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NOT YET RECRUITING
NCT07880925
PHASE1

Effects of Trigonelline Monohydrate on NAD+ Metabolism, Pharmacokinetics, Safety, and Tolerability in Healthy Adults

Sponsor: dsm-firmenich Switzerland AG

View on ClinicalTrials.gov

Summary

This Phase 1 study is designed to evaluate the pharmacokinetic, pharmacodynamic, bioavailability, safety, and tolerability effects of trigonelline monohydrate in generally healthy adults aged 40 to 70 years. Sixty participants will be randomized in a double-blind, parallel-arm study to receive one of four doses of trigonelline monohydrate (equivalent to 150 mg, 300 mg, 450 mg, or 600 mg of trigonelline daily), an active comparator (600 mg nicotinamide mononucleotide \[NMN\]), or placebo for 4 weeks. The primary objective is to assess the effect of trigonelline monohydrate supplementation on NAD+ metabolism by measuring the change from baseline in whole blood NAD+ concentrations after 4 weeks of supplementation. Secondary objectives include evaluation of trigonelline pharmacokinetics, bioavailability, plasma accumulation following repeated dosing, effects on NAD-related metabolites, and urinary excretion of trigonelline and NAD-related metabolites. Safety and tolerability will be assessed through adverse events, vital signs, anthropometric measurements, and clinical laboratory assessments. Exploratory analyses will examine inflammatory biomarkers and additional NAD-related metabolic outcomes.

Official title: A Randomized, Double-blind, Parallel-arm, Comparator- and Placebo-controlled Clinical Study to Evaluate the Pharmacokinetic and Pharmacodynamic Effects, Bioavailability, Safety, and Tolerability of Trigonelline Monohydrate in Healthy Adults Aged 40 to 70

Key Details

Gender

All

Age Range

40 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-10

Completion Date

2027-01

Last Updated

2026-10-19

Healthy Volunteers

Yes

Interventions

DIETARY_SUPPLEMENT

Nicotinamide Mononucleotide (NMN)

Nicotinamide mononucleotide (NMN) 600 mg/day administered orally as 3 capsules once daily for approximately 4 weeks.

OTHER

Placebo

Matching placebo administered orally as 3 capsules once daily for approximately 4 weeks.

DIETARY_SUPPLEMENT

Trigonelline Monohydrate

Trigonelline monohydrate administered orally as 3 capsules once daily for approximately 4 weeks. Dose levels include 170 mg, 340 mg, 510 mg, and 680 mg trigonelline monohydrate, equivalent to 150 mg, 300 mg, 450 mg, and 600 mg trigonelline, respectively.

Locations (1)

Apex Trials

Guelph, Ontario - on, Canada