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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Qualia Glutathione+ version 1 | Active Comparator | Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences |
|
| Qualia Glutathione+ version 2 | Active Comparator | Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences |
|
| Placebo | Placebo Comparator | Rice flour placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Qualia Glutathione+ version 1 | Dietary Supplement | Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total Glutathione levels from baseline to Day 20 | 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 | 0-20 days |
| Measure | Description | Time Frame |
|---|---|---|
| between-group differences in blood Total Glutathione levels | 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. | baseline to day 20 |
| within-group differences in the change in blood Glutathione levels |
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Inclusion criteria:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| William Scuba | Contact | 855-281-2328 | support@qualialife.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qualia Life Sciences | Carlsbad | California | 92011 | United States |
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| Qualia Glutathione+ version 2 | Dietary Supplement | Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences |
|
| Placebo | Dietary Supplement | Rice flour |
|
To assess within-group differences in the change in blood Glutathione levels |
| baseline to day 20 |
| Safety and Tolerability survey | To evaluate side effect profiles using a custom Safety and Tolerability survey. | baseline to days 7, 14 and 20 |
| PROMIS Global Health-10 | The PROMIS® Global Health Scale v1.2 (also known as the PROMIS-GH or PROMIS-10) is a 10-item, non-disease-specific questionnaire for adults to assess general physical and mental health. It yields two main scores, a Global Physical Health (GPH) T-score and a Global Mental Health (GMH) T-score, derived from four items each, to understand overall health perceptions. The scale is widely translated and free for use in clinical and research settings.
| baseline to days 7, 14 and 20 |
| PROMIS Short Form v1.0 - Fatigue 10a | The PROMIS Fatigue item banks assess a range of self-reported symptoms, from mild subjective feelings of tiredness to an overwhelming, debilitating, and sustained sense of exhaustion that likely decreases one's ability to execute daily activities and function normally in family or social roles. Fatigue is divided into the experience of fatigue (frequency, duration, and intensity) and the impact of fatigue on physical, mental, and social activities. The fatigue short forms are universal rather than disease-specific. All assess fatigue over the past seven days. Raw Score Minimum and Maximum: 10-50 the lower the better | baseline to days 7, 14 and 20 |
| PROMIS Cognitive Function - Short Form 8a | The PROMIS Cognitive Function v2.0 - Short Form 8a is an 8-item self-report questionnaire designed to assess perceived cognitive function over the past seven days. It measures difficulties in areas such as forming thoughts, concentration, attention, thinking speed, memory, and the ability to shift between tasks. - Raw Score Minimum and Maximum: 8-40 - The higher the score, the better | baseline to days 7, 14 and 20 |