NCT02590120

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

April 15, 2022

Status Verified

March 1, 2022

Enrollment Period

6.8 years

First QC Date

October 27, 2015

Last Update Submit

April 14, 2022

Conditions

Malabsorption

Outcome Measures

Primary Outcomes (1)

  • Amino acid absorption profile

    Area under the curve of amino acid plasma concentration

    48 hours

Secondary Outcomes (5)

  • Tolerance

    48 hours

  • Nutritional status

    48 hours

  • Essentials amino acid absorption

    48 hours

  • Insulinemia evolution

    48 hours

  • Link between amino acid and insuline

    48 hours

Study Arms (2)

Enteral nutrition product : product A

ACTIVE COMPARATOR

Administration during 16 hours.

Dietary Supplement: Enteral nutrition

Enteral nutrition product : product B

ACTIVE COMPARATOR

Administration during 16 hours.

Dietary Supplement: Enteral nutrition

Interventions

Enteral nutritionDIETARY_SUPPLEMENT
Enteral nutrition product : product AEnteral nutrition product : product B

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Malabsorption Syndromes

Interventions

Enteral Nutrition

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Feeding MethodsTherapeuticsNutritional SupportNutrition Therapy

Study Officials

  • Julien Gautry, MD

    Nestle Health Science

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 28, 2015

Study Start

February 1, 2015

Primary Completion

December 1, 2021

Study Completion

December 1, 2021

Last Updated

April 15, 2022

Record last verified: 2022-03

Locations

FR(1)