Effects of NAD3 Supplementation on Biomarkers of Aging

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

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).

Study Overview

• Status: Completed
• Conditions: Aging
• Intervention / Treatment: Dietary supplement: NAD3

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Canfield, Ohio, United States, 44406
      • The Center for Applied Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Active1; 312 mg dose of active	Dietary supplement: NAD3; NAD3 is an over-the-counter dietary supplement available online to consumers.
EXPERIMENTAL: Active2; 812 mg dose of active	Dietary supplement: NAD3; NAD3 is an over-the-counter dietary supplement available online to consumers.
PLACEBO_COMPARATOR: Placebo; placebo	Dietary supplement: NAD3; NAD3 is an over-the-counter dietary supplement available online to consumers.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Center for Applied Health Sciences, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 8, 2020
• Primary Completion (ACTUAL): January 29, 2021
• Study Completion (ACTUAL): May 30, 2021

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 18, 2020
• First Posted (ACTUAL): February 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 10, 2022
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: dietary supplement
• Other Study ID Numbers: CS-01-2020

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No