The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

Acute Pancreatitis Clinical Trial

— EFFORT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04761523
• Other study ID #: 40304-11/2020/EÜIG
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: November 2022
• Source: University of Pecs
• Contact: Péter Hegyi, MD, PhD, DSc
• Phone: +36703751031
• Email: hegyi2009[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 384
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis
• Recurrence

Intervention

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.
• 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.

Locations

Country	Name	City	State
Hungary	Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
University of Pecs

Country where clinical trial is conducted

Hungary, 

References & Publications (26)

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Czakó L, Szabolcs A, Vajda A, Csáti S, Venglovecz V, Rakonczay Z Jr, Hegyi P, Tiszlavicz L, Csont T, Pósa A, Berkó 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. Epub 2007 Jun 13. — View Citation

Hritz I, Czakó L, Dubravcsik Z, Farkas G, Kelemen D, Lásztity N, Morvay Z, Oláh A, Pap Á, Párniczky A, Sahin-Tóth M, Szentkereszti Z, Szmola R, Szücs Á, Takács T, Tiszlavicz L, Hegyi P; Magyar Hasnyálmirigy 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. Review. Hungarian. — View Citation

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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. Review. — View Citation

Mansoor N, Vinknes KJ, Veierød MB, Retterstøl 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. — View Citation

Márta K, Szabó AN, Pécsi D, Varjú P, Bajor J, Gódi S, Sarlós P, Mikó A, Szemes K, Papp M, Tornai T, Vincze Á, Márton Z, Vincze PA, Lankó E, Szentesi A, Molnár T, Hágendorn R, Faluhelyi N, Battyáni I, Kelemen D, Papp R, Miseta A, Verzár Z, Lerch MM, Neoptolemos JP, Sahin-Tóth 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. — View Citation

Mikó A, Eross B, Sarlós P, Hegyi P Jr, Márta K, Pécsi D, Vincze Á, Bódis B, Nemes O, Faluhelyi N, Farkas O, Papp R, Kelemen D, Szentesi A, Hegyi E, Papp M, Czakó L, Izbéki F, Gajdán L, Novák J, Sahin-Tóth 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. — View Citation

Nordback I, Pelli H, Lappalainen-Lehto R, Järvinen S, Räty 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. — View Citation

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. Review. Erratum in: Arch Intern Med. 2006 Apr 24;166(8):932. — View Citation

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. — View Citation

Párniczky A, Abu-El-Haija M, Husain S, Lowe M, Oracz G, Sahin-Tóth M, Szabó FK, Uc A, Wilschanski M, Witt H, Czakó 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. Review. — View Citation

Párniczky A, Mosztbacher D, Zsoldos F, Tóth A, Lásztity 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. — View Citation

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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. — View Citation

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. — View Citation

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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. Erratum in: Am J Gastroenterol. 2014 Feb;109(2):302. — View Citation

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. Review. — View Citation

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. — View Citation

Zádori N, Gede N, Antal J, Szentesi A, Alizadeh H, Vincze Á, Izbéki F, Papp M, Czakó 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. — View Citation

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. — View Citation

* Note: There are 26 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of pancreas specific mortality	Mortality of a pancreatic cause	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Proportion of cardiosvascular cause mortality	Mortality of a cardiovascular cause.	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Proportion of newly diagnosed chronic pancreatitis patients	Newly diagnosed chronic pancreatitis.	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Changes in BMI	Changes in BMI compared to baseline both in total and percentage	Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Serum total cholesterol	Serum total cholesterol absolute value	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Change in serum total cholesterol	Serum total cholesterol compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Serum triglyceride	Serum triglyceride absolute value	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Change in serum triglyceride	Serum triglyceride compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Serum high density liporpotein(HDL)-cholesterol	Serum high density liporpotein(HDL)-cholesterol absolute value	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Change in serum high density liporpotein(HDL)-cholesterol	Serum high density liporpotein(HDL)-cholesterol compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Serum low density liporpotein(LDL)-cholesterol	Serum low density liporpotein(LDL)-cholesterol absolute value	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Change in serum low density liporpotein(LDL)-cholesterol	Serum low density liporpotein(LDL)-cholesterol compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Systolic blood pressure value	Systolic blood pressure absolute value	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Change in systolic blood pressure	Systolic blood pressure compared to baseline	Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Diastolic blood pressure	Diastolic blood pressure absolute value	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Change in siastolic blood pressure	Diastolic blood pressure compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Adherence to dietary recommendations as determined by the result of the food frequency questionnaire	Adherence to dietary recommendations as determined by the result of the food frequency questionnaire	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Adverse effects	Adverse effects given as rate of events	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Serum albumin value	Serum albumin absolute value	Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary	Change in serum albumin value	Serum albumin value compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Proportion of current smokers	Current smoking at each visit	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression	Quality of life assessed by the EQ-5D-5L questionnaire	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Muscle strength	Muscle strength using a handgrip dynamometer	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Vitamin A value	Vitamin A absolute value	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Change in vitamin A value	Change in vitamin A value compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Vitamin D value	Vitamin D absolute value	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Change in vitamin D value	Change in vitamin D value compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Vitamin E value	Vitamin E absolute value	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Change in vitamin E value	Change in vitamin E value compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Vitamin K value	Vitamin K absolute value	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Change in vitamin K value	Change in vitamin K value compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Change in smoking	Change in smoking compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Change in quality of life	Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Secondary	Change in muscle strength	Change in muscle strength using a handgrip dynamometer compared to baseline	Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

External Links

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