HealthyNCT04595188
Sulphur Amino Acid Requirements in Adults >60 Years
A study testing Sulphur amino acids in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
This study aims to determine the requirements for the sulphur amino acids in adults over the age of 60 years: 1. the total sulphur amino acid requirement as methionine only. Methionine is an essential amino acid. 2. the minimum methionine requirement as methionine in the presence of excess dietary cysteine. Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Sulphur amino acids
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteCanada
- Study dates
- 10 Oct 2020to 31 Dec 2022
- 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Consent provided
- Aged 60 to 90 years old
- In good general health as evidenced by medical history, physical health and blood draw
- Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine, vitamin-B6, vitamin- B12 and folate levels within normal ranges for age.
- Willingness to participate in the study.
- BMI <30 kg/m2.
Who cannot join
- Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, cancer, liver or kidney disease, acute cold or flu)
- Taking medications known to affect protein/AA metabolism (e.g. steroids)
- Inability to tolerate the diet (i.e. allergy)
- Significant weight loss during the past month or consumption of weight reducing diets.
- Significant caffeine consumption (>2 cups per day)
- Significant consumption of alcohol (>1 drink per day i.e. 1 beer or ½ glass of wine).
- Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Sulphur Amino Acid Requirements in Healthy Adults Over 60 Years
This study aims to determine the requirements for the sulphur amino acids in adults over the age of 60 years:
- the total sulphur amino acid requirement as methionine only. Methionine is an essential amino acid.
- the minimum methionine requirement as methionine in the presence of excess dietary cysteine.
Read more
It is known that protein and amino acid metabolism may be altered with age and methionine and cysteine, in particular, may be important in the diet of older adults.
Up to 7 different levels of methionine intake as methionine only (no dietary cysteine) and up to 7 different levels of methionine intake in the presence of excess dietary cysteine will be tested in each subject in random order. Each level of intake will involve a 3-day maintenance diet, with measures being collected on the third.
Read the detailed description
The sulphur amino acids (SAA) are methionine and cysteine. Methionine is essential and must be obtained from the diet whereas cysteine is considered non-essential and is synthesized from methionine. They have many other important roles that are secondary to their role in protein building. For example, they are needed to make the antioxidant glutathione (GSH), which protects the body's cells from damage. However, protein and GSH metabolism have been shown to change with age and hence, the SAA requirements may also be changed. Despite this, current SAA requirements are based on studies conducted in young adults. Thus, there is a need to determine the SAA requirements directly in older adults.
The purpose of the study is to apply the minimally invasive indicator amino acid oxidation (IAAO) protocol to determine the SAA requirements in healthy adults over 60 years of age. The requirements will be determined as (1) the total sulphur amino acid requirement as methionine only and (2) the minimum methionine requirement by providing methionine in the presence of excess dietary cysteine.
A pre-study assessment will be conducted to assess health status using: medical history and a physical exam; and a blood draw (10mL) for fasting blood glucose and hemoglobin A1c to test for diabetes, vitamin B and folate concentrations, and urea and creatinine to test renal function.
In order to determine the requirements, each participant will be studied at up to 7 varying intakes levels of methionine in random order. Each intake level will be studied over 3-days: two adaptation days (day 1 and 2) and one study day (day 3). On the adaptation days, participants will be provided with a milkshake diet providing all the protein and nutrients they need. Participants will consume 4 meals/day in their usual home environment. On the 3rd day participants will come to the Clinical Research Centre at SickKids where they will be given hourly meals and breath and urine samples at specified times.A blood sample will also be collected for analysis of serum insulin, glucose and secondary parameters (i.e. concentrations of amino acids, glutathione, homocysteine and CRP). The mean (estimate average requirement) total sulphur amino acid requirement and minimum methionine requirement will be calculated with breakpoint analysis using a two-phase linear regression crossover analysis.
- Conditions
- Healthy
- Being tested
- Sulphur amino acids
- Keywords
- elderly, amino acid requirement, methionine, cysteine, dietary requirement, sulphur amino acids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sulphur amino acidsOther
For the total sulphur amino acid requirement, there are 7 different methionine test levels (without dietary cysteine) ranging from 5 to 40 mg of methionine per kilogram body weight per day.
For the minimum methionine requirement, there are 7 different methionine test levels (with excess dietary cysteine).
| Study group | Role | What they receive |
|---|---|---|
| Sulphur amino acids in Adults > 60 | Experimental | Total sulphur amino acid, as methionine only: all subjects will receive up to 7 methionine test levels, without dietary cysteine, assigned in random order.
Minimum methionine, with excess dietary cysteine: all subjects will receive up to 7 methionine test levels, in the presence of excess and constant dietary cysteine, assigned in random order. Receives: Other: Sulphur amino acids |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of total sulphur amino acid requirements in adults >60 years of age
methionine requirement the presence of zero cysteine
Measured: up to 24 months
Secondary outcomes (1)
Determination of minimum sulphur amino acid requirements in adults >60 years of age
methionine requirement in the presence of excess cysteine
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start10 Oct 2020
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
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 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, MSc, PhD, RD, Principal investigator, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595188
- Sponsor's protocol ID
- 1000071600
- Status last verified
- Sep 2023
- First submitted
- 6 Oct 2020
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paoletti A, Pencharz PB, Ball RO, Kong D, Xu L, Elango R, Courtney-Martin G. The dietary requirement for total sulfur amino acids in adults aged >/=60 years appears to be higher in males than in females. Am J Clin Nutr. 2023 Sep;118(3):538-548. doi: 10.1016/j.ajcnut.2023.06.015. Epub 2023 Jun 24.
PubMed 37356549
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Sulphur Amino Acid Requirements in Healthy Adults Over 60 Years
- ClinicalTrials.gov ID
- NCT04595188
- Acronym / sponsor ID
- 1000071600
- Conditions
- Healthy
- Keywords
- elderly, amino acid requirement, methionine, cysteine, dietary requirement, sulphur amino acids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 10 Oct 2020 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- 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 requirements for the sulphur amino acids in adults over the age of 60 years:
- the total sulphur amino acid requirement as methionine only. Methionine is an essential amino acid.
- the minimum methionine requirement as methionine in the presence of excess dietary cysteine.
It is known that protein and amino acid metabolism may be altered with age and methionine and cysteine, in particular, may be important in the diet of older adults.
Up to 7 different levels of methionine intake as methionine only (no dietary cysteine) and up to 7 different levels of methionine intake in the presence of excess dietary cysteine will be tested in each subject in random order. Each level of intake will involve a 3-day maintenance diet, with measures being collected on the third.
Detailed description
The sulphur amino acids (SAA) are methionine and cysteine. Methionine is essential and must be obtained from the diet whereas cysteine is considered non-essential and is synthesized from methionine. They have many other important roles that are secondary to their role in protein building. For example, they are needed to make the antioxidant glutathione (GSH), which protects the body's cells from damage. However, protein and GSH metabolism have been shown to change with age and hence, the SAA requirements may also be changed. Despite this, current SAA requirements are based on studies conducted in young adults. Thus, there is a need to determine the SAA requirements directly in older adults.
The purpose of the study is to apply the minimally invasive indicator amino acid oxidation (IAAO) protocol to determine the SAA requirements in healthy adults over 60 years of age. The requirements will be determined as (1) the total sulphur amino acid requirement as methionine only and (2) the minimum methionine requirement by providing methionine in the presence of excess dietary cysteine.
A pre-study assessment will be conducted to assess health status using: medical history and a physical exam; and a blood draw (10mL) for fasting blood glucose and hemoglobin A1c to test for diabetes, vitamin B and folate concentrations, and urea and creatinine to test renal function.
In order to determine the requirements, each participant will be studied at up to 7 varying intakes levels of methionine in random order. Each intake level will be studied over 3-days: two adaptation days (day 1 and 2) and one study day (day 3). On the adaptation days, participants will be provided with a milkshake diet providing all the protein and nutrients they need. Participants will consume 4 meals/day in their usual home environment. On the 3rd day participants will come to the Clinical Research Centre at SickKids where they will be given hourly meals and breath and urine samples at specified times.A blood sample will also be collected for analysis of serum insulin, glucose and secondary parameters (i.e. concentrations of amino acids, glutathione, homocysteine and CRP). The mean (estimate average requirement) total sulphur amino acid requirement and minimum methionine requirement will be calculated with breakpoint analysis using a two-phase linear regression crossover analysis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sulphur amino acids in Adults > 60 | Experimental | Other: Sulphur amino acidsTotal sulphur amino acid, as methionine only: all subjects will receive up to 7 methionine test levels, without dietary cysteine, assigned in random order. Minimum methionine, with excess dietary cysteine: all subjects will receive up to 7 methionine test levels, in the presence of excess and constant dietary cysteine, assigned in random order. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Consent provided
- Aged 60 to 90 years old
- In good general health as evidenced by medical history, physical health and blood draw
- Fasting blood glucose, hemoglobin A1c (HbA1c), urea, creatinine, vitamin-B6, vitamin- B12 and folate levels within normal ranges for age.
- Willingness to participate in the study.
Key exclusion criteria (7 listed)
- Presence of chronic disease and/or acute illness known to affect protein/amino acid metabolism (e.g. HIV, diabetes, cancer, liver or kidney disease, acute cold or flu)
- Taking medications known to affect protein/AA metabolism (e.g. steroids)
- Inability to tolerate the diet (i.e. allergy)
- Significant weight loss during the past month or consumption of weight reducing diets.
- Significant caffeine consumption (>2 cups per day)
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 |
|---|---|---|
| Sulphur amino acidsFor the total sulphur amino acid requirement, there are 7 different methionine test levels (without dietary cysteine) ranging from 5 to 40 mg of methionine per kilogram body weight per day. For the minimum methionine requirement, there are 7 different methionine test levels (with excess dietary cysteine). | Other | Sulphur amino acids in Adults > 60 |
Primary outcome
Determination of total sulphur amino acid requirements in adults >60 years of age
Time frame: up to 24 months
methionine requirement the presence of zero cysteine
1 secondary outcome
Determination of minimum sulphur amino acid requirements in adults >60 years of age
Time frame: up to 24 months
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 13 Sep 2023.
- Derived from this study: PubMed 37356549Paoletti A, Pencharz PB, Ball RO, Kong D, Xu L, Elango R, Courtney-Martin G. The dietary requirement for total sulfur amino acids in adults aged >/=60 years appears to be higher in males than in females. Am J Clin Nutr. 2023 Sep;118(3):538-548. doi: 10.1016/j.ajcnut.2023.06.015. Epub 2023 Jun 24.
- Individual participant dataSharing planned: No
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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.
Glenda Courtney-Martin, MSc, PhD, RD 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 Sulphur amino acids 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 6 inclusion and 7 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 13 Sep 2023. 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?
Determination of total sulphur amino acid requirements in adults >60 years of age (time frame: up to 24 months). 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 NCT04595188, 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 13 Sep 2023.