The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Acute Pancreatitis

Intervention / Treatment
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* Behavioral: Dietary intervention: reduced fat diet
* Behavioral: Dietary intervention: standard healthy diet


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Reduced fat arm<br>Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins | Behavioral: Dietary intervention: reduced fat diet<br>* Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.<br>|
| Active Comparator: Standard healthy diet arm<br>Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins. | Behavioral: Dietary intervention: standard healthy diet<br>* Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pancreatitis, dietary fat, low-fat diet, pancreatitis recurrence