HealthyNCT02971046
Glutathione (GSH) Synthesis in Healthy School-aged Children and Healthy Young and Old Adults
A study testing varying protein intakes in people with Healthy, run by The Hospital for Sick Children at 1 site in Canada.
Trial summary
To measure the fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from damage, in the erythrocytes of healthy school-aged children, young adults and old adults in response to graded intakes of protein in order to determine if increasing the protein intake above the current recommended… Read more about this study
- Who is it for?
- Ages 6 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- varying protein intakes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteCanada
- Study dates
- 1 Oct 2020to 30 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 6 to 90 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy school-aged children
- Body weight ≥ 22 kg
- No history of anemia
- Willingness to participate
- Healthy Young Adults
- Consent provided
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- Aged 19 - 40 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 <25 kg/m2.
- Healthy Old Adults
- Consent provided
- Aged 60- 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
- Healthy school-aged children
- HIV
- Diabetes
- Anaemia
- Significant weight loss within 30 days of study
- On weight loss diets
Show all 18Show fewer
- Body weight less that 22kg
- Inability to tolerate diet
- Unwilling to have blood drawn
- Healthy Young and Old Adults:
- Presence of chronic disease and/or acute illness known to affect GSH and/or protein/amino acid metabolism (e.g. HIV, diabetes, cancer, liver or kidney disease, acute cold or flu).
- Anemia (15 - 20% outside lower limit of normal lab reference ranges)
- Taking medications known to affect GSH and/or protein/AA metabolism (e.g. acetaminophen, steroids).
- 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).
- Inability to tolerate the diet
- Unwilling to have blood drawn from a venous access during the isotope infusion day.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Glutathione (GSH) Synthesis in Response to Graded Protein Intakes: a Functional Measure of Protein Requirement in Healthy School-aged Children and Healthy Young and Old Adults
To measure the fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from damage, in the erythrocytes of healthy school-aged children, young adults and old adults in response to graded intakes of protein in order to determine if increasing the protein intake above the current recommended DRI produces increases in the GSH synthesis rates in erythrocytes of these individuals. Participants will consume specially formulated diets with varying protein levels.
Read the detailed description
The current dietary reference intake (DRI) recommendations for protein in children (6-11 years old) and adults (>19 years old) are based on nitrogen balance data and set at a mean (EAR) of 0.76 and 0.66 g/kg/day respectively and population safe (RDA) recommendation of 0.95 and 0.80 g/kg/day respectively. Using the indicator amino oxidation (IAAO) method we estimated higher protein requirements in these populations. This suggests that current recommendations are underestimated. Studies in adults have shown that protein recommendation set on the basis of nitrogen balance data, while sufficient to maintain nitrogen balance, does not maintain GSH status.
Glutathione (GSH) is most important intracellular antioxidant and scavenger and its deficiency has been shown to compromise recovery in acute as well as chronic stressors. Deficiency of GSH results when protein and/or cysteine intake is inadequate. Inadequate protein intake in children not only compromises growth, but could increase susceptibility to, and compromise recovery from regular childhood illness. Similarly, in young and older adults' inadequate intakes may result in increased oxidative stress and compromised immune function. Measurement of GSH synthesis provides a functional method whereby the current protein recommendation can be tested against higher estimates derived using the IAAO method. The purpose of this study therefore is to measure GSH synthesis in healthy school aged children (6-11 years), and healthy young (19 - 40 years) and old (60 - 90 years) adults in response to current recommended protein intakes and in response to protein requirement estimates derived using the IAAO method.
In healthy school-aged children, each level of protein will be studied over three days. For two days (adaptation days), participants will eat some low protein foods plus a milkshake drink. On the study day, participants will consume 8 hourly protein drinks and special cookies at SickKids. In healthy young and old adults, each level of protein will be studied over three days. For two days (adaptation days), young adults will eat some low protein foods plus a milkshake drink. On the one study day, young adults will consume 10 hourly milkshake diets at SickKids. In old adults, each level of protein will be studied over four days. For three days (adaptation days), old adults will eat some low protein foods plus a milkshake drink. On the one study day, old adults will consume 10 hourly milkshake diets at SickKids.
- Conditions
- Healthy
- Being tested
- varying protein intakes
- Keywords
- healthy children, protein, glutathione, protein requirement, healthy young adults, healthy adults over 60 years of age
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
varying protein intakesOther
In healthy school-aged children: Four randomly assigned levels of protein intake in a repeated measured design. The levels of protein intake are 0.95, 1.3,1.55, and 2.0 grams per kilogram of bodyweight per day.
In healthy young and old adults: Up to six randomly assigned levels of protein intake in a repeated measured design. The levels of protein intake are : 0.66, 0.8, 1, 1.2, and 1.5 grams per kilogram of bodyweight per day.
| Study group | Role | What they receive |
|---|---|---|
| Protein intake | Experimental | Varying protein intakes. Receives: Other: varying protein intakes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Erythrocyte GSH Fractional synthesis rates
To measure the fractional synthesis rates of GSH in the erythrocytes of healthy school-aged children and healthy young and old adults in response to graded intakes of protein.
Measured: up to 24 months
Secondary outcomes (1)
Erythrocyte GSH absolute synthesis
To determine the absolute synthesis rate of GSH in erythrocyte of healthy school aged children and healthy young and old adults in response to varying protein intakes.
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 posted22 Nov 2016 (estimated)
- Study start1 Oct 2020
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Glenda Courtney-Martin, The Hospital for Sick Children
- Investigators
- Glenda Courtney-Martin, PhD, Principal investigator, Academic &Clinical Specialist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02971046
- Sponsor's protocol ID
- 1000053342
- Status last verified
- May 2025
- First submitted
- 11 Nov 2016
- Last updated
- 30 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Paoletti A, Pencharz PB, Rafii M, Tomlinson C, Kong D, Xu L, Elango R, Courtney-Martin G. Protein intake affects erythrocyte glutathione synthesis in healthy adults aged >/=60 years in a repeated-measures trial. Am J Clin Nutr. 2024 Apr;119(4):917-926. doi: 10.1016/j.ajcnut.2024.02.002. Epub 2024 Feb 5.
PubMed 38325765Szwiega S, Xu L, Rafii M, Pencharz PB, Kong D, Tomlinson C, Elango R, Courtney-Martin G. Protein intake affects erythrocyte glutathione synthesis in young healthy adults in a repeated-measures trial. Am J Clin Nutr. 2024 Feb;119(2):371-383. doi: 10.1016/j.ajcnut.2023.11.008. Epub 2023 Nov 20.
PubMed 37992970
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutathione (GSH) Synthesis in Response to Graded Protein Intakes: a Functional Measure of Protein Requirement in Healthy School-aged Children and Healthy Young and Old Adults
- ClinicalTrials.gov ID
- NCT02971046
- Acronym / sponsor ID
- 1000053342
- Conditions
- Healthy
- Keywords
- healthy children, protein, glutathione, protein requirement, healthy young adults, healthy adults over 60 years of age
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Study start
- 1 Oct 2020 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2027 (estimated)
- First posted
- 22 Nov 2016 (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.
To measure the fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from damage, in the erythrocytes of healthy school-aged children, young adults and old adults in response to graded intakes of protein in order to determine if increasing the protein intake above the current recommended DRI produces increases in the GSH synthesis rates in erythrocytes of these individuals. Participants will consume specially formulated diets with varying protein levels.
Detailed description
The current dietary reference intake (DRI) recommendations for protein in children (6-11 years old) and adults (>19 years old) are based on nitrogen balance data and set at a mean (EAR) of 0.76 and 0.66 g/kg/day respectively and population safe (RDA) recommendation of 0.95 and 0.80 g/kg/day respectively. Using the indicator amino oxidation (IAAO) method we estimated higher protein requirements in these populations. This suggests that current recommendations are underestimated. Studies in adults have shown that protein recommendation set on the basis of nitrogen balance data, while sufficient to maintain nitrogen balance, does not maintain GSH status.
Glutathione (GSH) is most important intracellular antioxidant and scavenger and its deficiency has been shown to compromise recovery in acute as well as chronic stressors. Deficiency of GSH results when protein and/or cysteine intake is inadequate. Inadequate protein intake in children not only compromises growth, but could increase susceptibility to, and compromise recovery from regular childhood illness. Similarly, in young and older adults' inadequate intakes may result in increased oxidative stress and compromised immune function. Measurement of GSH synthesis provides a functional method whereby the current protein recommendation can be tested against higher estimates derived using the IAAO method. The purpose of this study therefore is to measure GSH synthesis in healthy school aged children (6-11 years), and healthy young (19 - 40 years) and old (60 - 90 years) adults in response to current recommended protein intakes and in response to protein requirement estimates derived using the IAAO method.
In healthy school-aged children, each level of protein will be studied over three days. For two days (adaptation days), participants will eat some low protein foods plus a milkshake drink. On the study day, participants will consume 8 hourly protein drinks and special cookies at SickKids. In healthy young and old adults, each level of protein will be studied over three days. For two days (adaptation days), young adults will eat some low protein foods plus a milkshake drink. On the one study day, young adults will consume 10 hourly milkshake diets at SickKids. In old adults, each level of protein will be studied over four days. For three days (adaptation days), old adults will eat some low protein foods plus a milkshake drink. On the one study day, old adults will consume 10 hourly milkshake diets at SickKids.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Protein intake | Experimental | Other: varying protein intakesVarying protein intakes. |
Who may qualify
- Ages
- 6 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (18 listed)
- Healthy school-aged children
- Healthy Young Adults
- Healthy Old Adults
Key exclusion criteria (18 listed)
- Healthy school-aged children
- Healthy Young and Old Adults:
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 |
|---|---|---|
| varying protein intakesIn healthy school-aged children: Four randomly assigned levels of protein intake in a repeated measured design. The levels of protein intake are 0.95, 1.3,1.55, and 2.0 grams per kilogram of bodyweight per day. In healthy young and old adults: Up to six randomly assigned levels of protein intake in a repeated measured design. The levels of protein intake are : 0.66, 0.8, 1, 1.2, and 1.5 grams per kilogram of bodyweight per day. | Other | Protein intake |
Primary outcome
Erythrocyte GSH Fractional synthesis rates
Time frame: up to 24 months
To measure the fractional synthesis rates of GSH in the erythrocytes of healthy school-aged children and healthy young and old adults in response to graded intakes of protein.
1 secondary outcome
Erythrocyte GSH absolute synthesis
Time frame: up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Derived from this study: PubMed 38325765Paoletti A, Pencharz PB, Rafii M, Tomlinson C, Kong D, Xu L, Elango R, Courtney-Martin G. Protein intake affects erythrocyte glutathione synthesis in healthy adults aged >/=60 years in a repeated-measures trial. Am J Clin Nutr. 2024 Apr;119(4):917-926. doi: 10.1016/j.ajcnut.2024.02.002. Epub 2024 Feb 5.
- Derived from this study: PubMed 37992970Szwiega S, Xu L, Rafii M, Pencharz PB, Kong D, Tomlinson C, Elango R, Courtney-Martin G. Protein intake affects erythrocyte glutathione synthesis in young healthy adults in a repeated-measures trial. Am J Clin Nutr. 2024 Feb;119(2):371-383. doi: 10.1016/j.ajcnut.2023.11.008. Epub 2023 Nov 20.
- 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, PhD principal investigator
Academic &Clinical Specialist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing varying protein intakes 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 18 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 30 May 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Erythrocyte GSH Fractional synthesis rates (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 NCT02971046, which also lists 2 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 30 May 2025.