Study

NAD Biomarker Study

Protocol: LBL-1001

IRB: OHRP#: 0001099

Purpose of this Study

This is an IRB approved study with the purpose of obtaining information on the effectiveness of different collection and preparation methods for measuring NAD biomarkers.

Benefits

Possible benefits to you include learning your levels of up to five different NAD metabolites (including NAD+), the possibility to learn more about how any NAD boosting protocol you may engage in is affecting your NAD metabolite levels.

How signing up for this study works:

  1. Make sure you meet the Inclusion Criteria and do not meet the Exclusion Criteria. You can find the inclusion and exclusion criteria below.

  2. Decide if you want to work with your or practitioner or clinician or would like us to recommend one to you.


    Note: Your practitioner or clinician (or their phlebotomist) must have a 4°C refrigerated centrifuge to be able to process your sample. We are happy to confirm this if you provide the name and contact information of your practitioner.

  3. In consultation with your practitioner or clinician, decide if you prefer to participate with 1 test or 3 tests. 1 test will measure NAD levels at a point in time. 3 tests may be used to measure a boosting protocol for baseline, post-boost, and decay. 3 tests can also measure baseline and 2 different quantities of an ongoing boosting treatment.

  4. When you start the process of enrolling you will be asked to choose your level of participation and fund as indicated on the Participation Options page.

  5. We will send the appropriate study collection kits to your practitioner or clinician.

  6. Your practitioner or clinician will review the Informed Consent with you, which is a document required by the FDA to participate in the research that ensures you understand the study and voluntarily agree to participate.

  7. You will coordinate any boosting protocols and timing of sample collections with the practitioner who is guiding your participation in the study, and arrange with them for the collection of your samples. We will confirm with your practitioner or clinician in advance their arrangements for the processing, storage and shipping of the samples to the lab.

    Note: Because this is a self-directed study and you are free to do any collection and boosting protocols you choose with any licensed practitioner or clinician who has the required collection equipment, you will be responsible for the costs of practitioner consultations and phlebotomy services, shipping of samples to our study lab by your practitioner, and any boosting treatments you engage in.


    The shipping of samples to the lab is not included in the participation cost because some practitioners may be shipping multiple samples at a time, which will significantly reduce the per sample shipping cost.

  8. The absolute values of NAD metabolites will be reported to you. We will make every effort to return metabolite values as quickly as possible, however because this is a research study that will require sample aggregation and batch processing before reporting of results, the reporting of results may take more time than a typical commercial test.

Inclusion Criteria

In order to participate in this study, you must be:

    • Male or Female age 18 or older;
    • Willing and able to consent to this study;
    • Working with a licensed practitioner or clinician that can guide your participation and determine that you do not meet any of the exclusion criteria;
    • Able to read and understand English; and
    • Have the ability to facilitate the sample collection from a person licensed to do so.

Exclusion Criteria

You may not participate in this study if:

    • You would be considered a vulnerable subject, including being: less than 18 years old, pregnant, a nursing home resident or other institutionalized person, a prisoner, unable to read and understand English, or a person with decisional incapacity. (Students, employees of the study sponsor or site, and individuals who are physically disabled but mentally able to consent may be included);
    • You have any incapacitation that makes you unable to consent;
    • You are known or suspected to be infected with a Level 3 or Level 4 biohazard as determined by your licensed practitioner or clinician, or otherwise have a serious or life-threatening illness; and
    • In the opinion of the Investigator or your licensed practitioner or clinician, you may be non-compliant with study schedules or procedures.

Risks and Discomforts

Risks of venipuncture (standard blood draw) and /or finger pricking are generally low. There is a small risk of some pain and bruising. Vasovagal reactions, phlebitis and nerve injuries are extremely rare.

All blood collection procedures will be conducted under the direction of your licensed practitioner or clinician, and any action intended to minimize or address a reaction to the procedure will be according to the direction of your licensed practitioner or clinician.

Study Procedures

Your participation will occur at the location of a licensed practitioner or clinician. You will be permitted to ask any questions you have before consenting. You will review any decision to participate in this research with your practitioner, decide how many tests you would like to perform, and what if any protocols you would like to coordinate to your test sample collections.

You will fund the test collection for either 1 or 3 tests, and the collection kit(s) will be sent to you or your practitioner accordingly. You will have blood samples collected by venipuncture and blood spot card by the practitioner or phlebotomist and fill out a questionnaire asking about your recent NAD boosting protocol history. The questionnaire will be approximately 1 page and require less than 10 minutes to complete. The venipuncture blood draw will total between 10mL to 20 mL (1 or 2 regular tubes), and the finger stick draw will total approximately 60 µL (2 drops).

This study does not require any interventions or protocols. The times and dates of any sample collection, any NAD boosting protocols you may or may not engage in, and the number of times samples are collected are entirely up to you under the guidance of your practitioner or clinician. You will not need to partake in or refrain from any activity for the purposes of this research.

Cost to Participate

Taking part in this research will cost a per-test charge that includes the cost of the sample collection kit, shipping of the kit to you, the performance of the tests on your samples in the laboratory, providing the test results to you, and the facilitation of your participation in the research study. The cost for 1 sample collection participation is $280.44. The cost for 3 sample collection participation is $794.59.

Additional costs to you that are not included in the per-test charge include the collection of your samples by someone licensed to perform phlebotomy services, shipping of collected samples to the lab as required, any consultation or engagement of your practitioner or clinician, and the costs of any NAD boosting protocol you may wish to engage in.

Alternative Treatments

This research is not intended to diagnose, treat, cure or prevent any disease, and no clinically relevant results or medical inference will be provided to participants. Your alternative is to not take part in the research.

Information

If you have questions or concerns, please contact us at (844)623-7587. You can also email us at study@nadtreatmentcenter.com.

If you have any questions about your rights as a research subject, you may call the ARGUS Independent Review Board Chairman at (520) 298-7494. ARGUS IRB is an ethics committee that is established to help protect the rights and welfare of study subjects.