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

NCT07336836 | Completed Early Phase 1

• 1 other identifier: 1320748
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Participants; Health Adult Subjects

Keywords

NAD+, dietary supplement

Outcome Measures

Primary Outcomes (1)

• Pharmacokinetics-NAD+ concentrations

  All primary endpoint NAD+ measurements were performed by a CLIA-certified laboratory (Augusta, GA, USA). The proprietary validated enzymatic assay quantifies total NAD (NAD+ plus NADH) in both intracellular (icNAD) and circulating (cirNAD) compartments. The assay specifically quantifies total NAD, reflecting technical considerations and the current state of clinical validation for NAD+/NADH ratio measurements. For most clinical applications, including assessment of supplementation efficacy, total NAD levels can be considered the primary actionable biomarker.

  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)]

Secondary Outcomes (13)

• Pharmacodynamic Endpoints: Metabolic Fate

  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)

• Pharmacodynamic Endpoints:Liver Function

  From enrollment through seven day washout, (2 baseline measurements); treatment 5 days, measured on day 3 and none day post day 5 treatment (Day6)]

• Pharmacodynamic Endpoints: Oxidative Stress

  From enrollment through seven day washout, (2 baseline measurements); treatment 5 days, measured on day 3 and none day post day 5 treatment (Day6)]

• Pharmacodynamic Endpoints: Glucose Metabolism

  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)]

• Pharmacodynamic Endpoints: Lipid Metabolism

  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)

Other Outcomes (1)

• Exploratory Biological Molecules (Multi-omics)

  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)]

Study Arms (2)

Treatment arm

EXPERIMENTAL

LNAD+ (50%)/PEG (50%) treatment total 500 mg

Dietary Supplement: LathMized TM NAD+ (LNAD+)

Control arm

PLACEBO COMPARATOR

PEG 500 mg

Other: Control (placebo)

Interventions

LathMized TM NAD+ (LNAD+) DIETARY_SUPPLEMENT

NAD+ 500 mg

Treatment arm

Control (placebo) OTHER

PEG (100% of mass)

Control arm

Eligibility Criteria

• Age: 45 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 same household.

Sponsors & Collaborators

• BioNADrx Holdings, Inc. Bryleos: lead
• ISB Analytica, LLC: collaborator

Study Sites (1)

ISB Bioanalytica, Inc.

Seattle, Washington, 98109, United States

Location

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was double blinded, all investigators, study personnel, molecular facilities and participants were naive to treatment identity.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized placebo-controlled

Study Record Dates

• First Submitted: December 19, 2025
• First Posted: January 13, 2026
• Study Start: February 23, 2022
• Primary Completion: June 4, 2022
• Study Completion: June 4, 2022
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)