Division of Pancreatic Diseases, Heart and Vascular Center, Semmelweis University
Budapest, Hungary
Location status: Recruiting
Location contact
Péter Hegyi, Prof.
CONTACT
NCT Number: NCT04761523
This trial aims to test the effects of two different diets on the recurrence of acute pancreatitis, and acute pancreatitis associated mortality.
Interested in participating?
Request Info14 year and older
All sexes
Interventional
Not applicable
Budapest, Hungary
Location status: Recruiting
Péter Hegyi, Prof.
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 15% fat, 65% carbohydrate, 20% protein content.
Participants will receive a dietary intervention, and will be proposed to adhere to a diet with a 30% fat, 50% carbohydrate, 20% protein content.
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.
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Mortality of a pancreatic cause
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Mortality of a cardiovascular cause.
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Newly diagnosed chronic pancreatitis.
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum total cholesterol absolute value
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum triglyceride absolute value
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Serum triglyceride compared to baseline
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum high density liporpotein(HDL)-cholesterol absolute value
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum low density liporpotein(LDL)-cholesterol absolute value
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Systolic blood pressure absolute value
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Diastolic blood pressure absolute value
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
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
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Adverse effects given as rate of events
Time frame: Data will be recorded during the 3-6-12-18-24 months followup visits
Serum albumin absolute 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Current smoking at each visit
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
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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin A absolute 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin D absolute 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin E absolute 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
Time frame: Data will be recorded at baseline, and during the 3-6-12-18-24 months followup visits
Vitamin K absolute 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
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
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
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
Contact information is provided by the study sponsor or research team.
Félix Márk Juhász, MD
CONTACT
Péter Hegyi, MD, PhD, DSc
CONTACT
University of Pecs
Other
The Effect of Dietary Fat Content on the Recurrence of Pancreatitis (EFFORT): Protocol of a Multicentre Randomized Controlled Trial
Acronym: EFFORT
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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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