NCT02971046

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

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 55 (estimated)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: All
• Age: 6 Years – 90 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
OTHER	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.

Timeline

• Start date: 2020-10-01
• Primary completion: 2027-11-30
• Completion: 2027-11-30
• First posted: 2016-11-22
• Last updated: 2025-05-30

Locations

1 site across 1 country: Canada