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Trial record 2 of 92 for:    Recruiting, Not yet recruiting, Available Studies | "Malabsorption Syndromes"

Enteral Nutrition and Amino Acid Absorption (PEPS)

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ClinicalTrials.gov Identifier: NCT02590120
Recruitment Status : Recruiting
First Posted : October 28, 2015
Last Update Posted : October 20, 2017
Sponsor:
Information provided by (Responsible Party):
Nestlé

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 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
Study Start Date : February 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

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



Primary Outcome Measures :
  1. Amino acid absorption profile [ Time Frame: 48 hours ]
    Area under the curve of amino acid plasma concentration


Secondary Outcome Measures :
  1. Tolerance [ Time Frame: 48 hours ]
    Description and occurence of adverse events

  2. Nutritional status [ Time Frame: 48 hours ]
    Retinol Binding Protein and Transthyretin dosage

  3. Essentials amino acid absorption [ Time Frame: 48 hours ]
    Area under the curve of plasma concentration

  4. Insulinemia evolution [ Time Frame: 48 hours ]
    Insulinemia dosage

  5. Link between amino acid and insuline [ Time Frame: 48 hours ]
    Correlation coefficient



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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): NCT02590120


Locations
France
CHU de Lille Recruiting
Lille, France, 59037
Contact: Dominique Deplanque    +33320446891    dominique.deplanque@chru-lille.fr   
Principal Investigator: David Seguy         
Sponsors and Collaborators
Nestlé
Investigators
Study Chair: Julien Gautry, MD Nestle Health Science

Responsible Party: Nestlé
ClinicalTrials.gov Identifier: NCT02590120     History of Changes
Other Study ID Numbers: 12.02.FR.NHS
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: October 20, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases