Ignite Creation Date:
2024-05-06 @ 3:48 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04761523
Status:
RECRUITING
Last Update Posted:
2022-11-15
First Post:
2021-02-15
Brief Title:
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis
Sponsor:
University of Pecs
Organization:
University of Pecs
Study Overview
Official Title:
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis EFFORT Protocol of a Multicentre Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EFFORT
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None