Effects of Qualia Glutathione+ on Blood Glutathione LevelsNCT07221955
The Impact of Qualia Gluthathione+ on Blood Glutathione Levels
A study testing Qualia Glutathione+ version 1 and Qualia Glutathione+ version 2 in people with Effects of Qualia Glutathione+ on Blood Glutathione Levels and Glutathione, run by Qualia Life Sciences at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Effects of Qualia Glutathione+ on Blood Glutathione Levels, Glutathione
- What is being tested?
- Qualia Glutathione+ version 1 and Qualia Glutathione+ version 2
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2025to 8 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Adults lacking capacity to consent
- Active Smokers
- Diagnosed Diabetics
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
- Being tested
- Qualia Glutathione+ version 1, Qualia Glutathione+ version 2, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualia Glutathione+ version 1Dietary supplement
Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences
Qualia Glutathione+ version 2Dietary supplement
Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences
PlaceboDietary supplement
Rice flour
| Study group | Role | What they receive |
|---|---|---|
| Qualia Glutathione+ version 1 | Active comparator | Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences Receives: Dietary Supplement: Qualia Glutathione+ version 1 |
| Qualia Glutathione+ version 2 | Active comparator | Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences Receives: Dietary Supplement: Qualia Glutathione+ version 2 |
| Placebo | Placebo comparator | Rice flour placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 0-20 days
Secondary outcomes (6)
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.
Measured: baseline to day 20
within-group differences in the change in blood Glutathione levels
To assess within-group differences in the change in blood Glutathione levels
Measured: baseline to day 20
Safety and Tolerability survey
To evaluate side effect profiles using a custom Safety and Tolerability survey.
Measured: 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.
- Raw Score Minimum and Maximum: 0-20
- The higher the score, the better
Measured: 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
Measured: 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
Measured: baseline to days 7, 14 and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2025
- Study start30 Nov 2025
- Primary completion22 Dec 2025
- Study completion8 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effects of Qualia Glutathione+ on Blood Glutathione LevelsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qualia Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221955
- Sponsor's protocol ID
- QLS-019
- Status last verified
- Oct 2026
- First submitted
- 24 Oct 2025
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Qualia Gluthathione+ on Blood Glutathione Levels
- ClinicalTrials.gov ID
- NCT07221955
- Acronym / sponsor ID
- QLS-019
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Qualia Life SciencesIndustry (pharma, biotech, devices)
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 22 Dec 2025 (actual)
- Study completion
- 8 Jan 2026 (actual)
- First posted
- 29 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Note on allocation (added September 2026): Participants were assigned to study arms by systematic allocation rather than by random allocation. Earlier versions of this record described the design as randomized. The Allocation field and the design descriptions were corrected to Non-Randomized to reflect the method actually used. No other aspect of the study design, conduct, or analysis changed.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Qualia Glutathione+ version 1 | Active comparator | Dietary Supplement: Qualia Glutathione+ version 1Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences |
| Qualia Glutathione+ version 2 | Active comparator | Dietary Supplement: Qualia Glutathione+ version 2Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboRice flour placebo |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Qualia Glutathione+ version 1Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences | Dietary supplement | Qualia Glutathione+ version 1 |
| Qualia Glutathione+ version 2Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences | Dietary supplement | Qualia Glutathione+ version 2 |
| PlaceboRice flour | Dietary supplement | Placebo |
Primary outcome
Total Glutathione levels from baseline to Day 20
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
6 secondary outcomes
between-group differences in blood Total Glutathione levels
Time frame: baseline to day 20
within-group differences in the change in blood Glutathione levels
Time frame: baseline to day 20
Safety and Tolerability survey
Time frame: baseline to days 7, 14 and 20
PROMIS Global Health-10
Time frame: baseline to days 7, 14 and 20
PROMIS Short Form v1.0 - Fatigue 10a
Time frame: baseline to days 7, 14 and 20
PROMIS Cognitive Function - Short Form 8a
Time frame: baseline to days 7, 14 and 20
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qualia Glutathione+ version 1 and Qualia Glutathione+ version 2 in people with Effects of Qualia Glutathione+ on Blood Glutathione Levels and Glutathione, run by Qualia Life Sciences at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Glutathione levels from baseline to Day 20 (time frame: 0-20 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.