Enteral Nutrition and Amino Acid Absorption (PEPS)

April 14, 2022 updated by: Nestlé

Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique

The purpose of this study is to evaluate amino acid absorption with two different type of proteins.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

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

  • France
      • Lille, France, 59037
        • CHU de Lille

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:

  • Patient with gastrointestinal disorder : citrulline plasma concentration < 20 µmol/L and/or xylose plasma concentration < 1,7 mmol/L
  • Patient under enteral nutrition at home
  • Patient already receiving 1 L by day

Exclusion Criteria:

  • Obese patient BMI > 30
  • Diabetes
  • Renal or liver failure
  • Glucocorticoids treatment

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Enteral nutrition product : product A
Administration during 16 hours.
Dietary supplement: Enteral nutrition
Active Comparator: Enteral nutrition product : product B
Administration during 16 hours.
Dietary supplement: Enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Amino acid absorption profile
Time Frame: 48 hours
Area under the curve of amino acid plasma concentration
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tolerance
Time Frame: 48 hours
Description and occurence of adverse events
48 hours
Nutritional status
Time Frame: 48 hours
Retinol Binding Protein and Transthyretin dosage
48 hours
Essentials amino acid absorption
Time Frame: 48 hours
Area under the curve of plasma concentration
48 hours
Insulinemia evolution
Time Frame: 48 hours
Insulinemia dosage
48 hours
Link between amino acid and insuline
Time Frame: 48 hours
Correlation coefficient
48 hours

Collaborators and Investigators

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

Sponsor

Nestlé

Investigators

  • Study Chair: Julien Gautry, MD, Nestle Health Science

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 (Actual)

February 1, 2015

Primary Completion (Actual)

December 1, 2021

Study Completion (Actual)

December 1, 2021

Study Registration Dates

First Submitted

October 27, 2015

First Submitted That Met QC Criteria

October 27, 2015

First Posted (Estimate)

October 28, 2015

Study Record Updates

Last Update Posted (Actual)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12.02.FR.NHS

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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