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Lysine Oxidation in Response to Arginine Supplementation

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ClinicalTrials.gov Identifier: NCT02499926
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : July 18, 2017
Sponsor:
Information provided by (Responsible Party):
Rajavel Elango, PhD, University of British Columbia

Tracking Information
First Submitted Date  ICMJE July 14, 2015
First Posted Date  ICMJE July 16, 2015
Last Update Posted Date July 18, 2017
Study Start Date  ICMJE July 2015
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 14, 2015)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02499926 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lysine Oxidation in Response to Arginine Supplementation
Official Title  ICMJE Determination of Lysine Oxidation in Response to Arginine Supplementation in Adult Men Using in Vivo Stable Isotope Techniques
Brief Summary This research study is investigating if consuming more of one amino acid (arginine) influences the digestion and absorption of another amino acid (lysine) due to competition in digestion, in a healthy adult population.
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Condition  ICMJE Physiologically Healthy Adult Male Participants
Intervention  ICMJE Dietary Supplement: Arginine

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.

Study Arms  ICMJE Experimental: Dietary supplement: Arginine
Graded arginine excess intake
Intervention: Dietary Supplement: Arginine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: July 14, 2015)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2017
Estimated Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 19 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02499926
Other Study ID Numbers  ICMJE H15-01151
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Rajavel Elango, PhD, University of British Columbia
Study Sponsor  ICMJE University of British Columbia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rajavel Elango, PhD University of British Columbia
PRS Account University of British Columbia
Verification Date July 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP