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

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ClinicalTrials.gov Identifier: NCT04761523
Recruitment Status : Not yet recruiting
First Posted : February 21, 2021
Last Update Posted : February 21, 2021
Sponsor:
Information provided by (Responsible Party):
Dr Hegyi Péter, 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.

Condition or disease Intervention/treatment Phase
Acute Pancreatitis Behavioral: Dietary intervention: reduced fat diet Behavioral: Dietary intervention: standard healthy diet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 384 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Primary Purpose: Prevention
Official Title: The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
Estimated Study Start Date : April 1, 2021
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Composite endpoint [ 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


Secondary Outcome Measures :
  1. Pancreas specific mortality [ Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits ]
    Mortality of a pancreatic cause

  2. Cardiosvascular cause mortality [ Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits ]
    Mortality of a cardiovascular cause

  3. Newly diagnosed chronic pancreatitis [ Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits ]
    Newly diagnosed chronic pancreatitis

  4. 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

  5. Serum total cholesterol [ Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits ]
    Serum total cholesterol absolute value

  6. 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

  7. Serum triglyceride [ Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits ]
    Serum triglyceride absolute value

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. Diastolic blood pressure [ Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits ]
    Diastolic blood pressure absolute value

  16. 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

  17. 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

  18. 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

  19. Serum albumin value [ Time Frame: Data will be recorded during the 3-6-12-18-24 months followup visits ]
    Serum albumin absolute value

  20. 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

  21. Current smoking [ Time Frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits ]
    Current smoking at each visit

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. 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

  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   14 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04761523


Contacts
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Contact: Péter Hegyi, MD, PhD, DSc +36703751031 hegyi2009@gmail.com
Contact: Félix Márk Juhász, MD +36203733370 flixjuhsz@gmail.com

Sponsors and Collaborators
University of Pecs
Investigators
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Study Chair: Péter Hegyi, MD, PhD, DSc Insitute for Translational Medicine, University of Pécs, Medical School, Pécs, Hungary
Additional Information:
Publications:

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Responsible Party: Dr Hegyi Péter, Principal Investigator, Director of the Centre for Translational Medicine at University of Pécs, University of Pecs
ClinicalTrials.gov Identifier: NCT04761523    
Other Study ID Numbers: 40304-11/2020/EÜIG
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: February 21, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr Hegyi Péter, University of Pecs:
acute pancreatitis
dietary fat
low-fat diet
pancreatitis recurrence
Additional relevant MeSH terms:
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Pancreatitis
Recurrence
Disease Attributes
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases