NCT07221955

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 24, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

October 29, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

December 2, 2025

Completed
20 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2026

Completed
Last Updated

November 14, 2025

Status Verified

November 1, 2025

Enrollment Period

20 days

First QC Date

October 24, 2025

Last Update Submit

November 12, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    0-20 days

Secondary Outcomes (6)

  • between-group differences in blood Total Glutathione levels

    baseline to day 20

  • within-group differences in the change in blood Glutathione levels

    baseline to day 20

  • Safety and Tolerability survey

    baseline to days 7, 14 and 20

  • PROMIS Global Health-10

    baseline to days 7, 14 and 20

  • PROMIS Short Form v1.0 - Fatigue 10a

    baseline to days 7, 14 and 20

  • +1 more secondary outcomes

Study Arms (3)

Qualia Glutathione+ version 1

ACTIVE COMPARATOR

Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences

Dietary Supplement: Qualia Glutathione+ version 1

Qualia Glutathione+ version 2

ACTIVE COMPARATOR

Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences

Dietary Supplement: Qualia Glutathione+ version 2

Placebo

PLACEBO COMPARATOR

Rice flour placebo

Dietary Supplement: Placebo

Interventions

Qualia Glutathione+ version 1 manufactured by Qualia Life Sciences

Qualia Glutathione+ version 1

Qualia Glutathione+ version 2 manufactured by Qualia Life Sciences

Qualia Glutathione+ version 2
PlaceboDIETARY_SUPPLEMENT

Rice flour

Placebo

Eligibility Criteria

Age45 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qualia Life Sciences

Carlsbad, California, 92011, United States

Location

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 24, 2025

First Posted

October 29, 2025

Study Start

December 2, 2025

Primary Completion

December 22, 2025

Study Completion

January 25, 2026

Last Updated

November 14, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations