- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07132801
- Original Trial
Comparison of Two Qualia NAD⁺ Formulations on Intracellular NAD⁺ Levels
Comparison of Two Qualia NAD⁺ Formulations on Intracellular NAD⁺ Levels: A Randomized, Double-Blind, Placebo-Controlled Three-Arm Trial
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: William Scuba
- Phone Number: 855-281-2328
- Email: support@qualialife.com
Study Locations
-
-
California
-
Carlsbad, California, United States, 92011
- Qualia Life Sciences
-
Contact:
- Abhi Ardagh
- Phone Number: 855-281-2328
- Email: support@qualialife.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- QLS-014
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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