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The Impact of Qualia Gluthathione+ on Blood Glutathione Levels

Not Applicable
Not yet recruiting
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
Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Total Glutathione levels from baseline to Day 200-20 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
NameTimeMethod
Survey Assessmentsbaseline 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 levelsbaseline 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 levelsbaseline to day 20

To assess within-group differences in the change in blood Glutathione levels

Safety and Tolerability surveybaseline 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 States
Study Coordinator
Contact
855-281-2328
support@qualialife.com

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