Enteral Nutrition Product in Mild Acute Pancreatitis

Study Overview
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Brief Summary
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The aim of the study is to evaluate the beneficial effects of the administration of enteral nutrition product with milk proteins, monounsaturated fatty acids and low dextrose equivalent maltodextrin and enriched in eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA) and medium chain triglycerides (MCT) in patients with mild acute pancreatitis. All this against other specific product. The main objectives of this project are: Comparing the tolerance of both preparations. Comparing the evolution of nutritional status in both groups. Comparing the evolution of inflammatory parameters in both groups

Detailed Description
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Oral administration of an oligomeric formula with milk proteins, mainly whey protein partially hydrolysate, monounsaturated fatty acids (AGM) and low dextrose equivalent maltodextrin and enriched in polyunsaturated fatty acids (PUFA) of omega-3 series, EPA and DHA, and MCT designed for nutritional support of patients with compromised intestinal function, to maintain or improve nutritional status and reduce the inflammatory response in undernourished patients with mild acute pancreatitis, compared with oligomeric enteral nutrition product, low in fat and rich in glutamine.

Official Title
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Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis

Conditions
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Acute Pancreatitis, Enteral Nutrition

Intervention / Treatment
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* Dietary Supplement: T-Diet plus Atémpero
* Dietary Supplement: AlitraQ (Abbott)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients over 18 with Mild Acute Pancreatitis. Exclusion Criteria: Patients with Several Acute Pancreatitis Patients with life expectancy less than 48 hours. Renal (creatinin > 2,5 mg/dl) or kidney failure (GOT/GPT>2 from laboratory normal value) Patients with diabetes mellitus prior to acute pancreatitis. To take part in another study. Pregnant patients Informed consent absence.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days. | Dietary Supplement: T-Diet plus Atémpero<br>* T-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.<br>* Other names: ATEMP;|
| Active Comparator: Control Diet<br>Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days. | Dietary Supplement: AlitraQ (Abbott)<br>* AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.<br>* Other names: ALIT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptance, Tolerance and Nutritional Status | To compare the acceptance and tolerance of both products. To compare the nutritional status in both arms. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory parameters evolution and EN complications | To compare the inflammatory parameters evolution in both arms. To evaluate the enteral nutrition complications. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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acute pancreatitis, enteral nutrition, nutritional status, pancreas, T-Diet plus Atémpero