Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3)
Condition: Aging
Study type: Interventional

Summary: 
      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 .
    

Detailed description: 
      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:

        -  Visit 1 (Screening, Day -4)

        -  Visit 2 (Baseline/Randomization visit, Day 1)

        -  Visit 3 (Day 30).

        -  Visit 4 (End of study, Day 60) A window (± 2 days) will be considered acceptable for
           each scheduled visit following the baseline visit.

      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.
    

Intervention name(s): NMN; Placebo
Intervention type(s): Other; Other
Intervention description(s): Investigational Product; Starch Powder
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Anti- Aging; Workout Enhancer