Enteral Nutrition Product in Mild Acute Pancreatitis

June 21, 2012 updated by: Vegenat, S.A.

Evaluation of Oral Enteral Nutrition Supplement in Patients With Mild Acute Pancreatitis

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28007
        • Recruiting
        • Clinical Nutrition and Dietetic Unit, Hospital Universitario Gregorio Marañón
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • ALIT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vegenat, S.A.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

November 26, 2010

First Submitted That Met QC Criteria

November 26, 2010

First Posted (Estimate)

November 30, 2010

Study Record Updates

Last Update Posted (Estimate)

June 22, 2012

Last Update Submitted That Met QC Criteria

June 21, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ATEM2010
  • Atémpero IDI-20080283 (Other Identifier: VEGENAT, S.A.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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