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A planned clinical study at a single center will investigate the pharmacokinetics of NMN and NAM in healthy adults. This study will be interventional, involving a single dose, multiple arms, and will be randomized, open-label, and cross-over in design.

A prospective, single center, interventional, Multiple dose, multiple-arm, randomized, open label, cross-over, clinical study to evaluate pharmacokinetics of NMN & NAM in healthy adult participants

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/03/083101
Enrollment
10
Registered
2025-03-21
Start date
Unknown
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: NAM: NAM: 36.5mg NAM - 110 mg NAM- 219 mg Control Intervention1: NMN: NMN: 100 mg NMN: 300 mg NMN: 600 mg

Sponsors

Dr. Chikkalingaiah Siddegowda
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: -Adult healthy male/females aged 40 to 65 years. -Participants with Body Mass Index (BMI) between 18.5 and 35 kg/m2. -Participants who are willing to provide written Informed Consent for participating in the study -Participants who are able to follow verbal and written study directions. -Participants must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study. -Participants willing to administer assigned dietary supplements for the study duration. -Participants willing to avoid nutritional yeast, whey proteins, energy drinks, dairy products, grapefruit, grapefruit juice, and alcohol for 7 days prior to enrollment and throughout the study period.

Exclusion criteria

Exclusion criteria: -Participants using prescription or over-the-counter nicotinic acid, niacin, nicotinamide mononucleotide, nicotinamide riboside, or any other NAD+ precursors, Vitamin B3, or its derivatives within 14 days prior to enrolment and throughout the study duration. -Participants using any statin drugs. -Participants having used any tobacco product or used a recreational drug in the past 6 months. -Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator. -Participants with documented presence of atherosclerotic disease and/or cardiopulmonary disease. -Participants with a medical history or active diagnosis of chronic diseases or conditions affecting the urinary, cardiovascular, neuroendocrine (including diabetes), immune, central nervous, hematopoietic, gastrointestinal, hepatic, or visual systems, hereditary diseases, or other significant systemic disorders, as well as those with acute infectious diseases within 28 days prior to the study, known allergies or positive test results for sexually transmitted infections such as HIV, hepatitis B, hepatitis C, or syphilis. -Participants with history of drug or alcohol abuse within the past 6 months -Participants who smoked more than 10 cigarettes a day within one year before screening. -Participants with history of unstable depression or mental illness within the last 6 months for which the investigator believes could impact the participants ability to comply with study requirements. -Participants unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the start of study. -Participants who are currently participating in or planning to begin a weight loss diet during the study period. -Participants who chronically use over-the-counter medication which would interfere with study endpoints. -Participants whose lifestyle or schedule incompatible with the study protocol. -Participants with known hypersensitivity to the drug components used during the study. -Female participants with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding. -Other diseases or medications, according to the investigator, that would interfere directly in the results of the study or jeopardize the health of the participant. -Currently, or within the past 30 days, enrolled in a different clinical investigation. -Inability to provide a venous blood sample. -Patients with a current diagnosis of any form of cancer within the past 5 years, regardless of disease stage or treatment status, are ineligible for participation in this clinical trial. Any history of cancer within this timeframe must be documented and confirmed through medical records or pathology reports.

Design outcomes

Primary

MeasureTime frame
Plasma concentrations of the following parameters: NAD+, NMN, NAM, MeNam, 2-Pyr, 4-Pyr Erythrocyte concentrations of NAD+Timepoint: [Time frame: 0h, 1h, 2h, 4h, 8h, 12h, 24h]

Secondary

MeasureTime frame
Urine concentrations of the following parameters: NAM, MeNam, 2-Pyr, 4-PyrTimepoint: [Time frame: 0h, 1h, 2h, 4h, 8h, 12h, 24h]

Countries

India

Contacts

Public ContactDr Chikkalingaiah Siddegowda

Medstar Specialist Hospital

drchikkalingaiahmedstar@gmail.com9884457106

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026