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Enteral Nutrition and Amino Acid Absorption (PEPS)

Primary Purpose

Malabsorption

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Enteral nutrition
Sponsored by
Société des Produits Nestlé (SPN)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Malabsorption

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • CHU de Lille

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Enteral nutrition product : product A

Enteral nutrition product : product B

Arm Description

Administration during 16 hours.

Administration during 16 hours.

Outcomes

Primary Outcome Measures

Amino acid absorption profile
Area under the curve of amino acid plasma concentration

Secondary Outcome Measures

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

Full Information

First Posted
October 27, 2015
Last Updated
April 14, 2022
Sponsor
Société des Produits Nestlé (SPN)
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1. Study Identification

Unique Protocol Identification Number
NCT02590120
Brief Title
Enteral Nutrition and Amino Acid Absorption
Acronym
PEPS
Official Title
Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (Actual)
Primary Completion Date
December 2021 (Actual)
Study Completion Date
December 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Société des Produits Nestlé (SPN)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malabsorption

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Enteral nutrition product : product A
Arm Type
Active Comparator
Arm Description
Administration during 16 hours.
Arm Title
Enteral nutrition product : product B
Arm Type
Active Comparator
Arm Description
Administration during 16 hours.
Intervention Type
Dietary Supplement
Intervention Name(s)
Enteral nutrition
Primary Outcome Measure Information:
Title
Amino acid absorption profile
Description
Area under the curve of amino acid plasma concentration
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Tolerance
Description
Description and occurence of adverse events
Time Frame
48 hours
Title
Nutritional status
Description
Retinol Binding Protein and Transthyretin dosage
Time Frame
48 hours
Title
Essentials amino acid absorption
Description
Area under the curve of plasma concentration
Time Frame
48 hours
Title
Insulinemia evolution
Description
Insulinemia dosage
Time Frame
48 hours
Title
Link between amino acid and insuline
Description
Correlation coefficient
Time Frame
48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien Gautry, MD
Organizational Affiliation
Nestle Health Science
Official's Role
Study Chair
Facility Information:
Facility Name
CHU de Lille
City
Lille
ZIP/Postal Code
59037
Country
France

12. IPD Sharing Statement

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Enteral Nutrition and Amino Acid Absorption

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