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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Placebo Comparator | Ingredient: Starch Dosage form: Capsule, 125mg/capsule Frequency: 2 capsules per day Duration: 90 days |
|
| Group 2 | Experimental | Ingredient: NMNH Dosage form: Capsule, 62.5 mg/capsule Frequency: 2 capsules per day Duration: 90 days |
|
| Group 3 | Experimental | Ingredient: NMNH Dosage form: Capsule, 125 mg/capsule Frequency: 2 capsules per day Duration: 90 days |
|
| Group 4 | Experimental | Ingredient: NMNH Dosage form: Capsule, 250 mg/capsule Frequency: 2 capsules per day Duration: 90 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMNH | Other | Reduced Nicotinamide Mononucleotide |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jiayan Li | EffePharm LTD | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medstar Speciality Hospital | Bengaluru | Karnataka | 560092 | India | ||
| Vinayaka Mission's Medical College and Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33724555 | Result | 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. | |
| 36524597 |
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Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study
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Double-blind
| Placebo |
| Other |
Starch powder |
|
Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events
| day 0, day 45, day 90 |
| Kāraikāl |
| Puducherry |
| 609609 |
| India |
| 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. |