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

November 14, 2022 updated by: Dr Hegyi Péter, University of Pecs

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

384

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Hungary
      • Budapest, Hungary
        • Recruiting
        • Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University
        • Contact:
          • Péter Hegyi, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Reduced fat arm
Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins
Behavioral: Dietary intervention: reduced fat diet
Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.
Active Comparator: Standard healthy diet arm
Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins.
Behavioral: Dietary intervention: standard healthy diet
Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Occurrence of recurrent acute pancreatitis and/or all-cause mortality
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality.
Data will be recorded during the 3-6-12-18-24 months followup visits

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of pancreas specific mortality
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Mortality of a pancreatic cause
Data will be recorded during the 3-6-12-18-24 months followup visits
Proportion of cardiosvascular cause mortality
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Mortality of a cardiovascular cause.
Data will be recorded during the 3-6-12-18-24 months followup visits
Proportion of newly diagnosed chronic pancreatitis patients
Time Frame: 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
Time Frame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Changes in BMI compared to baseline both in total and percentage
Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Serum total cholesterol
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum total cholesterol absolute value
Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum total cholesterol
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum total cholesterol compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum triglyceride
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum triglyceride absolute value
Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum triglyceride
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum triglyceride compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum high density liporpotein(HDL)-cholesterol
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum high density liporpotein(HDL)-cholesterol absolute value
Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum high density liporpotein(HDL)-cholesterol
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum high density liporpotein(HDL)-cholesterol compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum low density liporpotein(LDL)-cholesterol
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum low density liporpotein(LDL)-cholesterol absolute value
Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum low density liporpotein(LDL)-cholesterol
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum low density liporpotein(LDL)-cholesterol compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Systolic blood pressure value
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Systolic blood pressure absolute value
Data will be recorded during the 3-6-12-18-24 months followup visits
Change in systolic blood pressure
Time Frame: Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Systolic blood pressure compared to baseline
Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Diastolic blood pressure
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Diastolic blood pressure absolute value
Data will be recorded during the 3-6-12-18-24 months followup visits
Change in siastolic blood pressure
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Diastolic blood pressure compared to baseline
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
Time Frame: Data will be recorded 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
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Adverse effects given as rate of events
Data will be recorded during the 3-6-12-18-24 months followup visits
Serum albumin value
Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum albumin absolute value
Data will be recorded during the 3-6-12-18-24 months followup visits
Change in serum albumin value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum albumin value compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Proportion of current smokers
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Current smoking at each visit
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
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Quality of life assessed by the EQ-5D-5L questionnaire
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Muscle strength
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Muscle strength using a handgrip dynamometer
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin A value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin A absolute value
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin A value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin A value compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin D value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin D absolute value
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin D value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin D value compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin E value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin E absolute value
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin E value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin E value compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin K value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin K absolute value
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin K value
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in vitamin K value compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in smoking
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in smoking compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in quality of life
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in muscle strength
Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Change in muscle strength using a handgrip dynamometer compared to baseline
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pecs

Investigators

  • Study Chair: Péter Hegyi, MD, PhD, DSc, Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2022

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2026

Study Registration Dates

First Submitted

February 15, 2021

First Submitted That Met QC Criteria

February 15, 2021

First Posted (Actual)

February 21, 2021

Study Record Updates

Last Update Posted (Actual)

November 15, 2022

Last Update Submitted That Met QC Criteria

November 14, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 40304-11/2020/EÜIG

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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