Effects of NAD3 Supplementation on Biomarkers of Aging

Study Overview
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Brief Summary
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This is a randomized, parallel-group, placebo-controlled, clinical trial in middle-aged and older male and female subjects from Ohio. Subjects will take an over-the-counter dietary supplement or a placebo for 12 weeks. Outcome measures will include body weight, systolic and diastolic blood pressure, standard blood chemistries (e.g. chemistry panel, lipid panel, CBC with differential), changes in mood, vitality, energy, fatigue, productivity, digestive wellness (via anchored Visual Analogue Scales).

Official Title
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Effects of NAD3 Supplementation on Biomarkers of Anti-Aging in Healthy Men and Women

Conditions
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Aging

Intervention / Treatment
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* Dietary Supplement: NAD3


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Provide voluntary signed and dated informed consent. Be in good health as determined by medical history, physical, and routine blood chemistries. Age between the ages of 40 and 60 (inclusive). Body Mass Index (BMI) of 18.5-34.9 kg/m2 (normal to Class I obesity). Normotensive (supine, resting systolic blood pressure <140 mm Hg and diastolic blood pressure < 90 mm Hg. If the first measurement is slightly elevated above these limits, the subject will be given a brief (5 minute) rest period, and two more measurements will be taken. The average of all three measurements will be used to determine eligibility. Normal supine, resting heart rate (<90 per minute). Willing to duplicate their previous 24-hour diet, and fast for 10 hours prior each of the treatments. Exclusion Criteria: History of uncontrolled diabetes. Regular use/consumption (i.e. at least 5 days/week) of resveratrol, quercetin, pterostilbene coQ10, grapefruit, nicotinamide riboside, probiotics, prebiotic fiber, green tea, niacin (vitamin B3), multivitamin/multimineral or products meant to promote healthy aging or anti-aging or longevity products in the 2 weeks prior to screening as well as throughout the study. Clinically significant abnormal blood work at screening. Consumption of > 2 alcoholic drinks per day. History of malignancy in the previous 5 years except for non-melanoma skin cancer (basal cell cancer or squamous cell cancer of the skin). Other known gastrointestinal or metabolic diseases that might impact nutrient absorption or metabolism, e.g. short bowel syndrome, diarrheal illnesses, history of colon resection, gastro paresis, Inborn-Errors-of-Metabolism (such as PKU). Chronic inflammatory condition/disease or unstable medical condition (e.g. rheumatoid arthritis, Crohn's disease, ulcerative colitis, Lupus, hepatitis, HIV/AIDS, etc.). Known sensitivity to any ingredient in the test formulations as listed in the Certificates-of-Analysis. Currently participating in another research study with an investigational product or have been in another research study in the past 30 days. History of drug or alcohol addiction or abuse within 1 year prior to screening. Treatment with any known enzyme-altering drugs such as barbiturates, glucocorticoids, macrolides, antidepressants, neuroleptics, imidazoles, or fluoroquinolones within 30 days prior to screening. Subjects who (for whatever reason) have been on a self-restricted diet, controlled diet or special therapeutic diet, or who have had substantial changes in eating habits within 30 days prior to screening. Donation of blood within 30 days or plasma within 7 days, prior to screening. History or presence of clinically significant diseases or conditions (e.g., cardiovascular, pulmonary, respiratory, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic, neurological, or psychiatric) which, in the opinion of the medical staff, could confound the primary endpoints or place the subject at increased risk of harm if they were to participate.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active1<br>312 mg dose of active | Dietary Supplement: NAD3<br>* NAD3 is an over-the-counter dietary supplement available online to consumers.<br>|
| Experimental: Active2<br>812 mg dose of active | Dietary Supplement: NAD3<br>* NAD3 is an over-the-counter dietary supplement available online to consumers.<br>|
| Placebo Comparator: Placebo<br>placebo | Dietary Supplement: NAD3<br>* NAD3 is an over-the-counter dietary supplement available online to consumers.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight | body weight in pounds | baseline | 
| body weight | body weight in pounds | week 4 | 
| body weight | body weight in pounds | week 8 | 
| body weight | body weight in pounds | week 12 | 
| blood pressure | systolic and diastolic blood pressure in mm Hg | baseline | 
| blood pressure | systolic and diastolic blood pressure in mm Hg | week 4 | 
| blood pressure | systolic and diastolic blood pressure in mm Hg | week 8 | 
| blood pressure | systolic and diastolic blood pressure in mm Hg | week 12 | 
| blood lipids | Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG) | baseline | 
| blood lipids | Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG) | week 4 | 
| blood lipids | Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG) | week 8 | 
| blood lipids | Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG) | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mood | subjective measurement of mood (number rating from Likert style scale questionnaire) | baseline | 
| mood | subjective measurement of mood (number rating from Likert style scale questionnaire) | week 4 | 
| mood | subjective measurement of mood (number rating from Likert style scale questionnaire) | week 8 | 
| mood | subjective measurement of mood (number rating from Likert style scale questionnaire) | week 12 | 
| vitality | subjective measurement of vitality (number rating from Likert style scale questionnaire) | baseline | 
| vitality | subjective measurement of vitality (number rating from Likert style scale questionnaire) | week 4 | 
| vitality | subjective measurement of vitality (number rating from Likert style scale questionnaire) | week 8 | 
| vitality | subjective measurement of vitality (number rating from Likert style scale questionnaire) | week 12 | 
| energy | subjective measurement of energy (number rating from Likert style scale questionnaire) | baseline | 
| energy | subjective measurement of energy (number rating from Likert style scale questionnaire) | week 4 | 
| energy | subjective measurement of energy (number rating from Likert style scale questionnaire) | week 8 | 
| energy | subjective measurement of energy (number rating from Likert style scale questionnaire) | week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dietary supplement