Evaluate the Safety, Tolerability, and Efficacy of UthPeak NMNH (Reduced Nicotinamide Mononucleotide) in Healthy Adult Participants

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Aging
• Intervention / Treatment: Other: Placebo; Other: NMNH

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bengaluru, Karnataka, India, 560092
      • Medstar Speciality Hospital
  • Puducherry
    • Karaikal, Puducherry, India, 609609
      • Vinayaka Mission's Medical College and Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Group 1; Ingredient: Starch Dosage form: Capsule, 125mg/capsule Frequency: 2 capsules per day Duration: 90 days	Other: Placebo; Starch powder
Experimental: Group 2; Ingredient: NMNH Dosage form: Capsule, 62.5 mg/capsule Frequency: 2 capsules per day Duration: 90 days	Other: NMNH; Reduced Nicotinamide Mononucleotide
Experimental: Group 3; Ingredient: NMNH Dosage form: Capsule, 125 mg/capsule Frequency: 2 capsules per day Duration: 90 days	Other: NMNH; Reduced Nicotinamide Mononucleotide
Experimental: Group 4; Ingredient: NMNH Dosage form: Capsule, 250 mg/capsule Frequency: 2 capsules per day Duration: 90 days	Other: NMNH; Reduced Nicotinamide Mononucleotide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess NAD+ Values in blood	To assess NAD+ Values in blood	day 0, day 45, day 90
Assessment of Biological Age	Assessment of Biological Age by an online biological age calculator	day 0, day 45, day 90
Physical Performance walking test	Physical Performance is assessed by endurance test measured on six minutes	day 0, day 45, day 90
Change in BMI	BMI	day 0, day 45, day 90
Quality (QoL) Questionnaire	The 36-Item Short Form Health Survey (SF-36) was used to assess Health-Related Quality of Life. It measures eight scales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores range from 0 to 100, with higher scores indicating a more favorable health state.	day 0, day 45, day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety will be assessed based on number of adverse events	Safety will be assessed based on number of adverse events	day 0, day 45, day 90
Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events	Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events	day 0, day 45, day 90

Collaborators and Investigators

• Sponsor: EffePharm LTD
• Investigators: Study Director: Jiayan Li, EffePharm LTD

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 8, 2024
• Primary Completion (Actual): December 8, 2024
• Study Completion (Actual): January 25, 2025

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 20, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Actual): July 4, 2025
• Last Update Submitted That Met QC Criteria: July 2, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: UthPeak; NMNH; reduced NMN; reduced nicotinamide mononucleotide
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites; Micronutrients; Vitamin B Complex; Vitamins; Vasodilator Agents; Hypolipidemic Agents; Lipid Regulating Agents; Niacin; Niacinamide; Nicotinic Acids
• Other Study ID Numbers: Study No. EP_RNM_001_24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No