The Impact of Qualia Gluthathione+ on Blood Glutathione Levels
- Conditions
- Test the Effects of Qualia Glutathione+ on Glutathione Levels in the Blood
- Registration Number
- NCT07221955
- Lead Sponsor
- Qualia Life Sciences
- Brief Summary
This is a randomized, double-blind, placebo-controlled, parallel-group, triple-armed, study evaluating the effects of two distinct Qualia Glutathione+ formulations on Whole Blood Glutathione levels in the blood of healthy adults aged 45-75 years. Approximately 18 participants will be randomized to one of three study arms: Qualia Glutathione+ version 1, Qualia Glutathione+ version 2, or placebo. Each participant will take two or three capsules of their assigned product once daily in the morning, with or without food, over a 20-day period. The primary outcome is the change in blood glutathione levels, assessed via in lab blood collection at baseline and study completion. Secondary endpoints include questionnaires measuring health-related quality of life, fatigue, and cognitive functioning (PROMIS Global Health-10, PROMIS Short Form v1.0 - Fatigue 10a, PROMIS Cognitive Function - Short Form 8a), evaluation of safety and tolerability, and an Overall Experience Questionnaire (Appendices 1, 4-7). All assessments, including electronic questionnaires, are completed remotely without in-person visits.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 54
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Total Glutathione levels from baseline to Day 20 0-20 days To assess between-group differences in the change in blood Total Glutathione levels from baseline to Day 20 following supplementation with Qualia Glutathione version 1 versus placebo and Qualia Glutathione version 2 versus placebo
- Secondary Outcome Measures
Name Time Method Survey Assessments baseline to days 7, 14 and 20 To assess within-group and between-group differences in PROMIS Global Health-10, PROMIS Short Form v1.0 - Fatigue 10a, PROMIS Cognitive Function - Short Form 8a domain scores.
between-group differences in blood Total Glutathione levels baseline to day 20 To assess the between-group differences in blood Total Glutathione levels from baseline to Day 20 following supplementation between Qualia Glutathione version 1 and Qualia Glutathione version 2.
within-group differences in the change in blood Glutathione levels baseline to day 20 To assess within-group differences in the change in blood Glutathione levels
Safety and Tolerability survey baseline to days 7, 14 and 20 To evaluate side effect profiles using a custom Safety and Tolerability survey.
Trial Locations
- Locations (1)
Qualia Life Sciences
🇺🇸Carlsbad, California, United States
Qualia Life Sciences🇺🇸Carlsbad, California, United StatesStudy CoordinatorContact855-281-2328support@qualialife.com
