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

Aging Clinical Trial

— NMN  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228640
• Other study ID #: EFFE-CT-01
• Status: Completed
• Phase: N/A
• Start date: December 15, 2020
• Est. completion date: March 30, 2021

Study information

• Verified date: March 2021
• Source: EffePharm LTD
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 .

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: March 30, 2021
• Est. primary completion date: February 27, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Aging

Intervention

Other:
• NMN
Investigational Product
• Placebo
Starch Powder

Locations

Country	Name	City	State
India	Dr Kamalakar Gajarae	Pune	Maharashtra
India	Swasthiye Clinic and Research Center	Pune	Maharashtra

Sponsors (2)

Lead Sponsor	Collaborator
EffePharm LTD	ProRelix Services LLP

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	BMI	Monitoring of BMI inter group comparison from baseline to the end of study	Day 1
Other	BMI	Monitoring of BMI inter group comparison from baseline to the end of study	Day 2
Other	BMI	Monitoring of BMI inter group comparison from baseline to the end of study	Day 30
Other	BMI	Monitoring of BMI inter group comparison from baseline to the end of study	Day 60
Other	HOMA	Monitoring of HOMA inter group comparison from baseline to the end of study	Day 2
Other	HOMA	Monitoring of HOMA inter group comparison from baseline to the end of study	Day 60
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Six minutes walking endurance test	Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study	Day 2
Primary	Six minutes walking endurance test	Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study	Day 30
Primary	Six minutes walking endurance test	Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study	Day 60
Primary	Systolic	Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study	Day 2
Primary	Systolic	Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study	Day 30
Primary	Systolic	Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study	Day 60
Primary	Diastolic blood pressure	Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study	Day 2
Primary	Diastolic blood pressure	Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study	Day 30
Primary	Diastolic blood pressure	Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study	Day 60
Primary	Pulse pressure	Evaluation of Pulse Pressure inter group comparison from baseline to the end of study	Day 2
Primary	Pulse pressure	Evaluation of Pulse Pressure inter group comparison from baseline to the end of study	Day 30
Primary	Pulse pressure	Evaluation of Pulse Pressure inter group comparison from baseline to the end of study	Day 60
Primary	SF-36 questionnaire	Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study	Day 2
Primary	SF-36 questionnaire	Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study	Day 30
Primary	SF-36 questionnaire	Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study	Day 60
Secondary	Adverse events	Evaluation of Adverse events	Day 2
Secondary	Adverse events	Evaluation of Adverse events	Day 30
Secondary	Adverse events	Evaluation of Adverse events	Day 60
Secondary	Laboratory parameter (blood chemistry)	Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study	Day 1
Secondary	Laboratory parameter (blood chemistry)	Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study	Day 30
Secondary	Laboratory parameter (blood chemistry)	Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study	Day 60
Secondary	Laboratory parameter (lipid profile)	Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study	Day 1
Secondary	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
Secondary	Laboratory parameter (lipid profile)	Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study	Day 60
Secondary	Laboratory parameter (LFT )	Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study	Day 1
Secondary	Laboratory parameter (LFT)	Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study	Day 30
Secondary	Laboratory parameter (LFT)	Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study	Day 60
Secondary	Laboratory parameter (RFT)	Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study	Day 1
Secondary	Laboratory parameter (RFT)	Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study	Day 30
Secondary	Laboratory parameter (RFT)	Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study	Day 60
Secondary	Drop out due to adverse events	Number of participants that dropout due to adverse events including lab values	Day 2
Secondary	Drop out due to adverse events	Number of participants that dropout due to adverse events including lab values	Day 30
Secondary	Drop out due to adverse events	Number of participants that dropout due to adverse events including lab values	Day 60