The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT)

University of Pecs

Status: Enrolling

Conditions: Acute Pancreatitis

Treatments: Behavioral: Dietary intervention: standard healthy diet; Behavioral: Dietary intervention: reduced fat diet

Study type: Interventional

Funder types: Other

Identifiers

NCT04761523

40304-11/2020/EÜIG

Details and patient eligibility

About

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

Full 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.

Enrollment: 384 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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384 participants in 2 patient groups

Reduced fat arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Dietary intervention: reduced fat diet

Standard healthy diet arm

Active Comparator group

Description:

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

Treatment:

Behavioral: Dietary intervention: standard healthy diet