study Arms (2)

Reduced fat arm

ACTIVE COMPARATOR

Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins

Behavioral: Dietary intervention: reduced fat diet

Standard healthy diet arm

ACTIVE COMPARATOR

Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins.

Behavioral: Dietary intervention: standard healthy diet

Interventions

Dietary intervention: reduced fat diet BEHAVIORAL

Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.

Reduced fat arm

Dietary intervention: standard healthy diet BEHAVIORAL

Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.

Standard healthy diet arm

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• The last episode being idiopathic, who are
• Older than 14 years.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Pecs: lead

Study Sites (1)

Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University

Budapest, Hungary

RECRUITING

Related Publications (26)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Cuevas A, Miquel JF, Reyes MS, Zanlungo S, Nervi F. Diet as a risk factor for cholesterol gallstone disease. J Am Coll Nutr. 2004 Jun;23(3):187-96. doi: 10.1080/07315724.2004.10719360.

  PMID: 15190042 BACKGROUND

• Thomas T, Mah L, Barreto SG. Systematic review of diet in the pathogenesis of acute pancreatitis: a tale of too much or too little? Saudi J Gastroenterol. 2012 Sep-Oct;18(5):310-5. doi: 10.4103/1319-3767.101124.

  PMID: 23006458 BACKGROUND

• Lindkvist B, Appelros S, Regner S, Manjer J. A prospective cohort study on risk of acute pancreatitis related to serum triglycerides, cholesterol and fasting glucose. Pancreatology. 2012 Jul-Aug;12(4):317-24. doi: 10.1016/j.pan.2012.05.002. Epub 2012 May 10.

  PMID: 22898632 BACKGROUND

• Cappell MS. Acute pancreatitis: etiology, clinical presentation, diagnosis, and therapy. Med Clin North Am. 2008 Jul;92(4):889-923, ix-x. doi: 10.1016/j.mcna.2008.04.013.

  PMID: 18570947 BACKGROUND

• Biczo G, Vegh ET, Shalbueva N, Mareninova OA, Elperin J, Lotshaw E, Gretler S, Lugea A, Malla SR, Dawson D, Ruchala P, Whitelegge J, French SW, Wen L, Husain SZ, Gorelick FS, Hegyi P, Rakonczay Z Jr, Gukovsky I, Gukovskaya AS. Mitochondrial Dysfunction, Through Impaired Autophagy, Leads to Endoplasmic Reticulum Stress, Deregulated Lipid Metabolism, and Pancreatitis in Animal Models. Gastroenterology. 2018 Feb;154(3):689-703. doi: 10.1053/j.gastro.2017.10.012. Epub 2017 Oct 23.

  PMID: 29074451 BACKGROUND

• Zhang X, Cui Y, Fang L, Li F. Chronic high-fat diets induce oxide injuries and fibrogenesis of pancreatic cells in rats. Pancreas. 2008 Oct;37(3):e31-8. doi: 10.1097/MPA.0b013e3181744b50.

  PMID: 18815536 BACKGROUND

• Czako L, Szabolcs A, Vajda A, Csati S, Venglovecz V, Rakonczay Z Jr, Hegyi P, Tiszlavicz L, Csont T, Posa A, Berko A, Varga C, Varga Ilona S, Boros I, Lonovics J. Hyperlipidemia induced by a cholesterol-rich diet aggravates necrotizing pancreatitis in rats. Eur J Pharmacol. 2007 Oct 15;572(1):74-81. doi: 10.1016/j.ejphar.2007.05.064. Epub 2007 Jun 13.

  PMID: 17628538 BACKGROUND

• Nordback I, Pelli H, Lappalainen-Lehto R, Jarvinen S, Raty S, Sand J. The recurrence of acute alcohol-associated pancreatitis can be reduced: a randomized controlled trial. Gastroenterology. 2009 Mar;136(3):848-55. doi: 10.1053/j.gastro.2008.11.044. Epub 2008 Nov 27.

  PMID: 19162029 BACKGROUND

• Bueno NB, de Melo IS, de Oliveira SL, da Rocha Ataide T. Very-low-carbohydrate ketogenic diet v. low-fat diet for long-term weight loss: a meta-analysis of randomised controlled trials. Br J Nutr. 2013 Oct;110(7):1178-87. doi: 10.1017/S0007114513000548. Epub 2013 May 7.

  PMID: 23651522 BACKGROUND

• Mansoor N, Vinknes KJ, Veierod MB, Retterstol K. Effects of low-carbohydrate diets v. low-fat diets on body weight and cardiovascular risk factors: a meta-analysis of randomised controlled trials. Br J Nutr. 2016 Feb 14;115(3):466-79. doi: 10.1017/S0007114515004699.

  PMID: 26768850 BACKGROUND

• Lu M, Wan Y, Yang B, Huggins CE, Li D. Effects of low-fat compared with high-fat diet on cardiometabolic indicators in people with overweight and obesity without overt metabolic disturbance: a systematic review and meta-analysis of randomised controlled trials. Br J Nutr. 2018 Jan;119(1):96-108. doi: 10.1017/S0007114517002902. Epub 2017 Dec 7.

  PMID: 29212558 BACKGROUND

• Nordmann AJ, Nordmann A, Briel M, Keller U, Yancy WS Jr, Brehm BJ, Bucher HC. Effects of low-carbohydrate vs low-fat diets on weight loss and cardiovascular risk factors: a meta-analysis of randomized controlled trials. Arch Intern Med. 2006 Feb 13;166(3):285-93. doi: 10.1001/archinte.166.3.285.

  PMID: 16476868 BACKGROUND

• Marta K, Szabo AN, Pecsi D, Varju P, Bajor J, Godi S, Sarlos P, Miko A, Szemes K, Papp M, Tornai T, Vincze A, Marton Z, Vincze PA, Lanko E, Szentesi A, Molnar T, Hagendorn R, Faluhelyi N, Battyani I, Kelemen D, Papp R, Miseta A, Verzar Z, Lerch MM, Neoptolemos JP, Sahin-Toth M, Petersen OH, Hegyi P; Hungarian Pancreatic Study Group. High versus low energy administration in the early phase of acute pancreatitis (GOULASH trial): protocol of a multicentre randomised double-blind clinical trial. BMJ Open. 2017 Sep 14;7(9):e015874. doi: 10.1136/bmjopen-2017-015874.

  PMID: 28912191 BACKGROUND

• Parniczky A, Mosztbacher D, Zsoldos F, Toth A, Lasztity N, Hegyi P; Hungarian Pancreatic Study Group and the International Association of Pancreatology. Analysis of Pediatric Pancreatitis (APPLE Trial): Pre-Study Protocol of a Multinational Prospective Clinical Trial. Digestion. 2016;93(2):105-10. doi: 10.1159/000441353. Epub 2015 Nov 26.

  PMID: 26613586 BACKGROUND

• Miko A, Eross B, Sarlos P, Hegyi P Jr, Marta K, Pecsi D, Vincze A, Bodis B, Nemes O, Faluhelyi N, Farkas O, Papp R, Kelemen D, Szentesi A, Hegyi E, Papp M, Czako L, Izbeki F, Gajdan L, Novak J, Sahin-Toth M, Lerch MM, Neoptolemos J, Petersen OH, Hegyi P. Observational longitudinal multicentre investigation of acute pancreatitis (GOULASH PLUS): follow-up of the GOULASH study, protocol. BMJ Open. 2019 Sep 3;9(8):e025500. doi: 10.1136/bmjopen-2018-025500.

  PMID: 31481363 BACKGROUND

• Zadori N, Gede N, Antal J, Szentesi A, Alizadeh H, Vincze A, Izbeki F, Papp M, Czako L, Varga M, de-Madaria E, Petersen OH, Singh VP, Mayerle J, Faluhelyi N, Miseta A, Reiber I, Hegyi P. EarLy Elimination of Fatty Acids iN hypertriglyceridemia-induced acuTe pancreatitis (ELEFANT trial): Protocol of an open-label, multicenter, adaptive randomized clinical trial. Pancreatology. 2020 Apr;20(3):369-376. doi: 10.1016/j.pan.2019.12.018. Epub 2019 Dec 30.

  PMID: 31959416 BACKGROUND

• Parniczky A, Abu-El-Haija M, Husain S, Lowe M, Oracz G, Sahin-Toth M, Szabo FK, Uc A, Wilschanski M, Witt H, Czako L, Grammatikopoulos T, Rasmussen IC, Sutton R, Hegyi P. EPC/HPSG evidence-based guidelines for the management of pediatric pancreatitis. Pancreatology. 2018 Mar;18(2):146-160. doi: 10.1016/j.pan.2018.01.001. Epub 2018 Jan 4.

  PMID: 29398347 BACKGROUND

• Hritz I, Czako L, Dubravcsik Z, Farkas G, Kelemen D, Lasztity N, Morvay Z, Olah A, Pap A, Parniczky A, Sahin-Toth M, Szentkereszti Z, Szmola R, Szucs A, Takacs T, Tiszlavicz L, Hegyi P; Magyar Hasnyalmirigy Munkacsoport, Hungarian Pancreatic Study Group. [Acute pancreatitis. Evidence-based practice guidelines, prepared by the Hungarian Pancreatic Study Group]. Orv Hetil. 2015 Feb 15;156(7):244-61. doi: 10.1556/OH.2015.30059. Hungarian.

  PMID: 25661970 BACKGROUND

Related Links

• W.H.O. Healthy diet 2018 \[Available from: https://www.who.int/news-room/fact-sheets/detail/healthy-diet.

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Officials

• Péter Hegyi, MD, PhD, DSc

  Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary

  STUDY CHAIR

Central Study Contacts

Péter Hegyi, MD, PhD, DSc

CONTACT

+36703751031; hegyi2009@gmail.com

Félix Márk Juhász, MD

CONTACT

+36203733370; flixjuhsz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Doctors caring for the participants and assessors of all other outcomes (laboratory parameters, BMI, blood pressure, adverse events) as well as statisticians handling the data will be blinded to the participants' allocated group. Outcome assessors will be not avare of the allocated interventions.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs

Study Record Dates

• First Submitted: February 15, 2021
• First Posted: February 21, 2021
• Study Start: May 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: November 15, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)