Trial · Interventional

CompletedNot applicableRegistry data

To Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults

NCTNCT04823260Other idAP-NMN-CT01-21

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Not applicable
Enrollment: 90 participants (actual)
Sponsor: Abinopharm, Inc · Network
Design: Randomized · Quadruple masking
Countries: 1 country
India
Start: 25 May 2021
Primary completion: 9 Sept 2021
Completion: 9 Sept 2021
First posted: 30 Mar 2021
Last update posted: 1 Oct 2021
Conditions: Aging

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20212022

N/A
To Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults
NCT04823260
25 May 2021 to 9 Sept 2021

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

It will be a two-part study. Part I will be six arms; randomized, double blind, parallel design, placebo-controlled dose ranging study. Part II will be open-label single dose study at the highest dose. A total of 90 Subjects (Part 1 \& Part 2) will be enrolled in the study. The Part 1 group subjects (80 Subjects) shall be randomly distributed between the six arms, i.e. 20 Subjects each in IP arms, and 7, 7 and 6 subjects in corresponding placebo arms. All Part 2 Group subjects (10 Subjects) will be assigned into the cluster where all receive the maximum NMN dose (900 mg)

Interventions

Nicotinamide MononucleotideDrug
PlaceboOther

Arms6

Active comparator
Arm A = 300 mg NMN supplement (n = 20)
Subjects who are assigned to 300 mg arm (NMN) will be instructed to take 2 capsules after breakfast once a day with ambient temperature water for 60 days.
Placebo comparator
Arm B = Placebo 300 mg (n=07)
Subjects who are assigned to 300 mg arm (placebo) will be instructed to take 2 capsules after breakfast once a day with ambient temperature water for 60 days.
Active comparator
Arm C = NMN Supplement 600 mg (n= 20)
Subjects who are assigned to 600 mg arm (NMN) will be instructed to take 4 capsules after breakfast once a day with ambient temperature water for 60 days.
Placebo comparator
Arm D = Placebo 600 mg (n=07)
Subjects who are assigned to 600 mg arm (Placebo) will be instructed to take 4 capsules after breakfast once a day with ambient temperature water for 60 days.
Active comparator
Arm E = NMN Supplement 900 mg (n=10)
Subjects who are assigned to 900 mg arm (NMN) will be instructed to take 6 capsules after breakfast once a day with ambient temperature water for 60 days.
Placebo comparator
Arm F = Placebo 900 mg (n=06)
Subjects who are assigned to 900 mg arm (Placebo) will be instructed to take 6 capsules after breakfast once a day with ambient temperature water for 60 days.

Primary outcomes13

Outcomes the sponsor listed as primary.

Blood cellular NAD+/ NADH
Time frame · Baseline
Registry description
Blood cellular NAD+ / NADH concentration in serum
Blood cellular NAD+/ NADH
Time frame · 1 month
Registry description
Blood cellular NAD+ / NADH concentration in serum
Blood cellular NAD+/ NADH
Time frame · 2 month
Registry description
Blood cellular NAD+ / NADH concentration in serum
Six walking endurance test
Time frame · Baseline
Registry description
Six minutes walking endurance test
Six walking endurance test
Time frame · 1 month
Registry description
Six minutes walking endurance test
Six walking endurance test
Time frame · 2 month
Registry description
Six minutes walking endurance test
SF-36 questionnaire
Time frame · Baseline
Registry description
Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study.
SF-36 questionnaire
Time frame · 1 month
Registry description
Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study.
SF-36 questionnaire
Time frame · 2 month
Registry description
Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study.
PART II : Telomerase test results
Time frame · Baseline
Registry description
Telomere are repetitive nucleotide elements at the end of chromosomes that protect chromosomes from degradation and genetic information loss.In this study we will be doing absolute Human telomere length quantification qPCR assay using a RUO commercial kit. The method uses delta Cq method for calculating relative telomere length with reference DNA used.
PART II : Telomerase test results
Time frame · 2 Months
Registry description
Telomere are repetitive nucleotide elements at the end of chromosomes that protect chromosomes from degradation and genetic information loss.In this study we will be doing absolute Human telomere length quantification qPCR assay using a RUO commercial kit. The method uses delta Cq method for calculating relative telomere length with reference DNA used.
PART II : SF-36 questionnaire
Time frame · Baseline
Registry description
Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study.
PART II : SF-36 questionnaire
Time frame · 2 months
Registry description
Short Form-36 questionnaire is a general health questionnaire consisting of 36 questions. The quality of life among the study participants using questionnaire by comparing with end of study.

Secondary outcomes(9)

safety of NMN
Time frame · Baseline
Registry description
To compare the safety of NMN versus placebo
safety of NMN
Time frame · 2 Months
Registry description
Monitoring and documentation of number and types of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT)
Tolerability of NMN
Time frame · Baseline
Registry description
Number of participants that drop out due to adverse events including lab values. Monitoring ad documentation of subject drop out due to adverse events.
Tolerability of NMN
Time frame · 2 months
Registry description
Number of participants that drop out due to adverse events including lab values. Monitoring ad documentation of subject drop out due to adverse events.
Safety of the different NMN doses
Time frame · 2 Months
Registry description
Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT)
Tolerability different NMN doses
Time frame · Baseline
Registry description
Number of participants that drop out due to adverse events including lab values
Tolerability different NMN doses
Time frame · 2 Months
Registry description
Number of participants that drop out due to adverse events including lab values
PART II : Safety of NMN
Time frame · Baseline
Registry description
Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT)
PART II : Safety of NMN
Time frame · 2 Months
Registry description
Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT)

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2023

8 results

The efficacy and safety of β-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial.

Yi et al. 2023GeroSciencecited by 139

PMID 36482258PMC9735188DOI 10.1007/s11357-022-00705-1PUB-36482258

CC BY8 results

Download PDF See results (8)

Eligibility

Who could join, as posted.

Sex: All
Age: from 40 Years up to 65 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: (Applicable to both parts) 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 supplement (NMN or placebo) for 2 months Exclusion Criteria: (Applicable to both parts). 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. Lifestyle or schedule incompatible with the study protocol 11. Known hypersensitivity to any form of niacin used during the study 12. Women with positive result for Urine Pregnancy Test or gestation period or breastfeeding 13. 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. 14. Currently, or within the past 30 days, enrolled in a different clinical investigation 15. Inability to provide a venous blood sample 16. Unable or unwilling to provide written informed consent for participation in study

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