AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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.

Canada1 site
  • The Hospital for Sick Children

    Toronto, Ontario, M5G 1X8

Other trials in Canada

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 groups in NCT02008955
Study groupRoleWhat they receive
lysine intake at different levels of intakeExperimentalall 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.

  1. change in oxidation of phenylalanine in response to increasing lysine intake

    F13CO2

    Measured: 8 hours

Secondary outcomes (1)
  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.

  1. First posted11 Dec 2013 (estimated)
  2. Study start1 Jun 2019
  3. Primary completion30 Dec 2020
  4. Study completion30 Dec 2020

Resources

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)
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 25320185
  • Paoletti 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 42966566
  • Rafii 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

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.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in
Clinical Trial NCT02008955 | AzTrials