Enteral Nutrition Product in Mild Acute Pancreatitis
|ClinicalTrials.gov Identifier: NCT01249963|
Recruitment Status : Unknown
Verified February 2011 by Vegenat, S.A..
Recruitment status was: Recruiting
First Posted : November 30, 2010
Last Update Posted : June 22, 2012
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
|Condition or disease||Intervention/treatment||Phase|
|Acute Pancreatitis Enteral Nutrition||Dietary Supplement: T-Diet plus Atémpero Dietary Supplement: AlitraQ (Abbott)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||March 2013|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|