Effects of NAD3 Supplementation on Biomarkers of Aging

NCT ID: NCT04276948

Last Updated: 2022-11-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-08
• Study Completion Date: 2021-05-30

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).

Conditions

Aging

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Active1

312 mg dose of active

Group Type: EXPERIMENTAL

NAD3

Intervention Type: DIETARY_SUPPLEMENT

NAD3 is an over-the-counter dietary supplement available online to consumers.

Active2

812 mg dose of active

Group Type: EXPERIMENTAL

NAD3

Intervention Type: DIETARY_SUPPLEMENT

NAD3 is an over-the-counter dietary supplement available online to consumers.

Placebo

placebo

Group Type: PLACEBO_COMPARATOR

NAD3

Intervention Type: DIETARY_SUPPLEMENT

NAD3 is an over-the-counter dietary supplement available online to consumers.

Interventions

NAD3

NAD3 is an over-the-counter dietary supplement available online to consumers.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Center for Applied Health Sciences, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Center for Applied Health Sciences

Canfield, Ohio, United States

Countries

United States

Other Identifiers

CS-01-2020

Identifier Type: -

Identifier Source: org_study_id