CompletedEarly Phase 1

Renewal-NAD+: A Study of Oral NAD+ and Its Multi-omic Impact in a Healthy Cohort

United States60 participantsStarted 2022-02-23

Plain-language summary

The goal of this 5 day interventional study was to investigate the effects on multiple biological molecules (multi-omics) of Bryleos's commercially available oral LathMized™ Nicotinamide adenine dinucleotide (LNAD+) supplement in healthy adults aged 45-75 years. The main question to be answered was whether LNAD+ supplementation is associated with change in biological markers relevant to subjects' health. Also, the study determined whether this oral NAD+ formulation raised NAD+ levels including inside blood cells, after the 5 day treatment period, measured on post-treatment Day 1 (Day 6). Thus, the study compared NAD+ levels and impact on biological markers in the LNAD+ arm versus control placebo arm. Safety in this population was assessed using clinical laboratory tests, daily self-reporting of symptoms, and data from a wearable device.

Who can participate

Age range45 Years – 75 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: English-speaking adults in the age range between 45 and 75 years in overall self-reported good health (excluding common conditions such as hypertension, and hyperlipidemia); * Participants able to consent for themselves; * Able to commit to the study protocol, including a 7-day washout of potentially confounding substances via restriction of supplement intake; * Tolerance for repeated venous blood draws, supplement administration, and assessment schedule, tolerance for wrist-worn wearable devices well (i.e., consistent use during the day as well as at night for the duration of the study). Exclusion Criteria: * Body Mass Index (BMI) \> 35 kg/m2; * Current chronic or acute infectious diseases (e.g., hepatitis, influenza, HIV, Lyme; COVID-19 within the past two months); * Recent SARS-CoV-2 vaccine administration (within two weeks); * Current use of NAD+ supplements and precursors; * Use of systemic anti-inflammatory medications (excluding NSAIDs and acetaminophen), immunosuppressants; * Current cancer or hematologic conditions and/or cancer treatment (radiation, chemotherapy); * Type I juvenile or Type 2 diabetes mellitus; * Autoimmune disorders (multiple sclerosis, lupus, rheumatoid arthritis, psoriasis); * Inflammatory bowel disease (ulcerative colitis, Crohn's disease); * Current pregnancy; * Current substance abuse, including alcohol, but excluding nicotine and prescription medications (e.g., physician-prescribed stimulants, opiates); * Members of the …

What they're measuring

Pharmacokinetics-NAD+ concentrations

Timeframe: From enrollment through seven day washout, 2 baseline measurements); treatment 5 days, measured on day 3 and one day post day 5 treatment (Day 6)]

Trial details

NCT IDNCT07336836

SponsorBioNADrx Holdings, Inc. Bryleos

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-04