Status:
COMPLETED
To Evaluate the Efficacy and Safety of NMN as an Anti-ageing Supplement in Middle Aged and Older (40-65 Years) Adults
Lead Sponsor:
Abinopharm, Inc
Collaborating Sponsors:
ProRelix Research
Conditions:
Aging
Eligibility:
All Genders
40-65 years
Phase:
NA
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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- (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
Exclusion
- (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
Key Trial Info
Start Date :
May 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 9 2021
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT04823260
Start Date
May 25 2021
End Date
September 9 2021
Last Update
October 1 2021
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Swasthiya Clinic and Research Center
Pune, Maharashtra, India, 411030
2
Sunad Ayurved
Pune, Maharashtra, India, 411033