Effects of NAD3 Supplementation on Biomarkers of Aging
Effects of NAD3 Supplementation on Biomarkers of Anti-Aging in Healthy Men and Women
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ohio
-
Canfield, Ohio, United States, 44406
- The Center for Applied Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
EXPERIMENTAL: Active1
312 mg dose of active
|
NAD3 is an over-the-counter dietary supplement available online to consumers.
|
|
EXPERIMENTAL: Active2
812 mg dose of active
|
NAD3 is an over-the-counter dietary supplement available online to consumers.
|
|
PLACEBO_COMPARATOR: Placebo
placebo
|
NAD3 is an over-the-counter dietary supplement available online to consumers.
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
body weight
Time Frame: baseline
|
body weight in pounds
|
baseline
|
|
body weight
Time Frame: week 4
|
body weight in pounds
|
week 4
|
|
body weight
Time Frame: week 8
|
body weight in pounds
|
week 8
|
|
body weight
Time Frame: week 12
|
body weight in pounds
|
week 12
|
|
blood pressure
Time Frame: baseline
|
systolic and diastolic blood pressure in mm Hg
|
baseline
|
|
blood pressure
Time Frame: week 4
|
systolic and diastolic blood pressure in mm Hg
|
week 4
|
|
blood pressure
Time Frame: week 8
|
systolic and diastolic blood pressure in mm Hg
|
week 8
|
|
blood pressure
Time Frame: week 12
|
systolic and diastolic blood pressure in mm Hg
|
week 12
|
|
blood lipids
Time Frame: baseline
|
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
|
baseline
|
|
blood lipids
Time Frame: week 4
|
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
|
week 4
|
|
blood lipids
Time Frame: week 8
|
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
|
week 8
|
|
blood lipids
Time Frame: week 12
|
Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)
|
week 12
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
mood
Time Frame: baseline
|
subjective measurement of mood (number rating from Likert style scale questionnaire)
|
baseline
|
|
mood
Time Frame: week 4
|
subjective measurement of mood (number rating from Likert style scale questionnaire)
|
week 4
|
|
mood
Time Frame: week 8
|
subjective measurement of mood (number rating from Likert style scale questionnaire)
|
week 8
|
|
mood
Time Frame: week 12
|
subjective measurement of mood (number rating from Likert style scale questionnaire)
|
week 12
|
|
vitality
Time Frame: baseline
|
subjective measurement of vitality (number rating from Likert style scale questionnaire)
|
baseline
|
|
vitality
Time Frame: week 4
|
subjective measurement of vitality (number rating from Likert style scale questionnaire)
|
week 4
|
|
vitality
Time Frame: week 8
|
subjective measurement of vitality (number rating from Likert style scale questionnaire)
|
week 8
|
|
vitality
Time Frame: week 12
|
subjective measurement of vitality (number rating from Likert style scale questionnaire)
|
week 12
|
|
energy
Time Frame: baseline
|
subjective measurement of energy (number rating from Likert style scale questionnaire)
|
baseline
|
|
energy
Time Frame: week 4
|
subjective measurement of energy (number rating from Likert style scale questionnaire)
|
week 4
|
|
energy
Time Frame: week 8
|
subjective measurement of energy (number rating from Likert style scale questionnaire)
|
week 8
|
|
energy
Time Frame: week 12
|
subjective measurement of energy (number rating from Likert style scale questionnaire)
|
week 12
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (ACTUAL)
Study Start
Primary Completion (ACTUAL)
Primary Completion
Study Completion (ACTUAL)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (ACTUAL)
First Posted
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- CS-01-2020
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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