Enteral Nutrition Product in Mild Acute Pancreatitis
Recruitment status was: Recruiting
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
|Acute Pancreatitis Enteral Nutrition||Dietary Supplement: T-Diet plus Atémpero Dietary Supplement: AlitraQ (Abbott)|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Supportive Care
|Official Title:||Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis|
- 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.
- Inflammatory parameters evolution and EN complications [ Time Frame: 1 year ]
- To compare the inflammatory parameters evolution in both arms.
- To evaluate the enteral nutrition complications.
|Study Start Date:||February 2011|
|Estimated Study Completion Date:||March 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Experimental: Experimental Group
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
T-Diet plus Atémpero is a complete normocaloric and normoproteic enteral nutrition product for the dietary management of patients with mild acute pancreatitis.
Other Name: ATEMP
Active Comparator: Control Diet
Patients of this group will receive 2 packets (76 g) per day of AlitraQ (Abbott) product during 28 days.
Dietary Supplement: AlitraQ (Abbott)
AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.
Other Name: ALIT
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249963
|Contact: Cristina Velasco Gimeno, BA||+34 91 586 71 email@example.com|
|Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón||Recruiting|
|Madrid, Spain, 28007|
|Contact: Cristina Velasco Gimeno, BA +34 91 586 71 64 firstname.lastname@example.org|
|Principal Investigator:||Pilar García-Peris, PhD||Hospital Universitario Gregorio Marañón|