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Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3) (NMN)

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ClinicalTrials.gov Identifier: NCT04228640
Recruitment Status : Completed
First Posted : January 14, 2020
Last Update Posted : April 1, 2021
Sponsor:
Collaborator:
ProRelix Services LLP
Information provided by (Responsible Party):
EffePharm LTD

Tracking Information
First Submitted Date  ICMJE January 9, 2020
First Posted Date  ICMJE January 14, 2020
Last Update Posted Date April 1, 2021
Actual Study Start Date  ICMJE December 15, 2020
Actual Primary Completion Date February 27, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Blood cellular NAD+ concentration in serum [ Time Frame: Day 2 ]
    Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study
  • Blood cellular NAD+ concentration in serum [ Time Frame: Day 30 ]
    Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study
  • Blood cellular NAD+ concentration in serum [ Time Frame: Day 60 ]
    Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study
  • Blood cellular NADH concentration in serum [ Time Frame: Day 2 ]
    Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study
  • Blood cellular NADH concentration in serum [ Time Frame: Day 30 ]
    Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study
  • Blood cellular NADH concentration in serum [ Time Frame: Day 60 ]
    Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study
  • Six minutes walking endurance test [ Time Frame: Day 2 ]
    Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
  • Six minutes walking endurance test [ Time Frame: Day 30 ]
    Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
  • Six minutes walking endurance test [ Time Frame: Day 60 ]
    Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
  • Systolic [ Time Frame: Day 2 ]
    Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
  • Systolic [ Time Frame: Day 30 ]
    Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
  • Systolic [ Time Frame: Day 60 ]
    Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
  • Diastolic blood pressure [ Time Frame: Day 2 ]
    Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
  • Diastolic blood pressure [ Time Frame: Day 30 ]
    Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
  • Diastolic blood pressure [ Time Frame: Day 60 ]
    Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
  • Pulse pressure [ Time Frame: Day 2 ]
    Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
  • Pulse pressure [ Time Frame: Day 30 ]
    Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
  • Pulse pressure [ Time Frame: Day 60 ]
    Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
  • SF-36 questionnaire [ Time Frame: Day 2 ]
    Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
  • SF-36 questionnaire [ Time Frame: Day 30 ]
    Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
  • SF-36 questionnaire [ Time Frame: Day 60 ]
    Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 10, 2020)
  • Adverse events [ Time Frame: Day 2 ]
    Evaluation of Adverse events
  • Adverse events [ Time Frame: Day 30 ]
    Evaluation of Adverse events
  • Adverse events [ Time Frame: Day 60 ]
    Evaluation of Adverse events
  • Laboratory parameter (blood chemistry) [ Time Frame: Day 1 ]
    Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study
  • Laboratory parameter (blood chemistry) [ Time Frame: Day 30 ]
    Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study
  • Laboratory parameter (blood chemistry) [ Time Frame: Day 60 ]
    Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study
  • Laboratory parameter (lipid profile) [ Time Frame: Day 1 ]
    Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study
  • Laboratory parameter (lipid profile) [ Time Frame: Day 30 ]
    Evaluation of Laboratory parameter (blood chemistry, lipid profile, LFT and RFT) changes from baseline to end of the study
  • Laboratory parameter (lipid profile) [ Time Frame: Day 60 ]
    Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study
  • Laboratory parameter (LFT ) [ Time Frame: Day 1 ]
    Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study
  • Laboratory parameter (LFT) [ Time Frame: Day 30 ]
    Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study
  • Laboratory parameter (LFT) [ Time Frame: Day 60 ]
    Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study
  • Laboratory parameter (RFT) [ Time Frame: Day 1 ]
    Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study
  • Laboratory parameter (RFT) [ Time Frame: Day 30 ]
    Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study
  • Laboratory parameter (RFT) [ Time Frame: Day 60 ]
    Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study
  • Drop out due to adverse events [ Time Frame: Day 2 ]
    Number of participants that dropout due to adverse events including lab values
  • Drop out due to adverse events [ Time Frame: Day 30 ]
    Number of participants that dropout due to adverse events including lab values
  • Drop out due to adverse events [ Time Frame: Day 60 ]
    Number of participants that dropout due to adverse events including lab values
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: January 10, 2020)
  • BMI [ Time Frame: Day 1 ]
    Monitoring of BMI inter group comparison from baseline to the end of study
  • BMI [ Time Frame: Day 2 ]
    Monitoring of BMI inter group comparison from baseline to the end of study
  • BMI [ Time Frame: Day 30 ]
    Monitoring of BMI inter group comparison from baseline to the end of study
  • BMI [ Time Frame: Day 60 ]
    Monitoring of BMI inter group comparison from baseline to the end of study
  • HOMA [ Time Frame: Day 2 ]
    Monitoring of HOMA inter group comparison from baseline to the end of study
  • HOMA [ Time Frame: Day 60 ]
    Monitoring of HOMA inter group comparison from baseline to the end of study
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3)
Official Title  ICMJE A Multicentre, Randomized, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN), an Orally Administered Supplementation in Middle Aged and Older Adults.
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Masking: Double (Participant, Investigator)
Masking Description:
Randomized, Double-Blind
Primary Purpose: Prevention
Condition  ICMJE Aging
Intervention  ICMJE
  • Other: NMN
    Investigational Product
  • Other: Placebo
    Starch Powder
Study Arms  ICMJE
  • Experimental: Investigational Product
    Ingredient: NMN Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days
    Intervention: Other: NMN
  • Placebo Comparator: Placebo
    Ingredient: Starch powder Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2020)
66
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 30, 2021
Actual Primary Completion Date February 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male/females of 40 to 65 years of age
  2. Body Mass Index (BMI) between 18.5 and 35 kg/m2
  3. Able to provide written Informed Consent
  4. Able to follow verbal and written study directions
  5. Must not be taking or be willing to take any supplements containing any form of niacin for seven days prior to baseline and for the duration of the study.
  6. Able to maintain consistent diet and lifestyle habits throughout the study
  7. Male and female subjects must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study
  8. Willing to consume assigned dietary supplements for 2 months

Exclusion Criteria:

  1. Participants on current use of prescription or over-the-counter nicotinic acid
  2. Use of statin drugs
  3. Having used any tobacco product or used a recreational drug in the past 6 months
  4. Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator
  5. Documented presence of atherosclerotic disease and/or cardiopulmonary disease
  6. History of drug or alcohol abuse
  7. 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. Unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the study start
  9. Participating in or planning to begin a weight loss diet during the study period
  10. Chronic use of over-the-counter medication which would interfere with study endpoints
  11. Lifestyle or schedule incompatible with the study protocol
  12. Known hypersensitivity to the drug components used during the study
  13. Women 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE India
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04228640
Other Study ID Numbers  ICMJE EFFE-CT-01
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party EffePharm LTD
Study Sponsor  ICMJE EffePharm LTD
Collaborators  ICMJE ProRelix Services LLP
Investigators  ICMJE
Principal Investigator: Ganesh Avhad Swasthiye Clinic and Research Center
PRS Account EffePharm LTD
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP