Status:
COMPLETED
Evaluate the Safety, Tolerability, and Efficacy of UthPeak NMNH (Reduced Nicotinamide Mononucleotide) in Healthy Adult Participants
Lead Sponsor:
EffePharm LTD
Conditions:
Healthy Aging
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
This study is to assess the safety and tolerability of NMNH as a dietary supplement for human consumption. The current study aims to comprehensively evaluate its potential effects on pharmacokinetics,...
Detailed Description
A total of 80 healthy adult participants were considered for enrolment in the study based on predefined eligibility criteria and screening assessments, which included demographics, medical history, cl...
Eligibility Criteria
Inclusion
- Adult healthy male/females aged 40 to 65 years.
- Participants with Body Mass Index (BMI) between 18.5 and 35 kg/m2.
- Participants who are willing to provide written Informed Consent for participating in the study
- Participants who are able to follow verbal and written study directions.
- Participants must be able to maintain consistent diet and lifestyle habits throughout the study.
- Participants must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study.
- Participants willing to administer assigned dietary supplements for 3 months.
Exclusion
- Participants on current use of prescription or over-the-counter nicotinic acid.
- Participants using any statin drugs.
- Participants having used any tobacco product or used a recreational drug in the past 6 months.
- Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator.
- Participants with documented presence of atherosclerotic disease and/or cardiopulmonary disease.
- Participants with history of drug or alcohol abuse.
- Participants with 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.
- Participants unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the start of study.
- Participants who are currently participating in or planning to begin a weight loss diet during the study period.
- Participants who chronically use over-the-counter medication which would interfere with study endpoints.
- Participants whose lifestyle or schedule incompatible with the study protocol.
- Participants with known hypersensitivity to the drug components used during the study.
- Female participants with positive result for urinary beta human chorionic gonadotropin 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.
- Patients with a current diagnosis of any form of cancer within the past 5 years, regardless of disease stage or treatment status, are ineligible for participation in this clinical trial. Any history of cancer within this timeframe must be documented and confirmed through medical records or pathology reports.
Key Trial Info
Start Date :
July 8 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2025
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT06889740
Start Date
July 8 2024
End Date
January 25 2025
Last Update
July 4 2025
Active Locations (2)
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1
Medstar Speciality Hospital
Bengaluru, Karnataka, India, 560092
2
Vinayaka Mission's Medical College and Hospital
Kāraikāl, Puducherry, India, 609609