NCT05041179

Bioavailability of PRUVIN® and Its Effects in Healthy Subjects (INDIGO)

Investigation on the Bioavailability of PRUVIN® and Its Effects on Physiologic-metabolic Biomarkers in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 128 (actual)
• Sponsor: Société des Produits Nestlé (SPN) · Industry
• Sex: All
• Age: 20 Years – 85 Years
• Healthy volunteers: Accepted

Summary

To evaluate the effect of different doses of PRUVIN® (N-acetylcysteine \[NAC\] and glycine) on reduced glutathione levels in healthy elderly subjects

Detailed description

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).

Conditions

• Oxidative Stress

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Pruvin R	Combination of N-acetylcysteine an glycine
OTHER	Isomaltulose	Placebo as comparator to intervention

Timeline

• Start date: 2019-04-01
• Primary completion: 2020-04-01
• Completion: 2020-05-01
• First posted: 2021-09-10
• Last updated: 2024-10-22

Locations

1 site across 1 country: Germany