Nutritional supplement effects on NAD+ levels in healthy middle-aged adults

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

This trial will test whether a proprietary nutritional supplement raises NAD+ and related health markers in generally healthy adults aged 45 to 65 compared with a placebo.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 45 Years to 65 Years
• Sex: All
• Sponsor: Shaklee Corporation (Industry-sponsored)
• Locations: 1 site (Addison, Illinois)
• Trial ID: NCT07428889 on ClinicalTrials.gov

What this trial studies

Generally healthy adults aged 45–65 with BMI 18.5–<30 will be enrolled and receive either a proprietary nutritional supplement or a matching placebo. Blood levels of NAD+, its metabolites, and selected markers of health will be measured before and after the intervention to compare responses between groups. Participants must be ambulatory, maintain their current skin care regimen, and use a compatible smartphone for study procedures. The study is conducted at Biofortis Clinical Research in Addison, Illinois.

Who should consider this trial

Good fit: Ideal candidates are generally healthy men and women aged 45–65 with BMI between 18.5 and 30, who are ambulatory, willing to use a compatible smartphone, and able to follow study lifestyle and skin-care restrictions.

Not a fit: People actively on a weight-loss program, with recent significant weight change, prior weight-loss surgery, or a history of eating disorders are unlikely to qualify or benefit from this study.

Why it matters

Potential benefit: If successful, the supplement could raise NAD+ levels and improve related metabolic or cellular health markers in middle-aged adults.

How similar studies have performed: Previous human studies of NAD+ precursors have shown that some supplements can increase NAD+ levels, but proprietary formulations vary so results are not guaranteed.

Eligibility criteria

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.

Where this trial is running

Addison, Illinois

• Biofortis Clinical Research — Addison, Illinois, United States (Recruiting)

Study contacts

• Study coordinator: Biofortis Research Clinical Director Biofortis Research Clinical Director

Conditions Healthy Adult; NAD+ metabolism; Markers of health