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

NCT06889740 | Completed DMC

• 1 other identifier: Study No. EP_RNM_001_24
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Healthy Aging

Keywords

UthPeak; NMNH; reduced NMN; reduced nicotinamide mononucleotide

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (2)

• 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

  day 0, day 45, day 90

Study Arms (4)

Group 1

PLACEBO COMPARATOR

Ingredient: Starch Dosage form: Capsule, 125mg/capsule Frequency: 2 capsules per day Duration: 90 days

Other: Placebo

Group 2

EXPERIMENTAL

Ingredient: NMNH Dosage form: Capsule, 62.5 mg/capsule Frequency: 2 capsules per day Duration: 90 days

Other: NMNH

Group 3

EXPERIMENTAL

Ingredient: NMNH Dosage form: Capsule, 125 mg/capsule Frequency: 2 capsules per day Duration: 90 days

Other: NMNH

Group 4

EXPERIMENTAL

Ingredient: NMNH Dosage form: Capsule, 250 mg/capsule Frequency: 2 capsules per day Duration: 90 days

Other: NMNH

Interventions

NMNH OTHER

Reduced Nicotinamide Mononucleotide

Group 2; Group 3; Group 4

Placebo OTHER

Starch powder

Group 1

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 able to maintain consistent diet and lifestyle habits throughout the study.
• 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 3 months.

You may not qualify if:

• Participants on current use of prescription or over-the-counter nicotinic acid.
• 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 history of drug or alcohol abuse.
• 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.
• 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.

Sponsors & Collaborators

• EffePharm LTD: lead

Study Sites (2)

Medstar Speciality Hospital

Bengaluru, Karnataka, 560092, India

Location

Vinayaka Mission's Medical College and Hospital

Kāraikāl, Puducherry, 609609, India

Location

Related Publications (2)

• 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.

  PMID: 33724555 BACKGROUND

• 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.

  PMID: 36524597 BACKGROUND

Study Officials

• Jiayan Li

  EffePharm LTD

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double-blind
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: July 8, 2024
• Primary Completion: December 8, 2024
• Study Completion: January 25, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)