Health TrialsbyHealthPanel

The Effect of Dietary Fat Content on the Recurrence of Pancreatitis

ConditionAcute Pancreatitis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age14+
SponsorUniversity of Pecs

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

384 Participants
are divided into 2 treatment groups
Group A: Reduced fat armActive comparator 1 intervention
Group B: Standard healthy diet armActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Data will be recorded during the 3-6-12-18-24 months followup visits

Secondary outcomes

1

Proportion of pancreas specific mortality

Mortality of a pancreatic cause

Time frame
Data will be recorded during the 3-6-12-18-24 months followup visits
2

Proportion of cardiosvascular cause mortality

Mortality of a cardiovascular cause.

Time frame
Data will be recorded during the 3-6-12-18-24 months followup visits
3

Proportion of newly diagnosed chronic pancreatitis patients

Newly diagnosed chronic pancreatitis.

Time frame
Data will be recorded during the 3-6-12-18-24 months followup visits
4

Changes in BMI

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pecs

Lead sponsor

Source ClinicalTrials.gov
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