Enteral Nutrition Product in Mild Acute Pancreatitis

Vegenat

Status: Unknown

Conditions: Enteral Nutrition; Acute Pancreatitis

Treatments: Dietary Supplement: T-Diet plus Atémpero; Dietary Supplement: AlitraQ (Abbott)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01249963

ATEM2010

Atémpero IDI-20080283 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental Group

Experimental group

Description:

Patients of this group will receive 400 ml per day of T-Diet plus Atémpero product during 28 days.

Treatment:

Dietary Supplement: T-Diet plus Atémpero

Control Diet

Active Comparator group

Description:

Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.

Treatment:

Dietary Supplement: AlitraQ (Abbott)