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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- PART II : Telomerase test results
研究概览
简要总结
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)
详细描述
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.
Total number of Subjects is N = 90 (Part 1 & Part 2) Part I: six arms Arm A = 300 mg NMN supplement (n = 20) Arm B = Placebo of 300 mg NMN supplement (n = 07) Arm C = 600 mg NMN supplement (n = 20) Arm D = Placebo of 600 mg NMN supplement (n = 07) Arm E = 900 mg NMN supplement (n = 20) Arm F = Placebo of 900 mg NMN supplement (n = 06) Part II 900 mg NMN supplement (n = 10) Duration of Protocol Therapy = 60 Days Study Population= Middle aged or older male or female subjects (40-65 years)
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 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 will be symptomatically assessed for COVID-19. 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •(Applicable to both parts)
- •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
排除标准
- •(Applicable to both parts).
- •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
- •Unable or unwilling to provide written informed consent for participation in study
研究组 & 干预措施
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.
干预措施: Nicotinamide Mononucleotide (Drug)
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.
干预措施: Placebo (Other)
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.
干预措施: Nicotinamide Mononucleotide (Drug)
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.
干预措施: Placebo (Other)
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.
干预措施: Nicotinamide Mononucleotide (Drug)
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.
干预措施: Placebo (Other)
结局指标
主要结局
PART II : Telomerase test results
时间窗: 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.
PART II : SF-36 questionnaire
时间窗: 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.
Blood cellular NAD+/ NADH
时间窗: 2 month
Blood cellular NAD+ / NADH concentration in serum
Six walking endurance test
时间窗: 2 month
Six minutes walking endurance test
SF-36 questionnaire
时间窗: 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.
次要结局
- safety of NMN(2 Months)
- Tolerability of NMN(2 months)
- Safety of the different NMN doses(2 Months)
- Tolerability different NMN doses(2 Months)
- PART II : Safety of NMN(2 Months)