A Clinical Trial to Assess the Absorption, Safety, and Efficacy of an Oral Nicotinamide Adenine Dinucleotide (NAD+) Supplement in Healthy Adults

NCT07692633 | Not Yet Recruiting

• 1 other identifier: 25RRCRR01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the absorption, safety, and efficacy of an NAD+ supplement in healthy adults. The main question it aims to answer is: What is the change in NAD+ levels in whole blood from baseline to day 56 between the NAD+ supplement and placebo? Researchers will compare the NAD+ supplement to placebo to evaluate its absorption, safety, and efficacy. Participants will be asked to:

• Complete questionnaires
• Provide blood samples
• Consume either the NAD+ supplement or a placebo for 55 days
• Have their endothelial function evaluated

Conditions

NAD+ Safety; NAD+ Efficacy; NAD+ Bioavailability

Keywords

NAD+; Nicotinamide adenine dinucleotide

Outcome Measures

Primary Outcomes (1)

• Change in NAD+ levels in whole blood from baseline to day 56 between the NAD+ supplement and placebo.

  Change in NAD+ levels in whole blood from baseline to day 56 between the NAD+ supplement and placebo.

  Day 0 to 56

Secondary Outcomes (7)

• Change in NAD+ levels in whole blood from baseline to days 14 and 28 between the NAD+ supplement and placebo.

  Baseline to Days 14 and 28

• Change from baseline to days 28 and 56 between the NAD+ supplement and placebo in Cognitive function

  Baseline to Days 28 and 56

• Change from baseline to days 28 and 56 between the NAD+ supplement and placebo in appearance and aesthetics

  Baseline to days 28 and 56

• Change from baseline to day 56 between the NAD+ supplement and placebo in energy and metabolism

  Day 0 to 56

• Change from baseline to day 56 between the NAD+ supplement and placebo in cellular health and longevity

  Day 0 to 56

Other Outcomes (23)

• Incidence of post-emergent adverse events (AE)

  Screening (day -45 to day-15) to day 56

• Clinically relevant changes in blood pressure after supplementation

  Screening (day -45 to day -15) to day 56

• Clinically relevant changes in heart rate after supplementation

  Screening (day -45 to day -15) to day 56

Study Arms (2)

NAD+

EXPERIMENTAL

Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit.

Dietary Supplement: NAD+

Placebo

PLACEBO COMPARATOR

Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit.

Dietary Supplement: Placebo

Interventions

NAD+ DIETARY_SUPPLEMENT

Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit.

NAD+

Placebo DIETARY_SUPPLEMENT

Participants will be instructed to take two capsules daily after breakfast starting on Day 1 (day following baseline visit) until the day prior to their end of study visit.

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females between 40 and 65 years of age, inclusive, at screening
• Body Mass Index (BMI) between 18.5 and 29.9 kg/m2
• Females not of child-bearing potential, defined as those who have undergone a sterilization procedure (e.g. hysterectomy, bilateral oophorectomy, bilateral tubal ligation, complete endometrial ablation) or have been post-menopausal for at least 1 year prior to screening Or, Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:
• Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), or hormone implant (Norplant System)
• Double-barrier method
• Intrauterine devices
• Non-heterosexual lifestyle and agrees to use contraception if planning on changing to heterosexual partner(s)
• Vasectomy of partner at least 6 months prior to screening
• Abstinence and agrees to use contraception if planning on becoming sexually active during the study
• Willingness to complete questionnaires and diaries associated with the study and to complete all visits
• Agrees to maintain current lifestyle habits (physical activity, medications, supplements, and sleep) as much as possible throughout the study
• Agrees to follow the specified low NAD-precursor diet during the run-in period and throughout the study
• Agrees to avoid caffeine (e.g., tea, coffee, energy drinks) for 12 hours (h) prior to post-screening in-clinic study visits
• Agrees to avoid alcohol consumption and vigorous physical activity for 24 h prior to post-screening in-clinic study visits
• Provided voluntary, written, informed consent to participate in the study

You may not qualify if:

• Individuals who are pregnant, breast feeding, or planning to become pregnant during the study
• Allergy, sensitivity, intolerance, or dietary restriction preventing consumption of investigational product (test material's active or inactive ingredient) or placebo ingredients
• Unstable metabolic disease or chronic diseases as assessed by the QI
• Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI
• Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 1)
• Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis
• History of or current diagnosis with kidney and/or liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months
• Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI
• Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI
• Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable
• Individuals with an autoimmune disease or are immune compromised as assessed by the QI
• Self-reported confirmation of a human immunodeficiency virus (HIV)-, Hepatitis B- and/or C-positive diagnosis as assessed by the QI
• Self-reported confirmation of blood/bleeding disorders as assessed by the QI
• Use of medical cannabinoid products
• Chronic use of cannabinoid products (\>2 times/week). Occasional users will be required to washout and abstain for the duration of the study period

Sponsors & Collaborators

• Reus Research: lead
• KGK Science Inc.: collaborator

Study Sites (1)

KGK Science Inc.

London, Canada

Location

MeSH Terms

Interventions

NAD

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Central Study Contacts

Erin Lewis

CONTACT

+248 1-226-242-4551; elewis@kgkscience.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2026
• First Posted: July 9, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)