Healthy Adult
Conditions
Keywords
NAD+ metabolism, Markers of health
Brief summary
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.
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.
Interventions
DIETARY_SUPPLEMENTProprietary Nutritional Supplement
1000 mg nicotinamide metabolites and plant extracts, taken orally, daily for 60 days
DIETARY_SUPPLEMENTPlacebo Supplement
1000 mg maltodextrin, taken orally, daily for 60 days
Sponsors
Shaklee Corporation
Biofortis Clinical Research, Inc.
Nlumn LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
45 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Nicotinamide adenine dinucleotide response in whole blood | Baseline to Day 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Nicotinamide adenine dinucleotide metabolite responses | Baseline to Days 1, 7, 14, and 30 | — |
| Subjective cognitive function visual analog scales | 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. |
| Subjective quality of life questionnaire | 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. |
| Metabolic health markers | Baseline to Days 30 and 60 | — |
| Biological age | Baseline to Days 30 and 60 | — |
| Cardiorespiratory fitness | Baseline to Day 30 and 60 | Predicted VO2 max |
| Physical function | Baseline to Days 30 and 60 | 6 minute-walk test |
| Subjective skin assessment questionnaire | Days 30 and 60 | Participants will rate how they feel on a Likert scale, where a higher score indicates increase in that feeling. |
Countries
United States
Contacts
STUDY_DIRECTORErin Barrett, PhD
Shaklee Corporation
Outcome results
None listed