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Glutathione (GSH) Synthesis in Healthy School-aged Children

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ClinicalTrials.gov Identifier: NCT02971046
Recruitment Status : Recruiting
First Posted : November 22, 2016
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Glenda Courtney-Martin, The Hospital for Sick Children

Brief Summary:
The fractional and absolute synthesis rates of GSH, an antioxidant that protects cells from damage, in the erythrocytes of healthy school-aged children in response to graded intakes of protein to determine if increasing the protein intake above the current recommended DRI produces increases in the GSH synthesis rates in erythrocytes of healthy school-aged children. Participants will consume specially formulated diets with varying protein levels.

Condition or disease Intervention/treatment Phase
Healthy Other: varying protein intakes Not Applicable

Detailed Description:

Glutathione (GSH) is important to protect the cells of the body. It is made from amino acids found in the protein obtained from foods we eat. This antioxidant is important to protect the cells of the body from damage. Low levels of GSH are found in healthy persons not getting enough protein in their diet. Inadequate protein intake in children not only compromises growth, but could increase susceptibility to, and compromise recovery from regular childhood illness. 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 current dietary reference intake (DRI) recommendations for protein in children between the ages of 6-11 years is based on nitrogen balance data and set at a mean (EAR) and population safe (RDA) recommendation of 0.76 and 0.95g.kg-1.d-1 respectively. Using the indicator amino oxidation (IAAO) method we estimated the mean and population safe protein requirement in the same age group of children to be 1.3 and 1.55g.kg-1.d-1 respectively.The purpose of this study therefore is to measure GSH synthesis in school aged children aged 6-11 years in response to current recommended protein intake and in response to protein requirement estimate derived using the IAAO method.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Glutathione (GSH) Synthesis in Response to Graded Protein Intakes: a Functional Measure of Protein Requirement in Healthy School-aged Children
Study Start Date : November 2016
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Glutathione

Arm Intervention/treatment
Experimental: Protein intake
Varying protein intakes.
Other: varying protein intakes
Four randomly assigned levels of protein intake in a repeated measured design.




Primary Outcome Measures :
  1. Erythrocyte GSH Fractional synthesis rates [ Time Frame: up to 13 months ]
    To measure the fractional synthesis rates of GSH in the erythrocytes of healthy school-aged children in response to graded intakes of protein.


Secondary Outcome Measures :
  1. Erythrocyte GSH absolute synthesis [ Time Frame: upt to 13 months ]
    To determine the absolute synthesis rate of GSH in erythrocyte of healthy school aged children in response to varying protein intakes.



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Body weight ≥ 22 kg
  • No history of anemia
  • Willingness to participate

Exclusion Criteria:

  • HIV
  • Diabetes
  • Anaemia
  • Significant weight loss within 30 days of study
  • On weight loss diets
  • Body weight less that 22kg
  • Inability to tolerate diet
  • Unwilling to have blood drawn

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02971046


Contacts
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Contact: Mary Ann Ryan, BComm 416-813-7454 maryann.ryan@sickkids.ca
Contact: Kaylem Boileau, BASc,MHSc(c) 416-813-7454 kaylem.boileau@sickkids.ca

Locations
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Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Mary Ann Ryan    416-813-7454      
Contact: Mahroukh Rafii    416-813-7454      
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Glenda Courtney-Martin, MSc, PhD    416-813-5744    glenda.courtney-martin@sickkids.ca   
Contact: Mahroukh Rafii, BSc.    416-813-7454    mahroukh.rafii@sickkids.ca   
Principal Investigator: Glenda Courtney-Martin, MSc., PhD         
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1x8
Contact: Mary Ann Ryan, BComm    (416) 813-7454    maryann.ryan@sickkids.ca   
Contact: Mahroukh Rafii, BSc    (416) 813-7454    mahroukh.rafii@sickkids.ca   
Principal Investigator: Glenda Courtney-Martin, RD PhD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
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Principal Investigator: Glenda Courtney-Martin, PhD Academic &Clinical Specialist

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Responsible Party: Glenda Courtney-Martin, Academic &Clinical Specialist, Project Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT02971046     History of Changes
Other Study ID Numbers: 1000053342
First Posted: November 22, 2016    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Glenda Courtney-Martin, The Hospital for Sick Children:
healthy children
protein
glutathione
protein requirement