The Impact of Qualia Gluthathione+ on Blood Glutathione Levels

N/ANot Yet RecruitingNCT07221955

Qualia Life Sciences54 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

QUADRUPLE

Enrollment

Conditions

Effects of Qualia Glutathione+ on Blood Glutathione Levels Glutathione

Eligibility

Sex: ALLMin age: 45 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 0-20 days

Secondary Outcomes

between-group differences in blood Total Glutathione levels

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.

Time frame: baseline to day 20

within-group differences in the change in blood Glutathione levels

To assess within-group differences in the change in blood Glutathione levels

Time frame: baseline to day 20

Safety and Tolerability survey

To evaluate side effect profiles using a custom Safety and Tolerability survey.

Time frame: baseline to days 7, 14 and 20

PROMIS Global Health-10

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

Time frame: baseline to days 7, 14 and 20

PROMIS Short Form v1.0 - Fatigue 10a

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

Time frame: baseline to days 7, 14 and 20

PROMIS Cognitive Function - Short Form 8a

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

Time frame: baseline to days 7, 14 and 20

The Impact of Qualia Gluthathione+ on Blood Glutathione Levels

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts