- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01172301
Leucine-enriched Essential Amino Acid Intake to Optimize Protein Anabolism in Children With Cystic Fibrosis
Malnutrition, including muscle wasting commonly occurs in children with cystic fibrosis (CF), negatively influencing their quality of life and survival. At the time of a diagnosis of CF, severe protein deficits can already be present. It is important to get CF children fed adequately to prevent that their condition becomes worse or that recovery takes longer. Oral supplementation trials showed that gains in lean body mass are difficult to achieve in CF unless specific metabolic abnormalities are targeted. However, the specific needs for certain food components are not clear yet in children that are ill. Therefore, more information is necessary on the need for protein and certain amino acids in children with CF. Previous studies support the concept of essential amino acids (EAA) as an anabolic stimulus in the young and elderly and in insulin resistant states. Until yet no information is present on the anabolic effects of EAA in CF.
It is therefore our hypothesis that a high-leucine essential amino acids mixture specifically designed to stimulate protein anabolism will target the metabolic alterations of pediatric subjects with CF. In the present proposal, the acute metabolic effects of this high leucine essential amino acids mixture will be examined in pediatric subjects with CF and compared to that of a regular balanced total mixture of essential and non-essential amino acids. The principal endpoints will be the extent of stimulation of whole body protein synthesis as this is the principal mechanism by which either amino acid or protein intake causes muscle anabolism, and the reduction in endogenous protein breakdown. Both endpoints will be assessed by isotope methodology which is thought to be the reference method.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Arkansas
-
Little Rock, Arkansas, United States, 72205
- University of Arkansas for Medical Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects who already have a diagnosis of CF based on universal diagnostic criteria.
- Age 14 to 21 years at the time of enrollment
- Under routine medical control at the CF center of ACH
- Admitted to the ACH for treatment of pulmonary exacerbation of CF disease.
- Improvement in lung function (FEV1) at the time of enrollment back to baseline values (as determined in the clinically stable pre-hospital period)
- Central or peripheral venous line in place
- No planned major changes or interventions in the treatment and care of the pediatric subject on Day -2 and -1 before discharge from the hospital.
Exclusion Criteria:
- Established diagnosis of Diabetes Mellitus
- Presence of fever within the last 3 days
- Unstable metabolic diseases including liver (cirrhosis) or renal disease
- Chronic respiratory failure with cor pulmonale
- Use of long-term oral corticosteroids or short course of oral corticosteroids in the preceding month before enrollment
- Any other condition according to the principle investigator or study physician would interfere with collecting study samples
- Failure to give assent / informed consent
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Oral EAA vs total AA supplement
|
7 g as bolus
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Net whole body protein synthesis rate
Time Frame: Up to 2 years
|
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
|
Up to 2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Whole body collagen breakdown rate
Time Frame: Up to 2 years
|
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
|
Up to 2 years
|
Urea turnover rate
Time Frame: Up to 2 years
|
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
|
Up to 2 years
|
Arginine turnover rate
Time Frame: Up to 2 years
|
Measured in postabsorptive state
|
Up to 2 years
|
Liver protein synthesis rate
Time Frame: Up to 2 years
|
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
|
Up to 2 years
|
Resting Energy expenditure
Time Frame: Up to 2 years
|
Measured in postabsorptive state
|
Up to 2 years
|
Insulin kinetics
Time Frame: Up to 2 years
|
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
|
Up to 2 years
|
Amino acid kinetics
Time Frame: Up to 2 years
|
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
|
Up to 2 years
|
Glucose kinetics
Time Frame: Up to 2 years
|
Acute change from postabsorptive state after intake of essential amino acid + LEU vs total amino acid supplement
|
Up to 2 years
|
Fat-free mass
Time Frame: Up to 2 years
|
Characterization of subjects
|
Up to 2 years
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 104738
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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