The Impact of Qualia Gluthathione+ on Blood Glutathione Levels

NCT ID: NCT07221955

Last Updated: 2025-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-02

Study Completion Date

2026-01-25

Brief Summary

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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.

Detailed Description

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Conditions

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Effects of Qualia Glutathione+ on Blood Glutathione Levels Glutathione

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Qualia Glutathione+ version 1

Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences

Group Type ACTIVE_COMPARATOR

Qualia Glutathione+ version 1

Intervention Type DIETARY_SUPPLEMENT

Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences

Qualia Glutathione+ version 2

Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences

Group Type ACTIVE_COMPARATOR

Qualia Glutathione+ version 2

Intervention Type DIETARY_SUPPLEMENT

Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences

Placebo

Rice flour placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Rice flour

Interventions

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Qualia Glutathione+ version 1

Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences

Intervention Type DIETARY_SUPPLEMENT

Qualia Glutathione+ version 2

Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences

Intervention Type DIETARY_SUPPLEMENT

Placebo

Rice flour

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Qualia Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Qualia Life Sciences

Carlsbad, California, United States

Site Status

Countries

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United States

Central Contacts

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William Scuba

Role: CONTACT

855-281-2328

Facility Contacts

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Study Coordinator

Role: primary

855-281-2328

Other Identifiers

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QLS-019

Identifier Type: -

Identifier Source: org_study_id

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