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

NCT04823260 | Completed

• 1 other identifier: AP-NMN-CT01-21
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

Brief Summary

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)

Conditions

Aging

Keywords

Nicotinamide Mononucleotide (NMN); Anti Ageing; Telomerase

Outcome Measures

Primary Outcomes (13)

• Blood cellular NAD+/ NADH

  Blood cellular NAD+ / NADH concentration in serum

  Baseline

• Blood cellular NAD+/ NADH

  Blood cellular NAD+ / NADH concentration in serum

  1 month

• Blood cellular NAD+/ NADH

  Blood cellular NAD+ / NADH concentration in serum

  2 month

• Six walking endurance test

  Six minutes walking endurance test

  Baseline

• Six walking endurance test

  Six minutes walking endurance test

  1 month

• Six walking endurance test

  Six minutes walking endurance test

  2 month

• SF-36 questionnaire

  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.

  Baseline

• SF-36 questionnaire

  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.

  1 month

• SF-36 questionnaire

  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.

  2 month

• PART II : Telomerase test results

  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.

  Baseline

• PART II : Telomerase test results

  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.

  2 Months

• PART II : SF-36 questionnaire

  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.

  Baseline

• PART II : SF-36 questionnaire

  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.

  2 months

Secondary Outcomes (9)

• safety of NMN

  Baseline

• safety of NMN

  2 Months

• Tolerability of NMN

  Baseline

• Tolerability of NMN

  2 months

• Safety of the different NMN doses

  2 Months

Other Outcomes (6)

• BMI

  Baseline

• BMI

  2 months

• HOMA (Homeostatic model assessment)

  Baseline

Study Arms (6)

Arm A = 300 mg NMN supplement (n = 20)

ACTIVE COMPARATOR

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.

Drug: Nicotinamide Mononucleotide

Arm B = Placebo 300 mg (n=07)

PLACEBO COMPARATOR

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.

Other: Placebo

Arm C = NMN Supplement 600 mg (n= 20)

ACTIVE COMPARATOR

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.

Drug: Nicotinamide Mononucleotide

Arm D = Placebo 600 mg (n=07)

PLACEBO COMPARATOR

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.

Other: Placebo

Arm E = NMN Supplement 900 mg (n=10)

ACTIVE COMPARATOR

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.

Drug: Nicotinamide Mononucleotide

Arm F = Placebo 900 mg (n=06)

PLACEBO COMPARATOR

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.

Other: Placebo

Interventions

Nicotinamide Mononucleotide DRUG

Nicotinamide adenine dinucleotide (NAD+) is an essential cofactor in all living cells involved in fundamental biological processes. Depletion in the levels of NAD+ is associated with traits of aging, many age-related diseases like cancer, metabolic disorders and neurological disorders. Evidence stemming from recent studies have unveiled numerous roles of NAD+ metabolism on aging and longevity and delaying the progression of age-related diseases

Arm A = 300 mg NMN supplement (n = 20); Arm C = NMN Supplement 600 mg (n= 20); Arm E = NMN Supplement 900 mg (n=10)

Placebo OTHER

Rice flour in white capsule resembling NMN

Arm B = Placebo 300 mg (n=07); Arm D = Placebo 600 mg (n=07); Arm F = Placebo 900 mg (n=06)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male/females of 40 to 65 years of age
• Body Mass Index (BMI) between 18.5 and 35 kg/m2
• Able to provide written Informed Consent
• Able to follow verbal and written study directions
• 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.
• Able to maintain consistent diet and lifestyle habits throughout the study
• 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
• Willing to consume assigned supplement (NMN or placebo) for 2 months

You may not qualify if:

• Participants on current use of prescription or over-the-counter nicotinic acid
• Use of statin drugs
• Having used any tobacco product or used a recreational drug in the past 6 months
• Having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator
• Documented presence of atherosclerotic disease and/or cardiopulmonary disease
• History of drug or alcohol abuse
• 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
• Unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the study start
• Participating in or planning to begin a weight loss diet during the study period,
• Lifestyle or schedule incompatible with the study protocol
• Known hypersensitivity to any form of niacin used during the study
• Women with positive result for Urine Pregnancy Test or gestation period or breastfeeding
• 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.
• Currently, or within the past 30 days, enrolled in a different clinical investigation
• Inability to provide a venous blood sample

Sponsors & Collaborators

• Abinopharm, Inc: lead
• ProRelix Research: collaborator

Study Sites (2)

Swasthiya Clinic and Research Center

Pune, Maharashtra, 411030, India

Location

Sunad Ayurved

Pune, Maharashtra, 411033, India

Location

Related Publications (1)

• Yi L, Maier AB, Tao R, Lin Z, Vaidya A, Pendse S, Thasma S, Andhalkar N, Avhad G, Kumbhar V. The efficacy and safety of beta-nicotinamide mononucleotide (NMN) supplementation in healthy middle-aged adults: a randomized, multicenter, double-blind, placebo-controlled, parallel-group, dose-dependent clinical trial. Geroscience. 2023 Feb;45(1):29-43. doi: 10.1007/s11357-022-00705-1. Epub 2022 Dec 8.

  PMID: 36482258 DERIVED

MeSH Terms

Interventions

Nicotinamide Mononucleotide

Intervention Hierarchy (Ancestors)

Ribonucleotides; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Mr.Lin Yi

  Abinopharm, Inc

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2021
• First Posted: March 30, 2021
• Study Start: May 25, 2021
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: October 1, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)