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Completed
NCT07221955
The Impact of Qualia Gluthathione+ on Blood Glutathione Levels
Conditions: Effects of Qualia Glutathione+ on Blood Glutathione Levels, Glutathione
Sex: All
Ages: 45 Years – 75 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 56
Sponsor: Qualia Life Sciences
Location: Qualia Life Sciences Carlsbad California
Summary
This is a 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 assigned 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.
Eligibility Criteria
Inclusion criteria:
* Provide voluntary, written, informed consent to participate in the study
* Agree to provide a valid cell phone number and are willing to receive communications through text
* Can read and write English
* Willing to not begin taking any new supplements during the study and continue taking any supplements they are currently using regularly
* Willing to complete questionnaires, records, and diaries associated with the study.
* Healthy male and female participants aged 45-75 years
* Willing to go to a local blood draw location for a Whole Blood Total Glutathione measurement (baseline and Day 20)
* Willing to avoid starting new or stopping any existing dietary supplements throughout the study
Exclusion criteria:
* Women who are pregnant, breastfeeding, or planning to become pregnant during the trial
* Known food intolerances/allergy to any ingredients in the product
* Having any of the following conditions: Psychiatric conditions, neurologic disorders, endocrine disorders, cancer
* Having had a significant cardiovascular event in the past 6 months
* Taking MAO inhibitors, SSRIs, or any other psychiatric or neurological medicines
* On immunosuppressive therapy
* Adults lacking capacity to consent
* Active Smokers
* Diagnosed Diabetics
Source: ClinicalTrials.gov (NCT07221955). StuddyBuddy aggregates publicly available trial information.