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This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Reduced fat arm | Active Comparator | Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins |
|
| Standard healthy diet arm | Active Comparator | Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of pancreas specific mortality | Mortality of a pancreatic cause | Data will be recorded during the 3-6-12-18-24 months followup visits |
| Proportion of cardiosvascular cause mortality | Mortality of a cardiovascular cause. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Péter Hegyi, MD, PhD, DSc | Contact | +36703751031 | hegyi2009@gmail.com | |
| Félix Márk Juhász, MD | Contact | +36203733370 | flixjuhsz@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Péter Hegyi, MD, PhD, DSc | Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University | Recruiting | Budapest | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18206812 | Background | 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. | |
| 26299411 | 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. |
| Label | URL |
|---|---|
| W.H.O. Healthy diet 2018 \[Available from: https://www.who.int/news-room/fact-sheets/detail/healthy-diet. | View source |
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| ID | Term |
|---|---|
| D010195 | Pancreatitis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
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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.
| 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. |
|
| Data will be recorded during the 3-6-12-18-24 months followup visits |
| 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 |
| 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 |
| Serum total cholesterol | Serum total cholesterol absolute value | Data will be recorded during the 3-6-12-18-24 months followup visits |
| 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 |
| Serum triglyceride | Serum triglyceride absolute value | Data will be recorded during the 3-6-12-18-24 months followup visits |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Systolic blood pressure value | Systolic blood pressure absolute value | Data will be recorded during the 3-6-12-18-24 months followup visits |
| 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 |
| Diastolic blood pressure | Diastolic blood pressure absolute value | Data will be recorded during the 3-6-12-18-24 months followup visits |
| 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 |
| 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 |
| Adverse effects | Adverse effects given as rate of events | Data will be recorded during the 3-6-12-18-24 months followup visits |
| Serum albumin value | Serum albumin absolute value | Data will be recorded during the 3-6-12-18-24 months followup visits |
| 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 |
| 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 |
| 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 |
| 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 |
| Vitamin A value | Vitamin A absolute value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits |
| 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 |
| Vitamin D value | Vitamin D absolute value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits |
| 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 |
| Vitamin E value | Vitamin E absolute value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits |
| 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 |
| Vitamin K value | Vitamin K absolute value | Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits |
| 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 |
| 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 |
| 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 |
| 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 |
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