The Impact of Qualia Gluthathione+ on Blood Glutathione Levels
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-75
SponsorQualia Life Sciences
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Qualia Glutathione+ version 1
Dietary supplementQualia Glutathione+ version 1 manufactured by Qualia Life Sciences
Qualia Glutathione+ version 2
Dietary supplementQualia Glutathione+ version 2 manufactured by Qualia Life Sciences
Placebo
Dietary supplementRice flour
Treatment groups
54 Participants
are divided into 3 treatment groupsGroup A: Qualia Glutathione+ version 1Active comparator 1 intervention
Group B: Qualia Glutathione+ version 2Active comparator 1 intervention
Group C: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
0-20 daysSecondary outcomes
1
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.
Time frame
baseline to day 202
within-group differences in the change in blood Glutathione levels
To assess within-group differences in the change in blood Glutathione levels
Time frame
baseline to day 203
Safety and Tolerability survey
To evaluate side effect profiles using a custom Safety and Tolerability survey.
Time frame
baseline to days 7, 14 and 204
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. * Raw Score Minimum and Maximum: 0-20 * The higher the score, the better
Time frame
baseline to days 7, 14 and 20Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: