The EFFect of dietary fat content on the recurrence of pancreaTitis (EFFORT): Protocol of a multicenter randomized controlled trial.
Study Goal
The researchers aimed to determine whether reducing dietary fat content could prevent acute pancreatitis recurrence in idiopathic cases.
Results Summary
The study is designed to compare the effects of a reduced-fat diet (15% fat) versus a standard healthy diet (30% fat) on pancreatitis recurrence, mortality, serum lipids, and weight loss, but results are not yet available as the study is ongoing.
Population
Patients with at least 2 episodes of acute pancreatitis in the preceding 2 years, with the last episode being idiopathic.
Effective Dosage
Reduced-fat diet (15% fat, 65% carbohydrate, 20% protein) vs. standard healthy diet (30% fat, 50% carbohydrate, 20% protein).
Duration
2 years
Interactions
None mentioned
| Intervention | Direction | Endpoint | Population | Dosage | Impact | Claim # |
|---|---|---|---|---|---|---|
low-fat diet | decrease | acute recurrent pancreatitis | patients with idiopathic acute recurrent pancreatitis | - | often recommended | #1 |
dietary fat reduction | decrease | acute pancreatitis recurrence | participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic | - | test effect | #2 |
reduced fat diet | decrease | acute pancreatitis recurrence | participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic | - | will determine the effect | #3 |
reduced fat diet | decrease | mortality | participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic | - | will determine the effect | #4 |
reduced fat diet | decrease | serum lipids | participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic | - | will determine the effect | #5 |
reduced fat diet | increase | weight loss | participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic | - | will determine the effect | #6 |
BACKGROUND: Around 20% of patients with acute pancreatitis (AP) will develop acute recurrent pancreatitis (ARP) and 10% will progress to chronic pancreatitis. While interventions to avoid recurrences exist for the two most common causes - abstinence for alcoholic and cholecystectomy for biliary pancreatitis - the are no known preventive measures in idiopathic ARP. Though it is not included in any of the guidelines, a low-fat diet is often recommended. Our aim is to test dietary fat reduction's effect on AP recurrence in a randomized controlled setting, in order to provide high-quality evidence for the validity of such an intervention. METHODS, DESIGN: Participants with at least 2 episodes of AP in the preceding 2 years of which the last episode was idiopathic will be randomized to one of two diets with different fat contents: a 'reduced fat diet' (15% fat, 65% carbohydrate, 20% protein) and a 'standard healthy diet' (30% fat, 50% carbohydrate, 20% protein; based on WHO recommendations). Participants will be followed-up for 2 years (visits will be scheduled for months 3, 6, 12, 18 and 24) during which they will receive a repeated session of nutritional guidance, complete food frequency questionnaires and data on relapse, mortality, BMI, cardiovascular parameters and serum lipid values will be collected. DISCUSSION: This study will determine the effect of modifying the dietary fat content on AP recurrence, mortality, serum lipids and weight loss in idiopathic cases.