Clinical trial NCT06889740: Evaluate the Safety, Tolerability, and Efficacy of UthPeak NMNH (Reduced Nicotinamide Mononucleotide) in Healthy Adult Participants
Official title: A Prospective, Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of UthPeak NMNH (Reduced Nicotinamide Mononucleotide) in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Aging
Keywords: UthPeak
NMNH
reduced NMN
reduced nicotinamide mononucleotide
Lead sponsor: EffePharm LTD
Sponsor class: INDUSTRY
First posted: 2025-03-21
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study
Primary purpose: OTHER

Brief summary: This study is to assess the safety and tolerability of NMNH as a dietary supplement for human consumption. The current study aims to comprehensively evaluate its potential effects on pharmacokinetics, physical performance, biological age and overall quality of life. These findings will expand our understanding of NMNH therapeutic potential and guide its future clinical applications in anti-aging interventions.

Detailed description: A total of 80 healthy adult participants were considered for enrolment in the study based on predefined eligibility criteria and screening assessments, which included demographics, medical history, clinical laboratory tests, diagnostic evaluations, and prior medication review.

The 80 participants were randomly assigned to placebo group, NMNH 125 mg group, NMNH 250 mg group, or NMNH 500 mg group, and oral supplementation for 90 consecutive days.

Baseline assessments comprised NAD+ levels, BMI, biological age evaluation, a six-minute walking test, and a quality-of-life assessment. These parameters were also evaluated during Day 45 and day 90 . Participants were formally enrolled in the study after reconfirmation of eligibility.

Blood samples were collected at multiple time points (0h, 0.5h, 1h, 2h, 4h, 6h, 12h, and 24h) after the first dose of supplementation to assess NAD+ levels. Pharmacokinetic parameter assessments were conducted exclusively for the second set of 10 participants in each group who provided informed consent.

Throughout the study, physical examinations, vital signs, concomitant medications, and adverse events were recorded.

Eligibility criteria: Inclusion Criteria:

1. Adult healthy male/females aged 40 to 65 years.
2. Participants with Body Mass Index (BMI) between 18.5 and 35 kg/m2.
3. Participants who are willing to provide written Informed Consent for participating in the study
4. Participants who are able to follow verbal and written study directions.
5. Participants must be able to maintain consistent diet and lifestyle habits throughout the study.
6. Participants must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study.
7. Participants willing to administer assigned dietary supplements for 3 months.

Exclusion Criteria:

1. Participants on current use of prescription or over-the-counter nicotinic acid.
2. Participants using any statin drugs.
3. Participants having used any tobacco product or used a recreational drug in the past 6 months.
4. Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator.
5. Participants with documented presence of atherosclerotic disease and/or cardiopulmonary disease.
6. Participants with history of drug or alcohol abuse.
7. Participants with history of unstable depression or mental illness within the last 6 months for which the investigator believes could impact the participant's ability to comply with study requirements.
8. Participants unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the start of study.
9. Participants who are currently participating in or planning to begin a weight loss diet during the study period.
10. Participants who chronically use over-the-counter medication which would interfere with study endpoints.
11. Participants whose lifestyle or schedule incompatible with the study protocol.
12. Participants with known hypersensitivity to the drug components used during the study.
13. Female participants with positive result for urinary beta human chorionic gonadotropin or gestation period or breastfeeding.
14. 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.
15. Currently, or within the past 30 days, enrolled in a different clinical investigation.
16. Inability to provide a venous blood sample.
17. Unable or unwilling to provide written informed consent for participation in study.
18. 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.

Primary outcomes:
measure: To assess NAD+ Values in blood
timeFrame: day 0, day 45, day 90
measure: Assessment of Biological Age
timeFrame: day 0, day 45, day 90
measure: Physical Performance walking test
timeFrame: day 0, day 45, day 90
measure: Change in BMI
timeFrame: day 0, day 45, day 90
measure: Quality (QoL) Questionnaire
timeFrame: day 0, day 45, day 90
Secondary outcomes:
measure: Safety will be assessed based on number of adverse events
timeFrame: day 0, day 45, day 90
measure: Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events
timeFrame: day 0, day 45, day 90
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Medstar Speciality Hospital
state: Karnataka
city: Karaikal
country: India
facility: Vinayaka Mission's Medical College and Hospital
state: Puducherry
Study officials:
affiliation: Medstar Specialist Hospital
name: Chikkalingaiah Siddegowda
role: STUDY_DIRECTOR
References:
citation: Zapata-Perez R, Tammaro A, Schomakers BV, Scantlebery AML, Denis S, Elfrink HL, Giroud-Gerbetant J, Canto C, Lopez-Leonardo C, McIntyre RL, van Weeghel M, Sanchez-Ferrer A, Houtkooper RH. Reduced nicotinamide mononucleotide is a new and potent NAD+ precursor in mammalian cells and mice. FASEB J. 2021 Apr;35(4):e21456. doi: 10.1096/fj.202001826R.
citation: Smolin AG. Ab Initio Studies of NMNH(2-) Conformers in Water-Methanol Solutions: Comparative Analysis of the Biexponential Fluorescence Signals for NMNH(2-) and NADH. J Phys Chem B. 2022 Dec 29;126(51):10870-10881. doi: 10.1021/acs.jpcb.2c08220. Epub 2022 Dec 16.