Physiologically Healthy Adult Male ParticipantsNCT02499926
Lysine Oxidation in Response to Arginine Supplementation
A study testing Arginine in people with Physiologically Healthy Adult Male Participants, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Physiologically Healthy Adult Male Participants
- What is being tested?
- Arginine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteCanada
- Study dates
- Jul 2015to 12 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Canada1 site
BC Children;s Hospital Research Institute, University of British Columbia
Vancouver, British Columbia, V5Z4H4
About this study
Official title: Determination of Lysine Oxidation in Response to Arginine Supplementation in Adult Men Using in Vivo Stable Isotope Techniques
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.
Read the 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.
- Being tested
- Arginine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArginineDietary supplement
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 group | Role | What they receive |
|---|---|---|
| Dietary supplement: Arginine | Experimental | Graded arginine excess intake Receives: Dietary Supplement: Arginine |
What is being measured
The primary outcome is the main question the study is designed to answer.
13CO2 production
Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of tracer with graded intake of arginine
Measured: 8 hours (1 study day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionDec 2017
- Study completion12 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Physiologically Healthy Adult Male ParticipantsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, PhD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02499926
- Sponsor's protocol ID
- H15-01151
- Status last verified
- Jul 2024
- First submitted
- 14 Jul 2015
- Last updated
- 25 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of Lysine Oxidation in Response to Arginine Supplementation in Adult Men Using in Vivo Stable Isotope Techniques
- ClinicalTrials.gov ID
- NCT02499926
- Acronym / sponsor ID
- H15-01151
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Dec 2017 (actual)
- Study completion
- 12 Jan 2024 (actual)
- First posted
- 16 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Dietary supplement: Arginine | Experimental | Dietary Supplement: ArginineGraded arginine excess intake |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ArginineGraded 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. | Dietary supplement | Dietary supplement: Arginine |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajavel Elango, PhD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arginine in people with Physiologically Healthy Adult Male Participants, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
13CO2 production (time frame: 8 hours (1 study day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.