ClinicalTrials.gov
ClinicalTrials.gov Menu

Enteral Nutrition Product in Mild Acute Pancreatitis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Sponsor:
Information provided by (Responsible Party):
Vegenat, S.A.

Study Description
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

Arms and Interventions
Go to 
Top of Page 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
Go to 
Top of Page 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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249963


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
Go to 
Top of Page 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    Key Record Dates
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