To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine \[NAC\] and glycine) on reduced glutathione levels in healthy elderly subjects
This is a single-center, double-blind, randomized, placebo-controlled 4-arm study-design, to assess the safety, tolerability and effect of PRUVIN® on reduced glutathione levels in healthy elderly (age 60-85 years) subjects. In addition, baseline values of glutathione precursors, glutathione, and plasma markers of oxidative stress in a healthy young cohort (non-interventional) will be compared with those of the healthy elderly cohort (interventional).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Enrollment
128
Combination of N-acetylcysteine an glycine
Placebo as comparator to intervention
Profil Institut für Stoffwechselforschung GmbH
Neuss, Germany
Total reduced glutathione
Total reduced glutathione (GSH-T) in whole-blood normalized to hematocrit
Time frame: 2 weeks
Free reduced glutathione
Free reduced glutathione (GSH-F), free reduced glutathione to oxidized glutathione disulfide ratio (GSH-F:GSSG)
Time frame: 2 weeks
Hematocrit
Whole-blood concentrations of glycine and cysteine normalized to hematocrit
Time frame: 2 weeks
Lipid oxidation
Lipid oxidation derived from indirect calorimetry
Time frame: 2 weeks
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