- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02499926
Lysine Oxidation in Response to Arginine Supplementation
Determination of Lysine Oxidation in Response to Arginine Supplementation in Adult Men Using in Vivo Stable Isotope Techniques
Study Overview
Status
Intervention / Treatment
Detailed Description
Background:
Protein is made up of building blocks called amino acids. Some amino acids, including Lysine, cannot be made in the body and must be obtained from diet, and these are called essential amino acids.
Pyridoxine dependent deficiency (PDE) is a rare condition caused by the body's inability to properly breakdown lysine. This is due to a missing enzyme, α- aminoadipic semi-aldehyde dehydrogenase (α-AASAD) also known as antiquitin (ATQ), involved in lysine breakdown. When the enzyme is missing and/or not functioning properly, it increases the level of byproducts of lysine breakdown that may result in seizures babies and young children and affect brain development. As with many other similar conditions, a low lysine diet may be helpful for some patients, but can pose a significant burden on the patient and the families.
More recently, animal experiments have shown that the body's ability to absorb lysine from the diet can be altered by adding more of another "competitive" amino acid, in this case, arginine. This is because lysine and arginine share the same transport system in the body.
Therefore, the current study is designed to describe the application of 13C-lysine to explore the changes in lysine breakdown caused by varying (graded) amounts of arginine supplementation in young adult male participants.
Study design:
Two adult male subjects aged 19-50 y will be recruited to participate in 6 graded doses of arginine intakes, in addition to a test diet which will provide the lysine at normal intake of 110mg/kg/d. Lysine intake levels, will be determined based on subject age and body weight and will remain constant for the entire study period. The recommended dietary protein intake (DRI) will be maintained throughout the study.
A thorough pre-study assessment will be performed and all subjects will be screened by questionnaire for chronic diseases, physical activity and dietary habits. Lean body mass or skeletal muscle mass (Bioelectrical impedance Analysis) will be measured. Subjects will be ensured to be free of chronic diseases.
Arginine Test Intakes:
Graded arginine excess intake will start at 50mg/kg/d on study day 1 followed by 100 mg/kg/d on study day 2 till the level reaches 300mg/kg/d on study day 6.
The arginine test intakes will be provided in the form of protein shakes containing a stable isotope, and then oxidation of this isotope will be measured to determine whether arginine that will competitively inhibit lysine uptake.
To measure how the the body responds to the test diet we will collect seven breath samples, two urine samples and one blood sample during each study day.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z4H4
- BC Children;s Hospital Research Institute, University of British Columbia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- You are 19 to 50 years-of-age
- Male
- Classified as normal body weight and BMI (18.5-25 kg/m2)
- Free of any concurrent illness (cold, flu, vomiting etc.)
- Not be claustrophobic (we will place a clear hood, which can easily be removed, over your head for approximately 20 min to measure your energy expenditure).
- Not be enrolled in any other research studies (as this may affect our study results)
Exclusion Criteria:
You are not in good health or have a metabolic, neurological, genetic, or immune disorder, including diabetes and hypertension
- You are classified as underweight (<18.5 kg/m2), overweight (25-30 kg/m2), or obese (>30 kg/m2) using the BMI classification
- You are allergic to milk, eggs and egg protein
- You are claustrophobic (we will place a clear hood, which can easily be removed, over your head for approximately 20 min to measure your energy expenditure)
- You are currently enrolled in other research studies (as this may affect our study results)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dietary supplement: Arginine
Graded arginine excess intake
|
Graded arginine excess intake will start at 50mg/kg/d on study day 1 followed by 100 mg/kg/d on study day 2 till the level reaches 300mg/kg/d on study day 6. Consisting of oral consumption of eight hourly experimental meals per study day - Includes 4 tracer free experimental meals containing a mixture of free amino acids, calories from a flavored liquid and protein free cookies and 4- labeled amino acid experimental meals. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
13CO2 production
Time Frame: 8 hours (1 study day)
|
Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of tracer with graded intake of arginine
|
8 hours (1 study day)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rajavel Elango, PhD, University of British Columbia
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- H15-01151
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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