Clinical trial NCT04228640: Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: Anti- Aging
Workout Enhancer
Lead sponsor: EffePharm LTD
Sponsor class: INDUSTRY
Collaborators: name: ProRelix Research
First posted: 2020-01-14
Enrollment: 66
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Multicenter, Randomized, Double-Blind, Placebo-Controlled
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Blood cellular NAD+ concentration in serum
timeFrame: Day 2
measure: Blood cellular NAD+ concentration in serum
timeFrame: Day 30
measure: Blood cellular NAD+ concentration in serum
timeFrame: Day 60
measure: Blood cellular NADH concentration in serum
timeFrame: Day 2
measure: Blood cellular NADH concentration in serum
timeFrame: Day 30
measure: Blood cellular NADH concentration in serum
timeFrame: Day 60
measure: Six minutes walking endurance test
timeFrame: Day 2
measure: Six minutes walking endurance test
timeFrame: Day 30
measure: Six minutes walking endurance test
timeFrame: Day 60
measure: Systolic
timeFrame: Day 2
measure: Systolic
timeFrame: Day 30
measure: Systolic
timeFrame: Day 60
measure: Diastolic blood pressure
timeFrame: Day 2
measure: Diastolic blood pressure
timeFrame: Day 30
measure: Diastolic blood pressure
timeFrame: Day 60
measure: Pulse pressure
timeFrame: Day 2
measure: Pulse pressure
timeFrame: Day 30
measure: Pulse pressure
timeFrame: Day 60
measure: SF-36 questionnaire
timeFrame: Day 2
measure: SF-36 questionnaire
timeFrame: Day 30
measure: SF-36 questionnaire
timeFrame: Day 60
Secondary outcomes:
measure: Adverse events
timeFrame: Day 2
measure: Adverse events
timeFrame: Day 30
measure: Adverse events
timeFrame: Day 60
measure: Laboratory parameter (blood chemistry)
timeFrame: Day 1
measure: Laboratory parameter (blood chemistry)
timeFrame: Day 30
measure: Laboratory parameter (blood chemistry)
timeFrame: Day 60
measure: Laboratory parameter (lipid profile)
timeFrame: Day 1
measure: Laboratory parameter (lipid profile)
timeFrame: Day 30
measure: Laboratory parameter (lipid profile)
timeFrame: Day 60
measure: Laboratory parameter (LFT )
timeFrame: Day 1
measure: Laboratory parameter (LFT)
timeFrame: Day 30
measure: Laboratory parameter (LFT)
timeFrame: Day 60
measure: Laboratory parameter (RFT)
timeFrame: Day 1
measure: Laboratory parameter (RFT)
timeFrame: Day 30
measure: Laboratory parameter (RFT)
timeFrame: Day 60
measure: Drop out due to adverse events
timeFrame: Day 2
measure: Drop out due to adverse events
timeFrame: Day 30
measure: Drop out due to adverse events
timeFrame: Day 60
Other outcomes:
measure: BMI
timeFrame: Day 1
measure: BMI
timeFrame: Day 2
measure: BMI
timeFrame: Day 30
measure: BMI
timeFrame: Day 60
measure: HOMA
timeFrame: Day 2
measure: HOMA
timeFrame: Day 60
Locations:
city: Pune
country: India
facility: Dr Kamalakar Gajarae
state: Maharashtra
city: Pune
country: India
facility: Swasthiye Clinic and Research Center
state: Maharashtra
Study officials:
affiliation: Swasthiye Clinic and Research Center
name: Ganesh Avhad
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.