PEPS: Enteral Nutrition and Amino Acid Absorption

• Sponsor: Nestlé (Industry)
• Overall Status: Completed
• CT.gov ID: NCT02590120
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Actual Duration (Months): 82
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Malabsorption	Dietary Supplement: Enteral nutrition	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Single (Participant)
• Primary Purpose: Other
• Official Title: Comparaison du Profil d'Absorption Des Acides aminés Entre Une Nutrition entérale Semi-élémentaire et Une Nutrition entérale polymérique
• Actual Study Start Date: Feb 1, 2015
• Actual Primary Completion Date: Dec 1, 2021
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Amino acid absorption profile [48 hours]

   Area under the curve of amino acid plasma concentration

Secondary Outcome Measures

1. Tolerance [48 hours]

   Description and occurence of adverse events

2. Nutritional status [48 hours]

   Retinol Binding Protein and Transthyretin dosage

3. Essentials amino acid absorption [48 hours]

   Area under the curve of plasma concentration

4. Insulinemia evolution [48 hours]

   Insulinemia dosage

5. Link between amino acid and insuline [48 hours]

   Correlation coefficient

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Lille	Lille		France	59037

Sponsors and Collaborators

• Nestlé

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nestlé
• ClinicalTrials.gov Identifier: NCT02590120
• Other Study ID Numbers: 12.02.FR.NHS
• First Posted: Oct 28, 2015
• Last Update Posted: Apr 15, 2022
• Last Verified: Mar 1, 2022

• Additional relevant MeSH terms: Malabsorption Syndromes

Study Results

No Results Posted as of Apr 15, 2022