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Completed

NCT Number: NCT04276948

Effects of NAD3 Supplementation on Biomarkers of Aging

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).

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Key information

Conditions

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Center for Applied Health Sciences

Canfield, Ohio, 44406, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAD3

Dietary Supplement

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

Primary outcomes

  1. body weight

    Time frame: baseline

    body weight in pounds

  2. body weight

    Time frame: week 4

    body weight in pounds

  3. body weight

    Time frame: week 8

    body weight in pounds

  4. body weight

    Time frame: week 12

    body weight in pounds

  5. blood pressure

    Time frame: baseline

    systolic and diastolic blood pressure in mm Hg

  6. blood pressure

    Time frame: week 4

    systolic and diastolic blood pressure in mm Hg

  7. blood pressure

    Time frame: week 8

    systolic and diastolic blood pressure in mm Hg

  8. blood pressure

    Time frame: week 12

    systolic and diastolic blood pressure in mm Hg

  9. blood lipids

    Time frame: baseline

    Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)

  10. blood lipids

    Time frame: week 4

    Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)

  11. blood lipids

    Time frame: week 8

    Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)

  12. blood lipids

    Time frame: week 12

    Cholesterol profile (concentration of total cholesterol, HDL, LDL, TAG)

Secondary outcomes

  1. mood

    Time frame: baseline

    subjective measurement of mood (number rating from Likert style scale questionnaire)

  2. mood

    Time frame: week 4

    subjective measurement of mood (number rating from Likert style scale questionnaire)

  3. mood

    Time frame: week 8

    subjective measurement of mood (number rating from Likert style scale questionnaire)

  4. mood

    Time frame: week 12

    subjective measurement of mood (number rating from Likert style scale questionnaire)

  5. vitality

    Time frame: baseline

    subjective measurement of vitality (number rating from Likert style scale questionnaire)

  6. vitality

    Time frame: week 4

    subjective measurement of vitality (number rating from Likert style scale questionnaire)

  7. vitality

    Time frame: week 8

    subjective measurement of vitality (number rating from Likert style scale questionnaire)

  8. vitality

    Time frame: week 12

    subjective measurement of vitality (number rating from Likert style scale questionnaire)

  9. energy

    Time frame: baseline

    subjective measurement of energy (number rating from Likert style scale questionnaire)

  10. energy

    Time frame: week 4

    subjective measurement of energy (number rating from Likert style scale questionnaire)

  11. energy

    Time frame: week 8

    subjective measurement of energy (number rating from Likert style scale questionnaire)

  12. energy

    Time frame: week 12

    subjective measurement of energy (number rating from Likert style scale questionnaire)

Sponsors and collaborators

Lead sponsor

The Center for Applied Health Sciences, LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Feb 19, 2020
Registry last updated
Nov 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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