Clinical trial NCT04276948: Effects of NAD3 Supplementation on Biomarkers of Aging
Official title: Effects of NAD3 Supplementation on Biomarkers of Anti-Aging in Healthy Men and Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: dietary supplement
Lead sponsor: The Center for Applied Health Sciences, LLC
Sponsor class: INDUSTRY
First posted: 2020-02-19
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: body weight
timeFrame: baseline
measure: body weight
timeFrame: week 4
measure: body weight
timeFrame: week 8
measure: body weight
timeFrame: week 12
measure: blood pressure
timeFrame: baseline
measure: blood pressure
timeFrame: week 4
measure: blood pressure
timeFrame: week 8
measure: blood pressure
timeFrame: week 12
measure: blood lipids
timeFrame: baseline
measure: blood lipids
timeFrame: week 4
measure: blood lipids
timeFrame: week 8
measure: blood lipids
timeFrame: week 12
Secondary outcomes:
measure: mood
timeFrame: baseline
measure: mood
timeFrame: week 4
measure: mood
timeFrame: week 8
measure: mood
timeFrame: week 12
measure: vitality
timeFrame: baseline
measure: vitality
timeFrame: week 4
measure: vitality
timeFrame: week 8
measure: vitality
timeFrame: week 12
measure: energy
timeFrame: baseline
measure: energy
timeFrame: week 4
measure: energy
timeFrame: week 8
measure: energy
timeFrame: week 12
Other outcomes:
Locations:
city: Canfield
country: United States
facility: The Center for Applied Health Sciences
state: Ohio
Study officials:
References: