Effects of NAD3 Supplementation on Biomarkers of Aging

  • STATUS
    Recruiting
  • participants needed
    54
  • sponsor
    The Center for Applied Health Sciences, LLC
Updated on 19 February 2024
body mass index
systolic blood pressure
fatigue

Summary

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).

Details
Condition Senility
Age 40-60 years
Treatment NAD3
Clinical Study IdentifierNCT04276948
SponsorThe Center for Applied Health Sciences, LLC
Last Modified on19 February 2024

Eligibility

Yes No Not Sure

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
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