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

Short name Renewal-NAD+

NCTNCT07336836Other id1320748

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Early phase 1
Enrollment: 60 participants (actual)
Sponsor: BioNADrx Holdings, Inc. Bryleos · Industry
Design: Randomized · Quadruple masking
Countries: 1 country
United States
Start: 23 Feb 2022
Primary completion: 4 Jun 2022
Completion: 4 Jun 2022
First posted: 13 Jan 2026
Last update posted: 13 Jan 2026
Conditions: Health Adult Subjects · Healthy Participants

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20222023

Ph Early 1
Renewal-NAD+
NCT07336836
23 Feb 2022 to 4 Jun 2022

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

LathMized TM NAD+ (LNAD+)Dietary supplement
Control (placebo)Other

Arms2

Experimental
Treatment arm
LNAD+ (50%)/PEG (50%) treatment total 500 mg
Placebo comparator
Control arm
PEG 500 mg

Primary outcomes1

Outcomes the sponsor listed as primary.

Pharmacokinetics-NAD+ concentrations
Time frame · 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)]
Registry description
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.

Secondary outcomes(13)

Pharmacodynamic Endpoints: Metabolic Fate
Time frame · 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)
Registry description
Metabolic fate: plasma abundance of six NAD+ metabolites was assayed via Metabolon's Global Discovery Platform, including nicotinamide (NAM), methylated NAM (MeNAM), 2PY, nicotinate, trigonelline, and quinolinate. •
Pharmacodynamic Endpoints:Liver Function
Time frame · From enrollment through seven day washout, (2 baseline measurements); treatment 5 days, measured on day 3 and none day post day 5 treatment (Day6)]
Registry description
Serum alanine transaminase, aspartate transaminase, alkaline phosphatase, and total bilirubin
Pharmacodynamic Endpoints: Oxidative Stress
Time frame · From enrollment through seven day washout, (2 baseline measurements); treatment 5 days, measured on day 3 and none day post day 5 treatment (Day6)]
Registry description
Oxidative stress: gamma glutamyl transferase and cumulative reactive oxygen metabolites (ROM) were used as surrogate endpoints. Cumulative ROM included oxygen O2, superoxide anion O2-, peroxide O2-, hydrogen peroxide H2O2, hydroxyl radical OH, and hydroxyl ion OH-.
Pharmacodynamic Endpoints: Glucose Metabolism
Time frame · 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)]
Registry description
Glucose metabolism: fasting serum glucose.
Pharmacodynamic Endpoints: Lipid Metabolism
Time frame · 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)
Registry description
Lipid metabolism: serum triglycerides, LDL, HDL, and HDL/LDL ratio.
Pharmacodynamic Endpoints: Inflammation
Time frame · 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)]
Registry description
Inflammation: indexed by a combination of pro-inflammatory cytokines TNF, IL-6, and hs-CRP, as well complete blood count differentials.
Pharmacodynamic Endpoint: Kidney Function
Time frame · From enrollment through seven day washout, (2 baseline measurements); treatment 5 days, measured on day 3 and none day post day 5 treatment (Day6)]
Registry description
Kidney Function: serum creatinine, estimated glomerular filtration rate (eGFR) and blood urea nitrogen
Physical Safety Measures: Vitals
Time frame · From enrollment to end of treatment day 5 (measured post treatment Day 1(Day 6)]
Registry description
Vitals: Height and weight, BMI (kg/m3) were measured twice and averaged for each study blood draw / mobile phlebotomist visit. • :
Physical Safety Measures: Vitals
Time frame · Time Frame: From enrollment to end of treatment day 5 (measured post treatment Day 1 [Day6])
Registry description
Systolic and diastolic blood pressure (mm/Hg and resting heart rate (bpm) were measured twice and averaged for each study blood draw / mobile phlebotomist visit.
Physical Safety Measures: Adverse Events
Time frame · From enrollment to end of treatment day 5 (measured post treatment Day 1[Day6]
Registry description
Patient-reported adverse event incidence was tabulated at the end of the study
Physical Safety Measures: Physical Symptoms
Time frame · From enrollment to end of treatment day 5 (Measured post treatment day 5 [Day6])
Registry description
Daily self-reported physical symptom data across body and organ system
Physical Safety Measures: subjective measures of well-ing
Time frame · From enrollment to end of treatment day 5 (Measured post treatment day 5 [Day6])
Registry description
Administered self-report questionnaires including a daily version of Depression, Anxiety, and Stress Scale 21 or DASS-21, with appropriate modifications given the design of the study; Clinically Useful Anxiety Outcome Scale-Daily Version or CUXOS-D
Physical Safety Outcome Measures: Wearables Data
Time frame · From first day of study washout period to end of treatment day 5 (Measured post treatment day 5 [Day6])
Registry description
Wearable data were collected using Fitbit Luxe devices. Examined surrogate endpoints included indices of activity (steps) and sleep quality

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Other registry references

References listed at the registry that are not in PepBank. They link to PubMed.

DerivedKornilov SA, Hastings WJ, McGrath LF, Leitz-Langan M, Magis AT, Coppess SM, Komac W. Oral LNAD+ rapidly elevates whole blood intracellular NAD and metabolic flux without elevating plasma NAD: evidence from a randomized controlled trial. Geroscience. 2026 Jul 30. doi: 10.1007/s11357-026-02399-1. Online ahead of print. PMID 42530810

Eligibility

Who could join, as posted.

Sex: All
Age: from 45 Years up to 75 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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 same household.

PepBank is a research reference. Talk to a doctor before you use any peptide.