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| Name | Class |
|---|---|
| ProRelix Research | INDUSTRY |
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It will be a two-part study. Part I will be six arms; randomized, double blind, parallel design, placebo-controlled dose ranging study. Part II will be open-label single dose study at the highest dose.
A total of 90 Subjects (Part 1 & Part 2) will be enrolled in the study. The Part 1 group subjects (80 Subjects) shall be randomly distributed between the six arms, i.e. 20 Subjects each in IP arms, and 7, 7 and 6 subjects in corresponding placebo arms.
All Part 2 Group subjects (10 Subjects) will be assigned into the cluster where all receive the maximum NMN dose (900 mg)
It will be a two-part study. Part I will be six arms; randomized, double blind, parallel design, placebo-controlled dose ranging study. Part II will be open-label single dose study at the highest dose.
Total number of Subjects is N = 90 (Part 1 & Part 2) Part I: six arms Arm A = 300 mg NMN supplement (n = 20) Arm B = Placebo of 300 mg NMN supplement (n = 07) Arm C = 600 mg NMN supplement (n = 20) Arm D = Placebo of 600 mg NMN supplement (n = 07) Arm E = 900 mg NMN supplement (n = 20) Arm F = Placebo of 900 mg NMN supplement (n = 06) Part II 900 mg NMN supplement (n = 10) Duration of Protocol Therapy = 60 Days Study Population= Middle aged or older male or female subjects (40-65 years)
The duration of each subject's participation in the study will be of 60 days. Scheduled study visits will include:
During Visit 1 (Screening), informed consent will be obtained before any study procedures take place. After subject has consented, medical history will then be documented, including the concomitant medications (if any). Physical examination and ECG will be carried out for all subjects. Subjects' vital signs will be recorded along with pulse pressure (PP). Their laboratory investigations like Hematology, Clinical chemistry and Urinalysis will be done. They will be symptomatically assessed for COVID-19. They shall undergo the screening procedure by inclusion and exclusion criteria. Subject's demography data will be collected. They will be given instructions for the next visit.
At Visit 2 (Day 1, Baseline visit), eligibility confirmation will be done, and each enrolled subject will be randomly assigned in double-blind fashion, in 1:1 ratio to the test product or the Placebo or to the maximum dose group (Part 2 subjects). Blinded investigational product will be dispensed to subjects for Part 1 who meet all the inclusion and none of the exclusion criteria. Part 2 group subjects will be dispensed with maximum dose of NMN (900mg) without any blinding. Subjects will be instructed to take two to six capsules (depending on thegroups that the subjects fall under) of the either placebo or NMN once a day with ambient temperature water before breakfast. They shall be recording the dosing details in subject diaries. The Investigational Product will be taken by the subject at home right from the first dose. Subjects will be evaluated through SF-36 questionnaire for their health. They will be required to answer the list of questions pertaining to their health. (PI, CRC or site staff will fill SF-36 questionnaire in visit 2, 3 and 4 by asking the subject). All the baseline assessments for efficacy will be performed.
At visit 3 (Day 30) and visit 4 (Day 60), subjects will return to the clinic to review and collect subjects' diaries, safety data and medication reconciliation. Efficacy and safety assessments will be done at both the visits.
Subjects will be asked to bring their subject diaries and used/unused Investigational Product every time they visit the site(empty bottles in case of used IP). Enough quantity of Investigational Product will be dispensed every visit. Subjects' vital signs will be recorded along with pulse pressure (PP) at all visits. Adverse event assessment and concomitant assessment will be done at each visit along with compliance with study supplement administration.
End points:
Primary efficacy endpoints (Part I ) Blood cellular NAD/NADH concentration in serum [ Time Frame: Baseline, 1 month and 2 Months] Six minutes walking endurance test [ Time Frame: Baseline, 1 month and 2 Months] SF-36 questionnaire [ Time Frame: Baseline, 1 month and 2 Months]
Secondary endpoints :
Exploratory endpoints :
Primary Endpoints : (Part II)
Evaluation will include the following parameters:
Secondary endpoint:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A = 300 mg NMN supplement (n = 20) | Active Comparator | Subjects who are assigned to 300 mg arm (NMN) will be instructed to take 2 capsules after breakfast once a day with ambient temperature water for 60 days. |
|
| Arm B = Placebo 300 mg (n=07) | Placebo Comparator | Subjects who are assigned to 300 mg arm (placebo) will be instructed to take 2 capsules after breakfast once a day with ambient temperature water for 60 days. |
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| Arm C = NMN Supplement 600 mg (n= 20) | Active Comparator | Subjects who are assigned to 600 mg arm (NMN) will be instructed to take 4 capsules after breakfast once a day with ambient temperature water for 60 days. |
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| Arm D = Placebo 600 mg (n=07) | Placebo Comparator | Subjects who are assigned to 600 mg arm (Placebo) will be instructed to take 4 capsules after breakfast once a day with ambient temperature water for 60 days. |
|
| Arm E = NMN Supplement 900 mg (n=10) | Active Comparator | Subjects who are assigned to 900 mg arm (NMN) will be instructed to take 6 capsules after breakfast once a day with ambient temperature water for 60 days. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotinamide Mononucleotide | Drug | Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor in all living cells involved in fundamental biological processes. Depletion in the levels of NAD+ is associated with traits of aging, many age-related diseases like cancer, metabolic disorders and neurological disorders. Evidence stemming from recent studies have unveiled numerous roles of NAD+ metabolism on aging and longevity and delaying the progression of age-related diseases |
| Measure | Description | Time Frame |
|---|---|---|
| Blood cellular NAD+/ NADH | Blood cellular NAD+ / NADH concentration in serum | Baseline |
| Blood cellular NAD+/ NADH | Blood cellular NAD+ / NADH concentration in serum | 1 month |
| Blood cellular NAD+/ NADH | Blood cellular NAD+ / NADH concentration in serum | 2 month |
| Six walking endurance test | Six minutes walking endurance test | Baseline |
| Six walking endurance test | Six minutes walking endurance test | 1 month |
| Six walking endurance test | Six minutes walking endurance test | 2 month |
| SF-36 questionnaire | Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study. | Baseline |
| SF-36 questionnaire | Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study. |
| Measure | Description | Time Frame |
|---|---|---|
| safety of NMN | To compare the safety of NMN versus placebo | Baseline |
| safety of NMN | Monitoring and documentation of number and types of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT) |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. | Baseline |
| BMI | Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness. |
Inclusion Criteria: (Applicable to both parts)
Exclusion Criteria: (Applicable to both parts).
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| Name | Affiliation | Role |
|---|---|---|
| Mr.Lin Yi | Abinopharm, Inc | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Swasthiya Clinic and Research Center | Pune | Maharashtra | 411030 | India | ||
| Sunad Ayurved |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36482258 | Derived | Yi L, Maier AB, Tao R, Lin Z, Vaidya A, Pendse S, Thasma S, Andhalkar N, Avhad G, Kumbhar V. The efficacy and safety of beta-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial. Geroscience. 2023 Feb;45(1):29-43. doi: 10.1007/s11357-022-00705-1. Epub 2022 Dec 8. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jan 17, 2022 | |
| Reset | Mar 22, 2022 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jan 17, 2022 | Mar 22, 2022 |
| ID | Term |
|---|---|
| D009537 | Nicotinamide Mononucleotide |
| ID | Term |
|---|---|
| D012265 | Ribonucleotides |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
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| Arm F = Placebo 900 mg (n=06) | Placebo Comparator | Subjects who are assigned to 900 mg arm (Placebo) will be instructed to take 6 capsules after breakfast once a day with ambient temperature water for 60 days. |
|
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| Placebo | Other | Rice flour in white capsule resembling NMN |
|
| 1 month |
| SF-36 questionnaire | Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study. | 2 month |
| PART II : Telomerase test results | Telomere are repetitive nucleotide elements at the end of chromosomes that protect chromosomes from degradation and genetic information loss.In this study we will be doing absolute Human telomere length quantification qPCR assay using a RUO commercial kit. The method uses delta Cq method for calculating relative telomere length with reference DNA used. | Baseline |
| PART II : Telomerase test results | Telomere are repetitive nucleotide elements at the end of chromosomes that protect chromosomes from degradation and genetic information loss.In this study we will be doing absolute Human telomere length quantification qPCR assay using a RUO commercial kit. The method uses delta Cq method for calculating relative telomere length with reference DNA used. | 2 Months |
| PART II : SF-36 questionnaire | Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study. | Baseline |
| PART II : SF-36 questionnaire | Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study. | 2 months |
| 2 Months |
| Tolerability of NMN | Number of participants that drop out due to adverse events including lab values. Monitoring ad documentation of subject drop out due to adverse events. | Baseline |
| Tolerability of NMN | Number of participants that drop out due to adverse events including lab values. Monitoring ad documentation of subject drop out due to adverse events. | 2 months |
| Safety of the different NMN doses | Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT) | 2 Months |
| Tolerability different NMN doses | Number of participants that drop out due to adverse events including lab values | Baseline |
| Tolerability different NMN doses | Number of participants that drop out due to adverse events including lab values | 2 Months |
| PART II : Safety of NMN | Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT) | Baseline |
| PART II : Safety of NMN | Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT) | 2 Months |
| 2 months |
| HOMA (Homeostatic model assessment) | Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. | Baseline |
| HOMA (Homeostatic model assessment) | Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations. | 2 months |
| Biological Age using Aging.Ai 3.0 calculator | Biological age, also referred to as physiological age, takes many lifestyle factors into consideration, including diet, exercise and sleeping habits, to name a few. | Baseline |
| Biological Age using Aging.Ai 3.0 calculator | Biological age, also referred to as physiological age, takes many lifestyle factors into consideration, including diet, exercise and sleeping habits, to name a few. | 2 Months |
| Pune |
| Maharashtra |
| 411033 |
| India |