To Evaluate the Efficacy and Safety of vitamin NMN in Middle Aged and Older Adults for Anti-aging and Work-Out Enhancer
- Registration Number
- CTRI/2019/12/022514
- Lead Sponsor
- Effepharm Shanghai Co Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 66
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
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 participantâ??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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the efficacy of Uthever NMN supplementation in terms of stimulation of NAD+ metabolismTimepoint: To compare the efficacy of Uthever NMN supplementation in terms of stimulation of NAD+ metabolism
- Secondary Outcome Measures
Name Time Method To assess and compare the safety and tolerability of the formulationTimepoint: Visit 1, visit 2, visit 3, visit 4