Clinical trial Recruiting at 1 site Phase 1 Interventional Ages 40 to 70

Trigonelline Monohydrate for NAD+ Metabolism in Healthy Adults

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

Run by dsm-firmenich Switzerland AG · NCT07880925 · Data updated 2026-11-12

A small study in healthy adults tests whether taking trigonelline monohydrate by mouth for 4 weeks can change NAD+ levels and how the body handles the supplement, compared with NMN and placebo.

More Pharmacokinetics trials

Quick facts

PhasePhase 1
Study typeInterventional
Ages40 Years to 70 Years
SexAll
Enrollment60 (estimated)
Sponsordsm-firmenich Switzerland AG
Industry-sponsored
Locations1 site (Guelph, Ontario - on)
StatusRecruiting
StartedNovember 2026
Main results expectedJanuary 2027
Study endsJanuary 2027
Registry record updatedNovember 5, 2026
Trial IDNCT07880925 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults 40–70 in good health, non-smokers, with BMI 18.5–29.9, and suitable venous access who can take capsules as directed for 4 weeks.

Probably not a fit

Participants with health conditions or risk factors that affect NAD+ metabolism or those who experience adverse reactions to study products may see no benefit.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, randomized, double-blind, parallel-arm study will evaluate pharmacokinetics, pharmacodynamics, bioavailability, safety, and tolerability of four daily doses of trigonelline monohydrate (150, 300, 450, or 600 mg), an NMN active comparator, or placebo in 60 generally healthy adults aged 40–70 over about four weeks. Primary endpoints include change from baseline in whole-blood NAD+ after treatment. Secondary goals assess plasma and urinary metabolites, accumulation with repeated dosing, and safety signals. The trial uses a 1:1:1:1:1:1 allocation and will collect blood and urine samples to characterize absorption, metabolism, and potential NAD+-related effects.

Why it matters

Potential benefit: If successful, the study could inform dosing guidance and safety for NAD+-related interventions in adults.

How similar studies have gone: Prior human data on trigonelline for NAD+ metabolism are limited, making this study relatively exploratory but builds on existing preclinical signals.

Who can join: the full rules

Show full inclusion / exclusion criteria
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.

Where it's running

  • Apex Trials
    Guelph, Ontario - on, Canada
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Levetiracetam Dosing in Critically Ill on CRRT

    This study tests how levetiracetam behaves in the bodies of adults on continuous renal replacement therapy to help figure out the best dosing.

    Recruiting Chulalongkorn University · Pathum Wan, Bangkok · NCT07918833

  • Cetuximab bioequivalence test in healthy men

    This study tests whether a cetuximab injection is bioequivalent to Erbitux in healthy men to see if they behave the same in the body.

    Recruiting Phase 1 HC Biopharma Inc. · Haikou, Hainan · NCT07813468

  • GenSci142 as a vaginal treatment for bacterial vaginosis

    This study tests whether GenSci142 given as vaginal doses is safe and may help BV patients aged 18–50 compared with clindamycin cream.

    Recruiting at 9 sites Phase 1 Changchun GeneScience Pharmaceutical Co., Ltd. · Beijing, Beijing Municipality and 8 other locations · NCT07663838

  • Tart cherry absorption from shelf-stable military ration items

    This project will test whether eating shelf-stable bars or powdered drinks made with tart cherry powder changes how well adults (including active-duty military) absorb tart cherry compounds.

    Recruiting United States Army Research Institute of Environmental Medicine · Natick, Massachusetts · NCT07063173

  • Food's effect on how DW-1021 (pelubiprofen 45 mg + tramadol 45.9 mg) is absorbed in healthy adults

    This study will test whether eating a high-fat meal changes how DW-1021 (pelubiprofen plus tramadol) is absorbed in healthy adult men.

    Recruiting at 2 sites Phase 1 Haiphong University of Medicine and Pharmacy · Haiphong, Hai Phong and 1 other locations · NCT07060209

  • High-potency cannabis effects immediately and after a short break

    This test will try smoked cannabis at about 50 mg and 100 mg THC versus placebo in adults who smoke cannabis nearly every day to see how it affects them right away and after a short period without use.

    Recruiting Phase 1 University of California, Los Angeles · Los Angeles, California · NCT06859723

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.