Enteral Nutrition Product in Mild Acute Pancreatitis

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Condition or disease	Intervention/treatment	Phase
Acute Pancreatitis; Enteral Nutrition	Dietary Supplement: T-Diet plus Atémpero; Dietary Supplement: AlitraQ (Abbott)	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	40 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Participant)
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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Contacts

Contact: Cristina Velasco Gimeno, BA	+34 91 586 71 64	cvelasco.hgugm@salud.madrid.org

Locations

Spain
Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón	Recruiting
Madrid, Spain, 28007
Contact: Cristina Velasco Gimeno, BA +34 91 586 71 64 cvelasco.hgugm@salud.madrid.org

Sponsors and Collaborators

Vegenat, S.A.

Investigators

Principal Investigator:	Pilar García-Peris, PhD	Hospital Universitario Gregorio Marañón

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Vegenat, S.A.
ClinicalTrials.gov Identifier:	NCT01249963 History of Changes
Other Study ID Numbers:	ATEM2010; Atémpero IDI-20080283 ( Other Identifier: VEGENAT, S.A. )
First Posted:	November 30, 2010
Last Update Posted:	June 22, 2012
Last Verified:	February 2011

Keywords provided by Vegenat, S.A.:

acute pancreatitis; enteral nutrition; nutritional status; pancreas; T-Diet plus Atémpero

Additional relevant MeSH terms:

Pancreatitis; Pancreatic Diseases; Digestive System Diseases; Phentermine; Central Nervous System Stimulants; Physiological Effects of Drugs; Appetite Depressants	Anti-Obesity Agents; Sympathomimetics; Autonomic Agents; Peripheral Nervous System Agents; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action