Skip to content

Trial · Interventional

Not yet recruitingPhase 1Registry data

Effects 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
202620272028
  1. Ph 1

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

    NCT07880925

    est. 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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
Inclusion Criteria: * Adults who are 40 to 70 years of age (inclusive) at the time of signing the informed consent. * Are able to consume study product capsules whole without chewing. * Have suitable veins for repeated venipuncture. * Non-smokers (including nicotine vaping) and have not used any nicotine products (patches, gums, etc.) for \> 3 months prior to Visit 2. Non-smoker is defined as someone who does not habitually/regularly use products containing nicotine and willing to abstain for 14 days before Visit 2 until the last procedure. * In otherwise good general health, as deemed by the investigator (based on a review of medical history, vital signs, laboratory safety tests, and physical examination if performed at screening). * Have a BMI between 18.5 to 29.9 kg/m2 (inclusive) and weigh no less than 50.0 kg. * Have maintained consistent dietary habits, including medication and supplement intake, and lifestyle for the last 3 months before screening and agree to maintain them throughout the study (unless required per the restrictions). * Agree to follow the restrictions on concomitant treatments. * Agree to follow the restrictions on lifestyle. * Agree to use acceptable contraceptive methods. * Willing and able to agree to the requirements of this study, be willing to give voluntary consent, and carry out all study-related procedures. * Willing and able to comply with the protocol, including: 1. Agree to consume the standardized meals provided at the site during Visit 2 2. Agree to fast overnight, i.e., no food or liquids except for water for a minimum 8 hours prior to applicable visits Exclusion Criteria: * Individuals of CBP who are pregnant, intending to breastfeed, or intending to conceive at the time of consent and during the study, or demonstrate a positive pregnancy test. * Have a known sensitivity, intolerability, or allergy to any of the standardized meals/snacks, study products, their excipients, or to any known allergens that may be present due to potential cross-contamination during manufacturing or processing. * Have positive screening tests for drugs or cotinine screening. * Have positive alcohol breath test at screening. * Have high BP (≥140 systolic or ≥90 diastolic mmHg). * Have clinically significant abnormal vital signs that in the opinion of the investigator may be of a concern for the study or participant safety. * Have clinically significant abnormal safety laboratory assessment values in the opinion of the investigator at screening. * Have current symptoms, or symptoms within the past 7 days of baseline, of an acute infection (e.g., fever, respiratory symptoms such as persistent cough or difficulty breathing), that may influence study outcomes as assessed by the investigator. * Have Type I or II diabetes, thyroid disease, or non-stable asthma or chronic obstructive pulmonary disease (COPD). * Reports a clinically significant illness during the 28 days before the first dose of study product. * Have any abnormality, obstruction, or disorder of the gastrointestinal tract that may preclude swallowing (e.g., dysphagia) or impair gastrointestinal motility, digestion, or absorption (e.g., known intestinal malabsorption, celiac disease, inflammatory bowel disease \[including Crohn's disease or ulcerative colitis\], chronic pancreatitis, or steatorrhea). * Have any history of gastrointestinal surgery or anatomical abnormality that, in the opinion of the investigator, may affect the oral absorption of the study product. * Have current or a history of hematological disorders (e.g., sickle cell anemia or thalassemia), cerebrovascular disease, heart/cardiovascular disease (e.g., coronary artery disease, heart failure, stroke, peripheral vascular disease), renal disease (dialysis or renal failure), hepatic impairment/disease, neurological disorders (e.g., dementia or Parkinson's disease), immune disorders and/or immunocompromised (i.e., HIV/AIDS). * Have a history of cancer (except localized skin cancer without metastases or in situ cervical cancer), unless recovery occurred more than 5 years before the screening visit. * Are receiving treatments for or have been hospitalized in the last 12 months for psychiatric disorders (e.g., depression, bipolar disorder, schizophrenia, etc.) that may affect the participant's capability to carry out all procedures of the study at the investigator's discretion. * Major surgery in 3 months prior to screening or planned major surgery during the study. * Currently consumes, on average, more than 2 standard alcoholic beverages a day where one standard drink is defined as approximately as 330 mL (12 oz) of beer (\~5% alcohol), 150 mL (5 oz) of wine (\~12% alcohol), 40 mL (1.5 oz) of distilled spirits (e.g., vodka, whiskey, gin; \~40% alcohol). * Have a history of alcohol or substance abuse in the 12 months prior to screening (including having been hospitalized for such in an in-patient or out-patient intervention program) or use that in the opinion of the investigator may be of a concern for the study. * Reports a significant blood loss or blood donation totaling between 101 mL to 449 mL of blood within 30 days prior to baseline or a blood donation of more than 450 mL within 56 days prior to baseline. * Reports donating plasma (e.g., plasmapheresis) within 15 days prior to baseline. * Current enrolment or past participation in another study with any product(s) with at least one active ingredient within 30 days before first dose of study product or longer, if the previous test product is deemed by the investigator to have lasting effects that might influence the eligibility criteria or outcomes of current study. * Living in the same household as another currently/previously enrolled participant in the present study. * Any other medical condition/situation or use of medications/supplements/therapies that, in the opinion of the investigator, may adversely affect the participant's ability to participate in the study or its measures or pose a significant risk to the participant.

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