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Not yet recruiting NCT07221955

The Impact of Qualia Gluthathione+ on Blood Glutathione Levels

No phase Interventional Effects of Qualia Glutathione+ on Blood Glutathione Levels Glutathione

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Qualia Glutathione+ version 1, Qualia Glutathione+ version 2, Placebo.
Who it may be relevant to
Registry conditions: Effects of Qualia Glutathione+ on Blood Glutathione Levels, Glutathione. Basic parameters: 45 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Dietary supplement Qualia Glutathione+ version 1
    Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences
  • Dietary supplement Qualia Glutathione+ version 2
    Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences
  • Dietary supplement Placebo
    Rice flour

Primary outcome measures

  • Total Glutathione levels from baseline to Day 20 [Time frame: 0-20 days]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Other

Study locations

United States · 1 center
  • Qualia Life Sciences — Carlsbad

Identifiers

NCT: NCT07221955 · QLS-019

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗