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| Name | Class |
|---|---|
| ProRelix Research | INDUSTRY |
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This will be a multi-center, two arm study in 66 healthy adults. Subjects will complete a screening visit (V1, Day -7) to determine eligibility for the study based on Inclusion & Exclusion Criteria, patient history and safety measures. Eligibility confirmation will be done on visit 2 (Day 1). Patients successfully completing screen will be assigned to either of the two treatments. Subjects will receive the treatment for at-home use and will also be given diaries for recording information of medication, and adverse events. At 2 different intervals i.e. Day 30 and Day 60 (V3, V4) subjects will return to the clinic to review and collect patient diaries, safety data and medication reconciliation. Efficacy and safety assessments will be done at baseline, Day 30 and Day 60 .
Sixty-six healthy male or female middle-aged or older subjects will be assigned in 1:1 ratio to treatment with the test product, NMN or Placebo in this double-blind, randomized, placebo-controlled study. All 66 enrolled subjects will be instructed to take two capsules of either NMN or Placebo once a day after breakfast for 60 days daily. Subjects will be required to use diaries to document the date and time of study treatments including any missed doses and the occurrence of any adverse events.
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 been 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 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. Blinded investigational product will be dispensed to subjects who meet all the inclusion and none of the exclusion criteria. Subjects will be instructed to take two capsules of the either placebo or NMN once a day with ambient temperature water after breakfast. They shall be recording the dosing details in subject diaries. The first dose of Investigational Product will be taken by the subject at home. Subjects will be evaluated through SF-36 questionnaire for their health. They will be required to answer few 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 Products every time they visit the site. 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 drug applications.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Product | Experimental | Ingredient: NMN Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days |
|
| Placebo | Placebo Comparator | Ingredient: Starch powder Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NMN | Other | Investigational Product |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Blood cellular NAD+ concentration in serum | Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study | Day 2 |
| Blood cellular NAD+ concentration in serum | Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study | Day 30 |
| Blood cellular NAD+ concentration in serum | Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study | Day 60 |
| Blood cellular NADH concentration in serum | Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study | Day 2 |
| Blood cellular NADH concentration in serum | Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study | Day 30 |
| Blood cellular NADH concentration in serum | Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study | Day 60 |
| Six minutes walking endurance test | Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | Evaluation of Adverse events | Day 2 |
| Adverse events | Evaluation of Adverse events | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI | Monitoring of BMI inter group comparison from baseline to the end of study | Day 1 |
| BMI | Monitoring of BMI inter group comparison from baseline to the end of study |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ganesh Avhad | Swasthiye Clinic and Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dr Kamalakar Gajarae | Pune | Maharashtra | 411019 | India | ||
| Swasthiye Clinic and Research Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35821806 | Derived | Huang H. A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults. Front Aging. 2022 May 5;3:851698. doi: 10.3389/fragi.2022.851698. eCollection 2022. |
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A Multicenter, Randomized, Double-Blind, Placebo-Controlled
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Randomized, Double-Blind
| Other |
Starch Powder |
|
| Six minutes walking endurance test | Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study | Day 30 |
| Six minutes walking endurance test | Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study | Day 60 |
| Systolic | Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study | Day 2 |
| Systolic | Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study | Day 30 |
| Systolic | Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study | Day 60 |
| Diastolic blood pressure | Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study | Day 2 |
| Diastolic blood pressure | Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study | Day 30 |
| Diastolic blood pressure | Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study | Day 60 |
| Pulse pressure | Evaluation of Pulse Pressure inter group comparison from baseline to the end of study | Day 2 |
| Pulse pressure | Evaluation of Pulse Pressure inter group comparison from baseline to the end of study | Day 30 |
| Pulse pressure | Evaluation of Pulse Pressure inter group comparison from baseline to the end of study | Day 60 |
| SF-36 questionnaire | Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study | Day 2 |
| SF-36 questionnaire | Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study | Day 30 |
| SF-36 questionnaire | Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study | Day 60 |
| Adverse events | Evaluation of Adverse events | Day 60 |
| Laboratory parameter (blood chemistry) | Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study | Day 1 |
| Laboratory parameter (blood chemistry) | Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study | Day 30 |
| Laboratory parameter (blood chemistry) | Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study | Day 60 |
| Laboratory parameter (lipid profile) | Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study | Day 1 |
| Laboratory parameter (lipid profile) | Evaluation of Laboratory parameter (blood chemistry, lipid profile, LFT and RFT) changes from baseline to end of the study | Day 30 |
| Laboratory parameter (lipid profile) | Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study | Day 60 |
| Laboratory parameter (LFT ) | Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study | Day 1 |
| Laboratory parameter (LFT) | Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study | Day 30 |
| Laboratory parameter (LFT) | Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study | Day 60 |
| Laboratory parameter (RFT) | Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study | Day 1 |
| Laboratory parameter (RFT) | Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study | Day 30 |
| Laboratory parameter (RFT) | Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study | Day 60 |
| Drop out due to adverse events | Number of participants that dropout due to adverse events including lab values | Day 2 |
| Drop out due to adverse events | Number of participants that dropout due to adverse events including lab values | Day 30 |
| Drop out due to adverse events | Number of participants that dropout due to adverse events including lab values | Day 60 |
| Day 2 |
| BMI | Monitoring of BMI inter group comparison from baseline to the end of study | Day 30 |
| BMI | Monitoring of BMI inter group comparison from baseline to the end of study | Day 60 |
| HOMA | Monitoring of HOMA inter group comparison from baseline to the end of study | Day 2 |
| HOMA | Monitoring of HOMA inter group comparison from baseline to the end of study | Day 60 |
| Pune |
| Maharashtra |
| 411030 |
| India |