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NCT Number: NCT04761523

The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

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

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Key information

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University

Budapest, Hungary

Location status: Recruiting

Location contact

Péter Hegyi, Prof.

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dietary intervention: reduced fat diet

Behavioral

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

Dietary intervention: standard healthy diet

Behavioral

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 outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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.

  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. 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

  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

Study contacts

Contact information is provided by the study sponsor or research team.

Félix Márk Juhász, MD

CONTACT

[email protected]

+36203733370

Péter Hegyi, MD, PhD, DSc

CONTACT

[email protected]

+36703751031

Sponsors and collaborators

Lead sponsor

University of Pecs

Other

Registry information

Official study title

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

Acronym: EFFORT

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Feb 21, 2021
Registry last updated
Nov 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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