Elderly MenNCT02095080
Determination of the UL of Leucine in Healthy Elderly Men
A study testing Leucine intake in people with Elderly Men, run by University of British Columbia at 1 site in Canada.
Trial summary
Amino acid are the building blocks of the body's protein. Some amino acids, including leucine, cannot be made in the body and must be obtained from diet, these are called essential. Read more about this study
- Who is it for?
- Ages 70 to 75 years, men only
- Conditions the study is for
- Elderly Men
- What is being tested?
- Leucine intake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2014to Dec 2015
- 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 70 to 75 years
- Men only
- No healthy volunteers
- Older adult
Who may be able to join
- Men 70 - 75 years of age
- Free of chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and or diabetes.
- Free of any cognitive disorders
- Men not enrolled in any other research studies
- Men who are not claustrophobic
Who cannot join
- Men not within the age 70 -75 years
- Men diagnosed with a chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and/or diabetes
- Men allergic to milk, eggs and egg protein
- Men who are claustrophobic
- Men who are currently enrolled in other research studies
Trial locations and contacts
1 site in 1 country.
Canada1 site
Child & Family Research Institute
Vancouver, British Columbia, V5Z 4H4
About this study
Official title: Determination of the Tolerable Upper Intake Level (UL) of Leucine in Healthy Elderly Men (70-75 Yrs)
Amino acid are the building blocks of the body's protein. Some amino acids, including leucine, cannot be made in the body and must be obtained from diet, these are called essential. With increase in age the body's muscle mass decrease and studies have suggested that dietary supplementation of leucine may have potential health benefits in elderly in regards to prevention of age related loss of lean muscle mass, and thus may help improve the quality of life in elderly.
Currently, a safe upper dietary intake level of leucine has not been established for healthy elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy elderly.
Read more
The purpose of this study is to determine the tolerable upper intake level (UL) of leucine in healthy elderly men (70 - 75 yrs)
The investigators hypothesize that with a careful graded stepwise increase in leucine intake in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's ability to oxidize/dispose of excess amino acids will reach a maximum. With increased leucine intakes we hypothesize an increase in plasma ammonia concentrations and increases in plasma leucine and urinary leucine excretion.
- Conditions
- Elderly Men
- Being tested
- Leucine intake
- Keywords
- Leucine, Upper Intake Level (UL), Elderly, Amino acids, Protein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Leucine intakeDietary supplement
Oral consumption of eight hourly experimental meals- 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 |
|---|---|---|
| Leucine intake | Experimental | Dietary supplement: Leucine intake Receives: Dietary Supplement: Leucine intake |
What is being measured
The primary outcome is the main question the study is designed to answer.
13 carbon dioxide production
Urine, plasma and breath samples will be collected during the study to measure the rate of oxidation of the tracer.
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 posted24 Mar 2014 (estimated)
- Study startAug 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Elderly MenStudies 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
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Collaborators
- International Council on Amino Acid Science
- Responsible party
- Principal investigator, Rajavel Elango, PhD, University of British Columbia
- Investigators
- Rajavel Elango, PhD, Principal investigator, Child & Family Research Institute/University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095080
- Sponsor's protocol ID
- H14-00235
- Status last verified
- Jul 2017
- First submitted
- 19 Mar 2014
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rasmussen B, Gilbert E, Turki A, Madden K, Elango R. Determination of the safety of leucine supplementation in healthy elderly men. Amino Acids. 2016 Jul;48(7):1707-16. doi: 10.1007/s00726-016-2241-0. Epub 2016 Apr 30.
PubMed 27138628
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Tolerable Upper Intake Level (UL) of Leucine in Healthy Elderly Men (70-75 Yrs)
- ClinicalTrials.gov ID
- NCT02095080
- Acronym / sponsor ID
- H14-00235
- Conditions
- Elderly Men
- Keywords
- Leucine, Upper Intake Level (UL), Elderly, Amino acids, Protein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Collaborators
- International Council on Amino Acid Science
- Study start
- Aug 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 24 Mar 2014 (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.
Amino acid are the building blocks of the body's protein. Some amino acids, including leucine, cannot be made in the body and must be obtained from diet, these are called essential. With increase in age the body's muscle mass decrease and studies have suggested that dietary supplementation of leucine may have potential health benefits in elderly in regards to prevention of age related loss of lean muscle mass, and thus may help improve the quality of life in elderly.
Currently, a safe upper dietary intake level of leucine has not been established for healthy elderly. Prior to exploring whether leucine supplementation will prevent or decrease loss of lean muscle mass in elderly we propose to identify the upper intake of leucine in healthy elderly.
The purpose of this study is to determine the tolerable upper intake level (UL) of leucine in healthy elderly men (70 - 75 yrs)
The investigators hypothesize that with a careful graded stepwise increase in leucine intake in elderly men, above the Estimated Average Requirement (EAR - 50 mg/kg/d), the body's ability to oxidize/dispose of excess amino acids will reach a maximum. With increased leucine intakes we hypothesize an increase in plasma ammonia concentrations and increases in plasma leucine and urinary leucine excretion.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Leucine intake | Experimental | Dietary Supplement: Leucine intakeDietary supplement: Leucine intake |
Who may qualify
- Ages
- 70 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Men 70 - 75 years of age
- Free of chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and or diabetes.
- Free of any cognitive disorders
- Men not enrolled in any other research studies
- Men who are not claustrophobic
Key exclusion criteria (5 listed)
- Men not within the age 70 -75 years
- Men diagnosed with a chronic diseases including; sarcopenia, heart disease, kidney disorders, liver disease, chronic high blood pressure and/or diabetes
- Men allergic to milk, eggs and egg protein
- Men who are claustrophobic
- Men who are currently enrolled in other research studies
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 |
|---|---|---|
| Leucine intakeOral consumption of eight hourly experimental meals- 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 | Leucine intake |
Primary outcome
13 carbon dioxide 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 the tracer.
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 18 Jul 2017.
- Derived from this study: PubMed 27138628Rasmussen B, Gilbert E, Turki A, Madden K, Elango R. Determination of the safety of leucine supplementation in healthy elderly men. Amino Acids. 2016 Jul;48(7):1707-16. doi: 10.1007/s00726-016-2241-0. Epub 2016 Apr 30.
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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
Child & Family Research Institute/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 Leucine intake in people with Elderly Men, 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 5 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 18 Jul 2017. 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?
13 carbon dioxide 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?
On the ClinicalTrials.gov record for NCT02095080, which also lists 1 linked publication.
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 18 Jul 2017.