HealthyNCT02008955
Lysine Requirement of Elderly Men and Women Over 60 Years of Age
A study testing Lysine intake provided as a milkshake in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study aims to determine the requirement for lysine in men and women over the age of 60 years. Seven different levels of lysine intake will be tested in each subject in random order. Read more about this study
- Who is it for?
- Ages 60 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Lysine intake provided as a milkshake
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jun 2019to 30 Dec 2020
- 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 60 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 60 + years old
- non diabetic
- not obese
- willing to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire)
Who cannot join
- obese (BMI greater than 30 kg/m2)
- recent history of weight loss or weight gain
- presence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
- On medications known to affect protein and amino acid metabolism (steroids)
- Inability to tolerate the diet
- Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
Show all 9Show fewer
- Significant coffee consumption of more than 2 cups/day
- Significant alcohol consumption of more than one drink/day
- smoking
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Determination Of Lysine Requirement in Adults Over 60 Years Using the Indicator Amino Acid Oxidation (IAAO) Method
This study aims to determine the requirement for lysine in men and women over the age of 60 years.
Seven different levels of lysine intake will be tested in each subject in random order. Each level of lysine intake will involve a 3-day maintenance diet, with measures (breath, urine, and blood samples) being collected on the third.
Read the detailed description
Lysine is an amino acid that is essential in the diet. In our body, lysine makes up protein. It is known that as people get older, over the age of 60, our body goes through many changes such as increase in fat mass and decrease in lean mass such as muscle. This is why we are studying how much of the essential amino acid, lysine, the body needs at this particular age.
The indicator amino acid oxidation (IAAO) method is a minimally invasive method for determining essential amino acid requirements.
As essential amino acids cannot be stored in the body, they are either partitioned into protein synthesis or oxidized if in excess. The premise of the IAAO is that when any essential amino acid is limiting in the body then all other amino acids lose their ability to contribute to protein synthesis and are instead oxidized. The method therefore involves providing graded intakes (from deficient to excess) of the test amino acid, lysine, and then measuring the oxidation of another amino acid, which is called the indicator amino acid. This is done by isotopically labelling the indicator amino acid (13C- phenylalanine) and then measuring the appearance of labelled carbon dioxide (13CO2) in breath with the different intakes of the test amino acid, lysine. The requirement for lysine will be determined by the "breakpoint" - the point at which oxidation of 13C- phenylalanine will plateau.
For the study, participants will first participate in a pre-study assessment in which height, weight, body composition (fat mass and muscle mass) and resting energy expenditure and medical history will be assessed. Also, 5 ml of blood will be collected to test for diabetes and kidney function. The purpose of the pre-assessment is to calculate the participant's dietary requirements for the study, and to assess health status, activity level and dietary patterns.
Participants will then participate in up to 7 different 3-day studies that will be separated by a minimum of 1 week between each 3-day study. The first 2 days are adaptation days and participants will consumed the maintenance diet at home as 4 equal meals. The 3rd day is called a study day and participants will consumed 8 hourly formulas; the first 3 are consumed at home and the remaining 5 are consumed at the Clinical Research Centre at the Hospital for Sick Children. Immediately after the 4th meal, 4 baseline breath and 3 baseline urine samples are collected over the period of an hour. After the 5th meal, rate of carbon dioxide production (VCO2) is measured by indirect calorimetry for a period of 20 minutes. The 5th, 6th, 7th, and 8th meal will contain a small amount of isotope labelled phenylalanine (13C phenylalanine). Two and a half hours after the isotope (13C phenylalanine) is given (between meal 7 and 8) 4 plateau breath and 3 plateau urine samples are collected for a period of an hour. Between the 7th and 8th meal, a 15 ml blood sample will be taken - 10 ml will be used to check for glucose and insulin levels and the remaining 5 ml for amino acid analysis.
Breath samples are used to measure the enrichment of isotopic labelled CO2 (13CO2). Urine samples are used to measure the enrichment of isotopic labelled phenylalanine (13C phenylalanine). Through a series of calculations and applying a two-phase regression analysis, we will be able to determine the requirement for lysine.
- Conditions
- Healthy
- Being tested
- Lysine intake provided as a milkshake
- Keywords
- lysine, elderly, amino acid requirement, diet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lysine intake provided as a milkshakeDietary supplement
There are 7 different lysine test levels ranging from 10 to 80 mg of lysine per kilogram body weight per day (10 - 80 mg/kg/d)
| Study group | Role | What they receive |
|---|---|---|
| lysine intake at different levels of intake | Experimental | all subjects will receive all 7 of the lysine test levels, assigned in random order. Receives: Dietary Supplement: Lysine intake provided as a milkshake |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in oxidation of phenylalanine in response to increasing lysine intake
F13CO2
Measured: 8 hours
Secondary outcomes (1)
phenylalanine oxidations determined from urinary phenylalanine enrichments
phenylalanine oxidation (phe OX)
Measured: 8 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start1 Jun 2019
- Primary completion30 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Paul Pencharz, The Hospital for Sick Children
- Investigators
- Paul Pencharz, PhD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008955
- Sponsor's protocol ID
- 0019850580 E
- Status last verified
- Feb 2021
- First submitted
- 8 Dec 2013
- Last updated
- 17 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rafii M, Chapman K, Owens J, Elango R, Campbell WW, Ball RO, Pencharz PB, Courtney-Martin G. Dietary protein requirement of female adults >65 years determined by the indicator amino acid oxidation technique is higher than current recommendations. J Nutr. 2015 Jan;145(1):18-24. doi: 10.3945/jn.114.197517. Epub 2014 Oct 15.
PubMed 25320185Paoletti A, Naeem W, Pencharz PB, Tomlinson C, Rafii M, Kong D, Li B, Elango R, Courtney-Martin G. Dietary threonine requirement of healthy older adults >60y stratified by age and sex in a repeated measures design1. Am J Clin Nutr. 2026 Oct 31:101619. doi: 10.1016/j.ajcnut.2026.101619. Online ahead of print.
PubMed 42966566Rafii M, Paoletti A, He H, Porto B, Szwiega S, Pencharz PB, Ball RO, Kong D, Xu L, Elango R, Courtney-Martin G. Dietary Lysine Requirements of Older Adults Stratified by Age and Sex. J Nutr. 2024 Jul;154(7):2133-2142. doi: 10.1016/j.tjnut.2024.04.034. Epub 2024 May 11.
PubMed 38735574
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination Of Lysine Requirement in Adults Over 60 Years Using the Indicator Amino Acid Oxidation (IAAO) Method
- ClinicalTrials.gov ID
- NCT02008955
- Acronym / sponsor ID
- 0019850580 E
- Conditions
- Healthy
- Keywords
- lysine, elderly, amino acid requirement, diet
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 30 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 11 Dec 2013 (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 study aims to determine the requirement for lysine in men and women over the age of 60 years.
Seven different levels of lysine intake will be tested in each subject in random order. Each level of lysine intake will involve a 3-day maintenance diet, with measures (breath, urine, and blood samples) being collected on the third.
Detailed description
Lysine is an amino acid that is essential in the diet. In our body, lysine makes up protein. It is known that as people get older, over the age of 60, our body goes through many changes such as increase in fat mass and decrease in lean mass such as muscle. This is why we are studying how much of the essential amino acid, lysine, the body needs at this particular age.
The indicator amino acid oxidation (IAAO) method is a minimally invasive method for determining essential amino acid requirements.
As essential amino acids cannot be stored in the body, they are either partitioned into protein synthesis or oxidized if in excess. The premise of the IAAO is that when any essential amino acid is limiting in the body then all other amino acids lose their ability to contribute to protein synthesis and are instead oxidized. The method therefore involves providing graded intakes (from deficient to excess) of the test amino acid, lysine, and then measuring the oxidation of another amino acid, which is called the indicator amino acid. This is done by isotopically labelling the indicator amino acid (13C- phenylalanine) and then measuring the appearance of labelled carbon dioxide (13CO2) in breath with the different intakes of the test amino acid, lysine. The requirement for lysine will be determined by the "breakpoint" - the point at which oxidation of 13C- phenylalanine will plateau.
For the study, participants will first participate in a pre-study assessment in which height, weight, body composition (fat mass and muscle mass) and resting energy expenditure and medical history will be assessed. Also, 5 ml of blood will be collected to test for diabetes and kidney function. The purpose of the pre-assessment is to calculate the participant's dietary requirements for the study, and to assess health status, activity level and dietary patterns.
Participants will then participate in up to 7 different 3-day studies that will be separated by a minimum of 1 week between each 3-day study. The first 2 days are adaptation days and participants will consumed the maintenance diet at home as 4 equal meals. The 3rd day is called a study day and participants will consumed 8 hourly formulas; the first 3 are consumed at home and the remaining 5 are consumed at the Clinical Research Centre at the Hospital for Sick Children. Immediately after the 4th meal, 4 baseline breath and 3 baseline urine samples are collected over the period of an hour. After the 5th meal, rate of carbon dioxide production (VCO2) is measured by indirect calorimetry for a period of 20 minutes. The 5th, 6th, 7th, and 8th meal will contain a small amount of isotope labelled phenylalanine (13C phenylalanine). Two and a half hours after the isotope (13C phenylalanine) is given (between meal 7 and 8) 4 plateau breath and 3 plateau urine samples are collected for a period of an hour. Between the 7th and 8th meal, a 15 ml blood sample will be taken - 10 ml will be used to check for glucose and insulin levels and the remaining 5 ml for amino acid analysis.
Breath samples are used to measure the enrichment of isotopic labelled CO2 (13CO2). Urine samples are used to measure the enrichment of isotopic labelled phenylalanine (13C phenylalanine). Through a series of calculations and applying a two-phase regression analysis, we will be able to determine the requirement for lysine.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lysine intake at different levels of intake | Experimental | Dietary Supplement: Lysine intake provided as a milkshakeall subjects will receive all 7 of the lysine test levels, assigned in random order. |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 60 + years old
- non diabetic
- not obese
- willing to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire)
Key exclusion criteria (9 listed)
- obese (BMI greater than 30 kg/m2)
- recent history of weight loss or weight gain
- presence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.
- On medications known to affect protein and amino acid metabolism (steroids)
- Inability to tolerate the diet
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 |
|---|---|---|
| Lysine intake provided as a milkshakeThere are 7 different lysine test levels ranging from 10 to 80 mg of lysine per kilogram body weight per day (10 - 80 mg/kg/d) | Dietary supplement | lysine intake at different levels of intake |
Primary outcome
change in oxidation of phenylalanine in response to increasing lysine intake
Time frame: 8 hours
F13CO2
1 secondary outcome
phenylalanine oxidations determined from urinary phenylalanine enrichments
Time frame: 8 hrs
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 17 Feb 2021.
- Background: PubMed 25320185Rafii M, Chapman K, Owens J, Elango R, Campbell WW, Ball RO, Pencharz PB, Courtney-Martin G. Dietary protein requirement of female adults >65 years determined by the indicator amino acid oxidation technique is higher than current recommendations. J Nutr. 2015 Jan;145(1):18-24. doi: 10.3945/jn.114.197517. Epub 2014 Oct 15.
- Derived from this study: PubMed 42966566Paoletti A, Naeem W, Pencharz PB, Tomlinson C, Rafii M, Kong D, Li B, Elango R, Courtney-Martin G. Dietary threonine requirement of healthy older adults >60y stratified by age and sex in a repeated measures design1. Am J Clin Nutr. 2026 Oct 31:101619. doi: 10.1016/j.ajcnut.2026.101619. Online ahead of print.
- Derived from this study: PubMed 38735574Rafii M, Paoletti A, He H, Porto B, Szwiega S, Pencharz PB, Ball RO, Kong D, Xu L, Elango R, Courtney-Martin G. Dietary Lysine Requirements of Older Adults Stratified by Age and Sex. J Nutr. 2024 Jul;154(7):2133-2142. doi: 10.1016/j.tjnut.2024.04.034. Epub 2024 May 11.
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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.
Paul Pencharz, PhD principal investigator
The Hospital for Sick Children
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lysine intake provided as a milkshake in people with Healthy, run by The Hospital for Sick Children 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 4 inclusion and 9 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 17 Feb 2021. 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?
change in oxidation of phenylalanine in response to increasing lysine intake (time frame: 8 hours). 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 NCT02008955, which also lists 3 linked publications.
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 17 Feb 2021.