Effects of NAD3 Supplementation on Biomarkers of Aging

NCT04276948 | Completed DMC

• 1 other identifier: CS-01-2020
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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

Keywords

dietary supplement

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (12)

• mood

  baseline

• mood

  week 4

• mood

  week 8

• mood

  week 12

• vitality

  baseline

Study Arms (3)

Active1

EXPERIMENTAL

312 mg dose of active

Dietary Supplement: NAD3

Active2

EXPERIMENTAL

812 mg dose of active

Dietary Supplement: NAD3

Placebo

PLACEBO COMPARATOR

placebo

Dietary Supplement: NAD3

Interventions

NAD3 DIETARY_SUPPLEMENT

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

Active1; Active2; Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Center for Applied Health Sciences, LLC: lead

Study Sites (1)

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 17, 2020
• First Posted: February 19, 2020
• Study Start: June 8, 2020
• Primary Completion: January 29, 2021
• Study Completion: May 30, 2021
• Last Updated: November 14, 2022

Record last verified: 2020-02

Locations

US (1)