The Impact of Qualia Gluthathione+ on Blood Glutathione Levels

November 12, 2025 updated by: Qualia Life Sciences
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Qualia Glutathione+ version 1
Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences
Dietary supplement: Qualia Glutathione+ version 1
Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences
Active Comparator: Qualia Glutathione+ version 2
Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences
Dietary supplement: Qualia Glutathione+ version 2
Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences
Placebo Comparator: Placebo
Rice flour placebo
Dietary supplement: Placebo
Rice flour

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0-20 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
between-group differences in blood Total Glutathione levels
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.
baseline to day 20
within-group differences in the change in blood Glutathione levels
Time Frame: baseline to day 20
To assess within-group differences in the change in blood Glutathione levels
baseline to day 20
Safety and Tolerability survey
Time Frame: baseline to days 7, 14 and 20
To evaluate side effect profiles using a custom Safety and Tolerability survey.
baseline to days 7, 14 and 20
PROMIS Global Health-10
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.

  • Raw Score Minimum and Maximum: 0-20
  • The higher the score, the better
baseline to days 7, 14 and 20
PROMIS Short Form v1.0 - Fatigue 10a
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
baseline to days 7, 14 and 20
PROMIS Cognitive Function - Short Form 8a
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.

- Raw Score Minimum and Maximum: 8-40 - The higher the score, the better
baseline to days 7, 14 and 20

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qualia Life Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 2, 2025

Primary Completion (Estimated)

December 22, 2025

Study Completion (Estimated)

January 25, 2026

Study Registration Dates

First Submitted

October 24, 2025

First Submitted That Met QC Criteria

October 24, 2025

First Posted (Estimated)

October 29, 2025

Study Record Updates

Last Update Posted (Estimated)

November 14, 2025

Last Update Submitted That Met QC Criteria

November 12, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • QLS-019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glutathione

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe