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

Not Applicable

Completed

• Conditions: Healthy Aging

• Registration Number: NCT06889740
• Lead Sponsor: EffePharm LTD

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.

Study Timeline

• Study Start: 2024-07-08
• Primary Completion: 2024-12-08
• Study Completion: 2025-01-25
• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-20
• Study First Posted: 2025-03-21
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess NAD+ Values in blood	day 0, day 45, day 90	To assess NAD+ Values in blood
Assessment of Biological Age	day 0, day 45, day 90	Assessment of Biological Age by an online biological age calculator
Physical Performance walking test	day 0, day 45, day 90	Physical Performance is assessed by endurance test measured on six minutes
Change in BMI	day 0, day 45, day 90	BMI
Quality (QoL) Questionnaire	day 0, day 45, day 90	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.

Secondary Outcome Measures

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

Trial Locations

Locations (2)

Medstar Speciality Hospital; 🇮🇳 Bengaluru, Karnataka, India

Vinayaka Mission's Medical College and Hospital; 🇮🇳 Karaikal, Puducherry, India