Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Acute Pancreatitis
- Sponsor
- Vegenat, S.A.
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Acceptance, Tolerance and Nutritional Status
- Last Updated
- 13 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Acceptance, Tolerance and Nutritional Status
Time Frame: 1 year
* To compare the acceptance and tolerance of both products. * To compare the nutritional status in both arms.
Secondary Outcomes
- Inflammatory parameters evolution and EN complications(1 year)