The Impact of Qualia Gluthathione+ on Blood Glutathione Levels

Qualia Life Sciences

Status: Not yet enrolling

Conditions: Effects of Qualia Glutathione+ on Blood Glutathione Levels; Glutathione

Treatments: Dietary Supplement: Qualia Glutathione+ version 2; Dietary Supplement: Placebo; Dietary Supplement: Qualia Glutathione+ version 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT07221955

QLS-019

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 45 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 3 patient groups, including a placebo group

Qualia Glutathione+ version 1

Active Comparator group

Description:

Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences

Treatment:

Dietary Supplement: Qualia Glutathione+ version 1

Qualia Glutathione+ version 2

Active Comparator group

Description:

Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences

Treatment:

Dietary Supplement: Qualia Glutathione+ version 2

Placebo

Placebo Comparator group

Description:

Rice flour placebo

Treatment:

Dietary Supplement: Placebo