Effects of NAD3 Supplementation on Biomarkers of Aging

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04276948
• Other study ID #: CS-01-2020
• Status: Completed
• Phase: N/A
• Start date: June 8, 2020
• Est. completion date: May 30, 2021

Study information

• Verified date: February 2020
• Source: The Center for Applied Health Sciences, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: May 30, 2021
• Est. primary completion date: January 29, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Aging

Intervention

Dietary Supplement:
• NAD3
NAD3 is an over-the-counter dietary supplement available online to consumers.

Locations

Country	Name	City	State
United States	The Center for Applied Health Sciences	Canfield	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Center for Applied Health Sciences, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	body weight	body weight in pounds	baseline
Primary	body weight	body weight in pounds	week 4
Primary	body weight	body weight in pounds	week 8
Primary	body weight	body weight in pounds	week 12
Primary	blood pressure	systolic and diastolic blood pressure in mm Hg	baseline
Primary	blood pressure	systolic and diastolic blood pressure in mm Hg	week 4
Primary	blood pressure	systolic and diastolic blood pressure in mm Hg	week 8
Primary	blood pressure	systolic and diastolic blood pressure in mm Hg	week 12
Primary	blood lipids	Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)	baseline
Primary	blood lipids	Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)	week 4
Primary	blood lipids	Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)	week 8
Primary	blood lipids	Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)	week 12
Secondary	mood	subjective measurement of mood (number rating from Likert style scale questionnaire)	baseline
Secondary	mood	subjective measurement of mood (number rating from Likert style scale questionnaire)	week 4
Secondary	mood	subjective measurement of mood (number rating from Likert style scale questionnaire)	week 8
Secondary	mood	subjective measurement of mood (number rating from Likert style scale questionnaire)	week 12
Secondary	vitality	subjective measurement of vitality (number rating from Likert style scale questionnaire)	baseline
Secondary	vitality	subjective measurement of vitality (number rating from Likert style scale questionnaire)	week 4
Secondary	vitality	subjective measurement of vitality (number rating from Likert style scale questionnaire)	week 8
Secondary	vitality	subjective measurement of vitality (number rating from Likert style scale questionnaire)	week 12
Secondary	energy	subjective measurement of energy (number rating from Likert style scale questionnaire)	baseline
Secondary	energy	subjective measurement of energy (number rating from Likert style scale questionnaire)	week 4
Secondary	energy	subjective measurement of energy (number rating from Likert style scale questionnaire)	week 8
Secondary	energy	subjective measurement of energy (number rating from Likert style scale questionnaire)	week 12