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Active, not recruiting Not applicable

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

NCT02971046 · tracked via the Priya Life Science Canada tracker
Phase
Not applicable
Started
2020-10-01
Last updated
2025-05-30

Condition(s) studied

Healthy

Investigational drug(s) / intervention(s)

varying protein intakes

varying protein intakes: 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 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
90 Years
Healthy volunteers
Accepted
Inclusion Criteria in: 1. Healthy school-aged children * Body weight ≥ 22 kg * No history of anemia * Willingness to participate 2. 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. 3. 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. Exclusion Criteria in: 1. 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 2. 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.

Primary outcome measure(s)

  • Erythrocyte GSH Fractional synthesis rates — 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.

Trial sites (1)

FacilityCityRegionStatus
The Hospital for Sick Children Toronto Ontario
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT02971046 on ClinicalTrials.gov ↗ ← All trials in Canada