Nicotinamide Adenine Dinucleotide Responses to a Nutritional Supplement

April 9, 2026 updated by: Shaklee Corporation

A Randomized, Controlled, Pilot Trial to Assess the Effects of a Proprietary Nutritional Supplement on Nicotinamide Adenine Dinucleotide (NAD+) Responses in Healthy Adults

The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+) in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The objective of this study is to evaluate nicotinamide adenine dinucleotide (NAD+), its metabolites, and markers of health in response to a proprietary nutritional supplement in generally healthy adults, compared to placebo.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Biofortis Research Clinical Director Biofortis Research Clinical Director
  • Phone Number: (630) 617-2000
  • Email: biofortisresearch@mxns.com

Study Locations

  • United States
    • Illinois
      • Addison, Illinois, United States, 60101
        • Recruiting
        • Biofortis Clinical Research
        • Contact:
        • Principal Investigator:
          • Aditi Shah

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Males and females, ≥45 to ≤65 years of age
  2. BMI ≥18.5 and <30.0 kg/m2
  3. Ambulatory and currently free of injury or other physical impairment that hinders mobility.
  4. Willing to use personal smart phone with operating system (Android version 12.0 or newer; iOS version 16 or newer).
  5. Willingness to maintain current skin care regimen and avoid any skin-related medical procedures.
  6. Willing to adhere to all study procedures, including lifestyle considerations and sign forms providing informed consent to participate in the study and authorization to release relevant protected health information to the Clinical Investigator.

Exclusion Criteria:

  1. Is currently following, or planning to be on, a weight loss regimen.
  2. Weight loss or gain >4.5 kg.
  3. History of gastrointestinal surgery for weight reducing purposes.
  4. History of an eating disorder (e.g., anorexia nervosa or bulimia nervosa, binge eating) at the discretion of the Clinical Investigator.
  5. History of neurologic disorder that could produce cognitive deterioration.
  6. History of bouts of delirium, confusion, repeated minor head injury or a single injury.
  7. History of unconventional sleep patterns or a diagnosed sleep disorder.
  8. History of any infective or inflammatory brain disease.
  9. Use of tobacco/nicotine products.
  10. Use of hemp/marijuana products.
  11. Unstable use of any prescription medication.
  12. Unstable use (initiation or change in dose) of hormonal contraceptives or therapy.
  13. Use of any dietary supplements (orally or infused), other than a conventional once daily multi-vitamin.
  14. Use of medication(s) or dietary supplement(s) known to affect absorption.
  15. Recent history of or strong potential for alcohol or substance abuse.
  16. Exposed to any non-registered drug product.
  17. A score of <7 on the Vein Access Scale Assessment.
  18. History or presence, on the basis of the medical history or screening labs, of clinically important cardiac, renal, hepatic, endocrine (including diabetes mellitus), pulmonary, gastrointestinal, biliary, pancreatic, or neurological disorders.
  19. Uncontrolled hypertension.
  20. Known allergy to any ingredients contained in the study product.
  21. Any signs or symptoms of active infection of clinical relevance.
  22. History or presence of cancer in the prior 2 years, except for non-melanoma skin cancer.
  23. History of any major trauma or major surgical event.
  24. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential with unstable use of sex hormones for contraception.
  25. An employee or representative who has a financial interest in Sponsor organization.

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: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Proprietary nutritional supplement
Participants will take the experimental supplement orally, daily.
Dietary supplement: Proprietary Nutritional Supplement
1000 mg nicotinamide metabolites and plant extracts, taken orally, daily for 60 days
Placebo Comparator: Placebo supplement
Participants will take the placebo supplement orally, daily.
Dietary supplement: Placebo Supplement
1000 mg maltodextrin, taken orally, daily for 60 days

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Nicotinamide adenine dinucleotide response in whole blood
Time Frame: Baseline to Day 14
Baseline to Day 14

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Nicotinamide adenine dinucleotide metabolite responses
Time Frame: Baseline to Days 1, 7, 14, and 30
Baseline to Days 1, 7, 14, and 30
Subjective cognitive function visual analog scales
Time Frame: Baseline to Days 30 and 60
Participants will rate how they feel on a horizontal line. Lines will be flanked with perceived feelings. Scores range from 0-100, where a higher score indicates increase in that feeling.
Baseline to Days 30 and 60
Subjective quality of life questionnaire
Time Frame: Baseline to Days 30 and 60
Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.
Baseline to Days 30 and 60
Metabolic health markers
Time Frame: Baseline to Days 30 and 60
Baseline to Days 30 and 60
Biological age
Time Frame: Baseline to Days 30 and 60
Baseline to Days 30 and 60
Cardiorespiratory fitness
Time Frame: Baseline to Day 30 and 60
Predicted VO2 max
Baseline to Day 30 and 60
Physical function
Time Frame: Baseline to Days 30 and 60
6 minute-walk test
Baseline to Days 30 and 60
Subjective skin assessment questionnaire
Time Frame: Days 30 and 60
Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling.
Days 30 and 60

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shaklee Corporation

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Biofortis Clinical Research, Inc.
Nlumn LLC

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Erin Barrett, PhD, Shaklee Corporation

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 17, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 2, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 13, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 9, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BIO-2601

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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