Glutathione (GSH) Synthesis in Healthy School-aged Children and Healthy Young and Old Adults

NCT02971046 | Active Not Recruiting

• 1 other identifier: 1000053342
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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 DRI produces increases in the GSH synthesis rates in erythrocytes of these individuals. Participants will consume specially formulated diets with varying protein levels.

Conditions

Healthy

Keywords

healthy children; protein; glutathione; protein requirement; healthy young adults; healthy adults over 60 years of age

Outcome Measures

Primary Outcomes (1)

• 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.

  up to 24 months

Secondary Outcomes (1)

• Erythrocyte GSH absolute synthesis

  up to 24 months

Study Arms (1)

Protein intake

EXPERIMENTAL

Varying protein intakes.

Other: varying protein intakes

Interventions

varying protein intakes OTHER

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.

Protein intake

Eligibility Criteria

• Age: 6 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy school-aged children
• Body weight ≥ 22 kg
• No history of anemia
• Willingness to participate
• Healthy Young Adults
• Consent provided
• 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

You may not qualify if:

• Healthy school-aged children
• 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
• 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).

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Related Publications (2)

• 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.

  PMID: 38325765 DERIVED

• Szwiega 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.

  PMID: 37992970 DERIVED

Study Officials

• Glenda Courtney-Martin, PhD

  Academic &Clinical Specialist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Academic &Clinical Specialist, Project Investigator

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 22, 2016
• Study Start: October 1, 2020
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2027
• Last Updated: May 30, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)