The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

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

Sponsors

Lead Sponsor: University of Pecs

Source University of Pecs
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.

Overall Status Not yet recruiting
Start Date April 1, 2021
Completion Date December 31, 2026
Primary Completion Date December 31, 2024
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Composite endpoint Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary Outcome
Measure Time Frame
Pancreas specific mortality Data will be recorded during the 3-6-12-18-24 months followup visits
Cardiosvascular cause mortality Data will be recorded during the 3-6-12-18-24 months followup visits
Newly diagnosed chronic pancreatitis Data will be recorded during the 3-6-12-18-24 months followup visits
Changes in BMI Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Serum total cholesterol Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum total cholesterol Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum triglyceride Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum triglyceride Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum high density liporpotein(HDL)-cholesterol Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum high density liporpotein(HDL)-cholesterol Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum low density liporpotein(LDL)-cholesterol Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum low density liporpotein(LDL)-cholesterol Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Systolic blood pressure value Data will be recorded during the 3-6-12-18-24 months followup visits
Change in systolic blood pressure Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Diastolic blood pressure Data will be recorded during the 3-6-12-18-24 months followup visits
Change in siastolic blood pressure 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 Data will be recorded during the 3-6-12-18-24 months followup visits
Adverse effects Data will be recorded during the 3-6-12-18-24 months followup visits
Serum albumin value Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum albumin value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Current smoking 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 Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Muscle strength Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin A value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin A value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin D value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin D value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin E value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin E value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin K value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin K value Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in smoking Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in quality of life Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in muscle strength Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Enrollment 384
Condition
Intervention

Intervention Type: Behavioral

Intervention Name: Dietary intervention: reduced fat diet

Description: Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.

Arm Group Label: Reduced fat arm

Intervention Type: Behavioral

Intervention Name: Dietary intervention: standard healthy diet

Description: Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.

Arm Group Label: Standard healthy diet arm

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.

Gender: All

Minimum Age: 14 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Péter Hegyi, MD, PhD, DSc Study Chair Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
Overall Contact

Last Name: Péter Hegyi, MD, PhD, DSc

Phone: +36703751031

Email: [email protected]

Verification Date

February 2021

Responsible Party

Type: Principal Investigator

Investigator Affiliation: University of Pecs

Investigator Full Name: Dr Hegyi Péter

Investigator Title: Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Reduced fat arm

Type: Active Comparator

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

Label: Standard healthy diet arm

Type: Active Comparator

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

Acronym EFFORT
Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Double (Care Provider, Outcomes Assessor)

Masking Description: Doctors caring for the participants and assessors of all other outcomes (laboratory parameters, BMI, blood pressure, adverse events) as well as statisticians handling the data will be blinded to the participants' allocated group. Outcome assessors will be not avare of the allocated interventions.

Source: ClinicalTrials.gov