Clinical trial NCT04761523: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Acute Pancreatitis
Keywords: acute pancreatitis
dietary fat
low-fat diet
pancreatitis recurrence
Lead sponsor: University of Pecs
Sponsor class: OTHER
First posted: 2021-02-21
Enrollment: 384
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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.

Primary outcomes:
measure: Occurrence of recurrent acute pancreatitis and/or all-cause mortality
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary outcomes:
measure: Proportion of pancreas specific mortality
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Proportion of cardiosvascular cause mortality
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Proportion of newly diagnosed chronic pancreatitis patients
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Changes in BMI
timeFrame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
measure: Serum total cholesterol
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Change in serum total cholesterol
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Serum triglyceride
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Change in serum triglyceride
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Serum high density liporpotein(HDL)-cholesterol
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Change in serum high density liporpotein(HDL)-cholesterol
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Serum low density liporpotein(LDL)-cholesterol
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Change in serum low density liporpotein(LDL)-cholesterol
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Systolic blood pressure value
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Change in systolic blood pressure
timeFrame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
measure: Diastolic blood pressure
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Change in siastolic blood pressure
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Adherence to dietary recommendations as determined by the result of the food frequency questionnaire
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Adverse effects
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Serum albumin value
timeFrame: Data will be recorded during the 3-6-12-18-24 months followup visits
measure: Change in serum albumin value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Proportion of current smokers
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Muscle strength
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Vitamin A value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Change in vitamin A value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Vitamin D value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Change in vitamin D value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Vitamin E value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Change in vitamin E value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Vitamin K value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Change in vitamin K value
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Change in smoking
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Change in quality of life
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
measure: Change in muscle strength
timeFrame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Other outcomes:
Locations:
city: Budapest
country: Hungary
facility: Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University
Study officials:
affiliation: Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
name: Péter Hegyi, MD, PhD, DSc
role: STUDY_CHAIR
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