Trial · Interventional
Not yet recruitingPhase 1Registry dataEffects of Trigonelline Monohydrate on NAD+ Metabolism, Pharmacokinetics, Safety, and Tolerability in Healthy Adults
Overview
- Status
- Not yet recruiting
- Phase
- Phase 1
- Enrollment
- 60 participants (estimated)
- Sponsor
- dsm-firmenich Switzerland AG · Industry
- Design
- Randomized · Quadruple masking
- Countries
1 country
Canada
- Start
- Oct 2026 (estimated)
- Primary completion
- Jan 2027 (estimated)
- Completion
- Jan 2027 (estimated)
- First posted
- 19 Oct 2026
- Last update posted
- 19 Oct 2026
- Conditions
- NAD+ Metabolism · Pharmacokinetics · Bioavailability · Healthy Adults
Timeline
1 trial · 1 not yet recruiting
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
- Ph 1
Effects of Trigonelline Monohydrate on NAD+ Metabolism, Pharmacokinetics, Safety, and Tolerability in Healthy Adults
NCT07880925est. Oct 2026 to est. Jan 2027
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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.
Interventions
- Nicotinamide Mononucleotide (NMN)Dietary supplement
- PlaceboOther
- Trigonelline MonohydrateDietary supplement
Arms6
Experimental
Trigonelline Monohydrate 170 mg
Participants receive 170 mg of trigonelline monohydrate (equivalent to 150 mg trigonelline) administered orally as 3 capsules once daily for approximately 4 weeks.
Experimental
Trigonelline Monohydrate 340 mg
Participants receive 340 mg of trigonelline monohydrate (equivalent to 300 mg trigonelline) administered orally as 3 capsules once daily for approximately 4 weeks.
Experimental
Trigonelline Monohydrate 510 mg
Participants receive 510 mg of trigonelline monohydrate (equivalent to 450 mg trigonelline) administered orally as 3 capsules once daily for approximately 4 weeks.
Experimental
Trigonelline Monohydrate 680 mg
Participants receive 680 mg of trigonelline monohydrate (equivalent to 600 mg trigonelline) administered orally as 3 capsules once daily for approximately 4 weeks.
Active comparator
Nicotinamide Mononucleotide (NMN) 600 mg
Participants receive 600 mg of nicotinamide mononucleotide (NMN) administered orally as 3 capsules once daily for approximately 4 weeks.
Placebo comparator
Placebo
Participants receive matching placebo capsules administered orally as 3 capsules once daily for approximately 4 weeks.
Primary outcomes1
Outcomes the sponsor listed as primary.
To assess the effect of TP daily supplementation on NAD metabolism, as measured by NAD+ concentrations in blood compared to placebo
Time frame · Baseline (Day 1 pre-dose [-60 min]) and Week 4 (Day 29 ±2 days, pre-dose)
Registry description
Circulating NAD+ levels in whole blood via liquid LC-MS
Secondary outcomes(12)
To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo
Time frame · Over 24 hours following a single dose on Day 1 (pre-dose, 0.25, 0.5, 1, 2, 3, 4, 6, 8, 10, 12, and 24 hours post-dose)
Registry description
PK parameter for plasma trigonelline: AUC0-24
To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo
Time frame · Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose)
Registry description
PK parameter for plasma trigonelline: Cmax
To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo
Time frame · Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose)
Registry description
PK parameter for plasma trigonelline: Tmax
To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo
Time frame · Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose)
Registry description
PK parameter for plasma trigonelline: T½
To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo
Time frame · Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose)
Registry description
PK parameter for plasma trigonelline: AUCinf
To determine the bioavailability and PK of single dose TP among different doses of TP and compared to a comparator and placebo
Time frame · Over 24 hours following a single dose on Day 1 (pre-dose through 24 hours post-dose)
Registry description
PK parameter for plasma trigonelline: AUC0-24:AUCinf
To determine the potential accumulation of TP in plasma among different doses of TP and compared to a comparator and placebo after multiple-day dosing
Time frame · Baseline (Day 1 pre-dose) and Week 4 (within 24 ±60 hours of the last dose)
Registry description
Change in trough plasma trigonelline concentration
To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo
Time frame · Baseline (Day 1 pre-dose) and 4 hours post-first dose
Registry description
Change in whole blood NAD-related metabolites measured via LC-MS
To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo
Time frame · Baseline (Day 1 pre-dose) and 8 hours post-first dose
Registry description
Change in whole blood NAD-related metabolites measured via LC-MS
To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo
Time frame · Baseline (Day 1 pre-dose) and 24 hours post-first dose (Day 2)
Registry description
Change in whole blood NAD-related metabolites measured via LC-MS
To evaluate the pharmacodynamic effects of the TP on NAD metabolism over time compared to a comparator and placebo
Time frame · Baseline (Day 1 pre-dose) and Week 4 (Day 29 ±2 days, pre-dose)
Registry description
Change in whole blood NAD-related metabolites measured via LC-MS
To assess the effects of TP on 24-hour urinary excretion of trigonelline and NAD-related metabolites compared to a comparator and placebo
Time frame · Over 24 hours following acute dosing on Day 1 and over 24 hours following the final dose at Week 4
Registry description
24-hour urinary excretion of trigonelline and NAD-related metabolites
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.
A trial that is still running, or that stopped early, may post results later.
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.
Eligibility
Who could join, as posted.
- Sex
- All
- Age
- from 40 Years up to 70 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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