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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04823260
Recruitment Status : Completed
First Posted : March 30, 2021
Last Update Posted : October 1, 2021
Sponsor:
Collaborator:
ProRelix Services LLP
Information provided by (Responsible Party):
Abinopharm, Inc

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)


Condition or disease Intervention/treatment Phase
Aging Drug: Nicotinamide Mononucleotide Other: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: A Multi Center Two Part Study to Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults
Actual Study Start Date : May 25, 2021
Actual Primary Completion Date : September 9, 2021
Actual Study Completion Date : September 9, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Drug: Nicotinamide Mononucleotide
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

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.
Other: Placebo
Rice flour in white capsule resembling NMN

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.
Drug: Nicotinamide Mononucleotide
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

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.
Other: Placebo
Rice flour in white capsule resembling NMN

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.
Drug: Nicotinamide Mononucleotide
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

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.
Other: Placebo
Rice flour in white capsule resembling NMN




Primary Outcome Measures :
  1. Blood cellular NAD+/ NADH [ Time Frame: Baseline ]
    Blood cellular NAD+ / NADH concentration in serum

  2. Blood cellular NAD+/ NADH [ Time Frame: 1 month ]
    Blood cellular NAD+ / NADH concentration in serum

  3. Blood cellular NAD+/ NADH [ Time Frame: 2 month ]
    Blood cellular NAD+ / NADH concentration in serum

  4. Six walking endurance test [ Time Frame: Baseline ]
    Six minutes walking endurance test

  5. Six walking endurance test [ Time Frame: 1 month ]
    Six minutes walking endurance test

  6. Six walking endurance test [ Time Frame: 2 month ]
    Six minutes walking endurance test

  7. SF-36 questionnaire [ Time Frame: Baseline ]
    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.

  8. SF-36 questionnaire [ Time Frame: 1 month ]
    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.

  9. SF-36 questionnaire [ Time Frame: 2 month ]
    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.

  10. PART II : Telomerase test results [ Time Frame: Baseline ]
    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.

  11. PART II : Telomerase test results [ Time Frame: 2 Months ]
    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.

  12. PART II : SF-36 questionnaire [ Time Frame: Baseline ]
    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.

  13. PART II : SF-36 questionnaire [ Time Frame: 2 months ]
    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 Outcome Measures :
  1. safety of NMN [ Time Frame: Baseline ]
    To compare the safety of NMN versus placebo

  2. safety of NMN [ Time Frame: 2 Months ]
    Monitoring and documentation of number and types of adverse events including changes on laboratory parameter (blood chemistry, lipid profile, LFT and RFT)

  3. Tolerability of NMN [ Time Frame: Baseline ]
    Number of participants that drop out due to adverse events including lab values. Monitoring ad documentation of subject drop out due to adverse events.

  4. Tolerability of NMN [ Time Frame: 2 months ]
    Number of participants that drop out due to adverse events including lab values. Monitoring ad documentation of subject drop out due to adverse events.

  5. Safety of the different NMN doses [ Time Frame: 2 Months ]
    Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT)

  6. Tolerability different NMN doses [ Time Frame: Baseline ]
    Number of participants that drop out due to adverse events including lab values

  7. Tolerability different NMN doses [ Time Frame: 2 Months ]
    Number of participants that drop out due to adverse events including lab values

  8. PART II : Safety of NMN [ Time Frame: Baseline ]
    Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT)

  9. PART II : Safety of NMN [ Time Frame: 2 Months ]
    Monitoring and documentation of number and types of adverse events including changes in lab parameter (blood chemistry, lipid profile, LFT, RFT)


Other Outcome Measures:
  1. BMI [ Time Frame: Baseline ]
    Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.

  2. BMI [ Time Frame: 2 months ]
    Body Mass Index (BMI) is a person's weight in kilograms divided by the square of height in meters. A high BMI can be an indicator of high body fatness.

  3. HOMA (Homeostatic model assessment) [ Time Frame: Baseline ]
    Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.

  4. HOMA (Homeostatic model assessment) [ Time Frame: 2 months ]
    Homeostatic model assessment (HOMA) is a method for assessing β-cell function and insulin resistance (IR) from basal (fasting) glucose and insulin or C-peptide concentrations.

  5. Biological Age using Aging.Ai 3.0 calculator [ Time Frame: Baseline ]
    Biological age, also referred to as physiological age, takes many lifestyle factors into consideration, including diet, exercise and sleeping habits, to name a few.

  6. Biological Age using Aging.Ai 3.0 calculator [ Time Frame: 2 Months ]
    Biological age, also referred to as physiological age, takes many lifestyle factors into consideration, including diet, exercise and sleeping habits, to name a few.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04823260


Locations
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India
Swasthiya Clinic and Research Center
Pune, Maharashtra, India, 411030
Sunad Ayurved
Pune, Maharashtra, India, 411033
Sponsors and Collaborators
Abinopharm, Inc
ProRelix Services LLP
Investigators
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Study Chair: Mr.Lin Yi Abinopharm, Inc
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Responsible Party: Abinopharm, Inc
ClinicalTrials.gov Identifier: NCT04823260    
Other Study ID Numbers: AP-NMN-CT01-21
First Posted: March 30, 2021    Key Record Dates
Last Update Posted: October 1, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Abinopharm, Inc:
Nicotinamide Mononucleotide (NMN)
Anti Ageing
Telomerase
Additional relevant MeSH terms:
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Niacinamide
Niacin
Nicotinic Acids
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Vasodilator Agents