Enteral Nutrition Product in Mild Acute Pancreatitis

Not Applicable

• Conditions: Acute Pancreatitis; Enteral Nutrition
• Interventions: Dietary Supplement: T-Diet plus Atémpero; Dietary Supplement: AlitraQ (Abbott)

• Registration Number: NCT01249963
• Lead Sponsor: Vegenat, S.A.

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2010-11-26
• Study First Submitted QC: 2010-11-26
• Study First Posted: 2010-11-30
• Status Verified: 2011-02
• Study Start: 2011-02
• Last Update Submitted: 2012-06-21
• Last Update Posted: 2012-06-22
• Primary Completion: 2012-12
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Group	T-Diet plus Atémpero	Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.
Control Diet	AlitraQ (Abbott)	Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.

Primary Outcome Measures

Name	Time	Method
Acceptance, Tolerance and Nutritional Status	1 year	* To compare the acceptance and tolerance of both products.; * To compare the nutritional status in both arms.

Secondary Outcome Measures

Name	Time	Method
Inflammatory parameters evolution and EN complications	1 year	* To compare the inflammatory parameters evolution in both arms.; * To evaluate the enteral nutrition complications.

Trial Locations

Locations (1)

Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón; 🇪🇸 Madrid, Spain