Back to resultsThe Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT)
Primary Purpose
Acute Pancreatitis
Status
Recruiting
Phase
Not Applicable
Locations
Hungary
Study Type
Interventional
Intervention
Dietary intervention: reduced fat diet
Dietary intervention: standard healthy diet
Sponsored by
About this trial
This is an interventional prevention trial for Acute Pancreatitis focused on measuring acute pancreatitis, dietary fat, low-fat diet, pancreatitis recurrence
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.
Sites / Locations
- Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Reduced fat arm
Standard healthy diet arm
Arm Description
Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins
Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins.
Outcomes
Primary Outcome Measures
Occurrence of recurrent acute pancreatitis and/or all-cause mortality
The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality.
Secondary Outcome Measures
Proportion of pancreas specific mortality
Mortality of a pancreatic cause
Proportion of cardiosvascular cause mortality
Mortality of a cardiovascular cause.
Proportion of newly diagnosed chronic pancreatitis patients
Newly diagnosed chronic pancreatitis.
Changes in BMI
Changes in BMI compared to baseline both in total and percentage
Serum total cholesterol
Serum total cholesterol absolute value
Change in serum total cholesterol
Serum total cholesterol compared to baseline
Serum triglyceride
Serum triglyceride absolute value
Change in serum triglyceride
Serum triglyceride compared to baseline
Serum high density liporpotein(HDL)-cholesterol
Serum high density liporpotein(HDL)-cholesterol absolute value
Change in serum high density liporpotein(HDL)-cholesterol
Serum high density liporpotein(HDL)-cholesterol compared to baseline
Serum low density liporpotein(LDL)-cholesterol
Serum low density liporpotein(LDL)-cholesterol absolute value
Change in serum low density liporpotein(LDL)-cholesterol
Serum low density liporpotein(LDL)-cholesterol compared to baseline
Systolic blood pressure value
Systolic blood pressure absolute value
Change in systolic blood pressure
Systolic blood pressure compared to baseline
Diastolic blood pressure
Diastolic blood pressure absolute value
Change in siastolic blood pressure
Diastolic blood pressure compared to baseline
Adherence to dietary recommendations as determined by the result of the food frequency questionnaire
Adherence to dietary recommendations as determined by the result of the food frequency questionnaire
Adverse effects
Adverse effects given as rate of events
Serum albumin value
Serum albumin absolute value
Change in serum albumin value
Serum albumin value compared to baseline
Proportion of current smokers
Current smoking at each visit
Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Quality of life assessed by the EQ-5D-5L questionnaire
Muscle strength
Muscle strength using a handgrip dynamometer
Vitamin A value
Vitamin A absolute value
Change in vitamin A value
Change in vitamin A value compared to baseline
Vitamin D value
Vitamin D absolute value
Change in vitamin D value
Change in vitamin D value compared to baseline
Vitamin E value
Vitamin E absolute value
Change in vitamin E value
Change in vitamin E value compared to baseline
Vitamin K value
Vitamin K absolute value
Change in vitamin K value
Change in vitamin K value compared to baseline
Change in smoking
Change in smoking compared to baseline
Change in quality of life
Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline
Change in muscle strength
Change in muscle strength using a handgrip dynamometer compared to baseline
Full Information
NCT ID
NCT04761523
First Posted
February 15, 2021
Last Updated
November 14, 2022
Sponsor
University of Pecs
1. Study Identification
Unique Protocol Identification Number
NCT04761523
Brief Title
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis
Acronym
EFFORT
Official Title
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pecs
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pancreatitis
Keywords
acute pancreatitis, dietary fat, low-fat diet, pancreatitis recurrence
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderOutcomes 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.
Allocation
Randomized
Enrollment
384 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Reduced fat arm
Arm Type
Active Comparator
Arm Description
Daily calorie intake will be composed of 15% fat, 65% carbohydrates, 20% proteins
Arm Title
Standard healthy diet arm
Arm Type
Active Comparator
Arm Description
Daily calorie intake will be composed of 30% fat, 50% carbohydrates and 20% proteins.
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention: reduced fat diet
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Dietary intervention: standard healthy diet
Intervention 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.
Primary Outcome Measure Information:
Title
Occurrence of recurrent acute pancreatitis and/or all-cause mortality
Description
The recurrence of acute pancreatitis (given as a rate of event) AND/OR all-cause mortality.
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Secondary Outcome Measure Information:
Title
Proportion of pancreas specific mortality
Description
Mortality of a pancreatic cause
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Proportion of cardiosvascular cause mortality
Description
Mortality of a cardiovascular cause.
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Proportion of newly diagnosed chronic pancreatitis patients
Description
Newly diagnosed chronic pancreatitis.
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Changes in BMI
Description
Changes in BMI compared to baseline both in total and percentage
Time Frame
Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Title
Serum total cholesterol
Description
Serum total cholesterol absolute value
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Change in serum total cholesterol
Description
Serum total cholesterol compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Serum triglyceride
Description
Serum triglyceride absolute value
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Change in serum triglyceride
Description
Serum triglyceride compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Serum high density liporpotein(HDL)-cholesterol
Description
Serum high density liporpotein(HDL)-cholesterol absolute value
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Change in serum high density liporpotein(HDL)-cholesterol
Description
Serum high density liporpotein(HDL)-cholesterol compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Serum low density liporpotein(LDL)-cholesterol
Description
Serum low density liporpotein(LDL)-cholesterol absolute value
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Change in serum low density liporpotein(LDL)-cholesterol
Description
Serum low density liporpotein(LDL)-cholesterol compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Systolic blood pressure value
Description
Systolic blood pressure absolute value
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Change in systolic blood pressure
Description
Systolic blood pressure compared to baseline
Time Frame
Data will be recorded az baseline, and during the 3-6-12-18-24 months followup visits
Title
Diastolic blood pressure
Description
Diastolic blood pressure absolute value
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Change in siastolic blood pressure
Description
Diastolic blood pressure compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Adherence to dietary recommendations as determined by the result of the food frequency questionnaire
Description
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
Title
Adverse effects
Description
Adverse effects given as rate of events
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Serum albumin value
Description
Serum albumin absolute value
Time Frame
Data will be recorded during the 3-6-12-18-24 months followup visits
Title
Change in serum albumin value
Description
Serum albumin value compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Proportion of current smokers
Description
Current smoking at each visit
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Quality of life questionnaire on mobility, self-care, usual activities, pain/discomfort and anxiety/depression
Description
Quality of life assessed by the EQ-5D-5L questionnaire
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Muscle strength
Description
Muscle strength using a handgrip dynamometer
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Vitamin A value
Description
Vitamin A absolute value
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Change in vitamin A value
Description
Change in vitamin A value compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Vitamin D value
Description
Vitamin D absolute value
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Change in vitamin D value
Description
Change in vitamin D value compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Vitamin E value
Description
Vitamin E absolute value
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Change in vitamin E value
Description
Change in vitamin E value compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Vitamin K value
Description
Vitamin K absolute value
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Change in vitamin K value
Description
Change in vitamin K value compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Change in smoking
Description
Change in smoking compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Change in quality of life
Description
Change in quality of life assessed by the EQ-5D-5L questionnaire compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Title
Change in muscle strength
Description
Change in muscle strength using a handgrip dynamometer compared to baseline
Time Frame
Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Péter Hegyi, MD, PhD, DSc
Phone
+36703751031
Email
hegyi2009@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Félix Márk Juhász, MD
Phone
+36203733370
Email
flixjuhsz@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Péter Hegyi, MD, PhD, DSc
Organizational Affiliation
Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
Official's Role
Study Chair
Facility Information:
Facility Name
Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University
City
Budapest
Country
Hungary
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Péter Hegyi, Prof.
12. IPD Sharing Statement
Plan to Share IPD
No
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Links:
URL
https://www.who.int/news-room/fact-sheets/detail/healthy-diet
Description
W.H.O. Healthy diet 2018 [Available from: https://www.who.int/news-room/fact-sheets/detail/healthy-diet.
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The Effect of Dietary Fat Content on the Recurrence of Pancreatitis
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