Nicotinamide Adenine Dinucleotide Responses to a Nutritional Supplement

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: Recruiting
• Conditions: Healthy Adult
• Intervention / Treatment: Dietary supplement: Proprietary Nutritional Supplement; Dietary supplement: Placebo Supplement

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: Interventional
• Enrollment (Estimated): 34
• Phase: Not Applicable

Contacts and Locations

• Study Contact: 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: Biofortis Research Clinical Director; Email: biofortisresearch@mxns.com
      • Principal Investigator: Aditi Shah

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Nicotinamide adenine dinucleotide response in whole blood	Baseline to Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Nicotinamide adenine dinucleotide metabolite responses		Baseline to Days 1, 7, 14, and 30
Subjective cognitive function visual analog scales	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	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		Baseline to Days 30 and 60
Biological age		Baseline to Days 30 and 60
Cardiorespiratory fitness	Predicted VO2 max	Baseline to Day 30 and 60
Physical function	6 minute-walk test	Baseline to Days 30 and 60
Subjective skin assessment questionnaire	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

• Sponsor: Shaklee Corporation
• Collaborators: Biofortis Clinical Research, Inc.; Nlumn LLC
• Investigators: Study Director: Erin Barrett, PhD, Shaklee Corporation

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2026
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: February 2, 2026
• First Submitted That Met QC Criteria: February 17, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: NAD+ metabolism; Markers of health
• Other Study ID 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