MedPath

Comparison of Two Qualia NAD⁺ Formulations on Intracellular NAD⁺ Levels

Not Applicable
Not yet recruiting
Conditions
NAD
NAD+ Levels in the Blood
Registration Number
NCT07132801
Lead Sponsor
Qualia Life Sciences
Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group study evaluating the effects of two distinct Qualia NAD⁺ formulations on intracellular NAD⁺ levels in healthy adults aged 35-75 years. Approximately 180 participants will be randomized to one of three study arms: Qualia NAD⁺ version 1, Qualia NAD⁺ version 2, or placebo. Each participant will take two capsules of their assigned product once daily in the morning, with or without food, over a 28-day period. The primary outcome is the change in intracellular NAD⁺ levels, assessed via at-home finger-stick blood collection at baseline and study completion. Secondary endpoints include changes in aging-related symptoms (AMFS scores), health-related quality of life (RAND SF-36), and evaluation of safety and tolerability. All assessments, including electronic questionnaires, are completed remotely without in-person visits.

Detailed Description

Not available

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
180
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 35-75 years Willing to self-administer the intracellular NAD⁺ finger-stick test at home (baseline and Day 28) Willing to avoid supplements, energy drinks/shots, or other products containing niacin, niacinamide, nicotinamide riboside, or NMN for ≥ 2 weeks before baseline and 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 Individuals who were deemed incompatible with the test protocol Adults lacking capacity to consent

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Between-group change in intracellular NAD⁺ levels28 days

To assess between-group differences in the change in intracellular NAD⁺ levels from baseline to Week 4 following supplementation with Qualia NAD version 1, Qualia NAD version 2, or placebo.

Secondary Outcome Measures
NameTimeMethod
Aging-Related Symptoms (AMFS scores)4 weeks

To evaluate within-group and between-group differences in the change in Aging Male/Female Symptom (AMFS) total and sub-scale scores.

RAND SF-36 Scale Scores4 weeks

To assess within-group and between-group differences in RAND SF-36 domain scores.

Side effect profile as measured by a custom Safety and Tolerability surveyWeek 1, 2, 3, and 4

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

Within-group differences in the change in intracellular NAD⁺ levels4 weeks

To assess within-group differences in the change in intracellular NAD⁺ levels

Trial Locations

Locations (1)

Qualia Life Sciences

🇺🇸

Carlsbad, California, United States

Qualia Life Sciences
🇺🇸Carlsbad, California, United States
Abhi Ardagh
Contact
855-281-2328
support@qualialife.com

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