Qualia Life Sciences
Carlsbad, California, 92011, United States
NCT Number: NCT07221955
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.
Trial opening soon.
Get Notified45 year–75 year
All sexes
Interventional
Not applicable
Carlsbad, California, 92011, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences
Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences
Rice flour
Time frame: 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
Time frame: 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.
Time frame: baseline to day 20
To assess within-group differences in the change in blood Glutathione levels
Time frame: baseline to days 7, 14 and 20
To evaluate side effect profiles using a custom Safety and Tolerability survey.
Time frame: baseline to days 7, 14 and 20
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.
Time frame: baseline to days 7, 14 and 20
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
Time frame: baseline to days 7, 14 and 20
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.
Contact information is provided by the study sponsor or research team.
Qualia Life Sciences
Industry
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07595705
Depigmentation, Gingival Pigmentation
Al Fayyum, Faiyum Governorate, Egypt
View Trial DetailsNCT07302828
Glutathione, Vitamin C
Taipei, Taiwan
View Trial DetailsNCT06896422
Bronchial Neoplasms, Carcinoma, Bronchogenic
Zhengzhou, Henan, China
View Trial DetailsNCT04105504
Glutathione, Skin Whitening
Jakarta Pusat, Indonesia
View Trial Details