Enteral Nutrition Product in Mild Acute Pancreatitis

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01249963

Enrollment

Registered

2010-11-30

Start date

2011-02-28

Completion date

2013-03-31

Last updated

2012-06-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pancreatitis, Enteral Nutrition

Keywords

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

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

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.

Interventions

DIETARY_SUPPLEMENTT-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.

DIETARY_SUPPLEMENTAlitraQ (Abbott)

AlitraQ is a nutritional product for patients with impaired gastrointestinal function.For oral or tube nutrition. Enriched with glutamine and arginine.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Acceptance, Tolerance and Nutritional Status	1 year	* To compare the acceptance and tolerance of both products. * To compare the nutritional status in both arms.

Secondary

Measure	Time frame	Description
Inflammatory parameters evolution and EN complications	1 year	* To compare the inflammatory parameters evolution in both arms. * To evaluate the enteral nutrition complications.

Countries

Spain

Contacts

Primary ContactCristina Velasco Gimeno, BA

cvelasco.hgugm@salud.madrid.org+34 91 586 71 64

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026