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

August 13, 2025 updated by: Qualia Life Sciences

Comparison of Two Qualia NAD⁺ Formulations on Intracellular NAD⁺ Levels: A Randomized, Double-Blind, Placebo-Controlled Three-Arm Trial

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.

Study Overview

Study Type

Interventional

Enrollment (Estimated)

180

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Rice Flour
Active Comparator: Qualia NAD⁺ version 1
Qualia NAD+ version 1 manufactured by Qualia Life Sciences
Active Comparator: Qualia NAD⁺ version 2
Qualia NAD+ version 2 manufactured by Qualia Life Sciences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Between-group change in intracellular NAD⁺ levels
Time Frame: 28 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.
28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Aging-Related Symptoms (AMFS scores)
Time Frame: 4 weeks
To evaluate within-group and between-group differences in the change in Aging Male/Female Symptom (AMFS) total and sub-scale scores.
4 weeks
RAND SF-36 Scale Scores
Time Frame: 4 weeks
To assess within-group and between-group differences in RAND SF-36 domain scores.
4 weeks
Side effect profile as measured by a custom Safety and Tolerability survey
Time Frame: Week 1, 2, 3, and 4
To evaluate side effect profiles using a custom Safety and Tolerability survey.
Week 1, 2, 3, and 4
Within-group differences in the change in intracellular NAD⁺ levels
Time Frame: 4 weeks
To assess within-group differences in the change in intracellular NAD⁺ levels
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 13, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 15, 2025

Study Registration Dates

First Submitted

August 13, 2025

First Submitted That Met QC Criteria

August 13, 2025

First Posted (Actual)

August 20, 2025

Study Record Updates

Last Update Posted (Actual)

August 20, 2025

Last Update Submitted That Met QC Criteria

August 13, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • QLS-014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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