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Search / Trial NCT06889740

Evaluate the Safety, Tolerability, and Efficacy of UthPeak NMNH (Reduced Nicotinamide Mononucleotide) in Healthy Adult Participants

Launched by EFFEPHARM LTD · Mar 20, 2025

Trial Information

Current as of April 30, 2025

Completed

Keywords

Uth Peak Nmnh Reduced Nmn Reduced Nicotinamide Mononucleotide

ClinConnect Summary

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, clinical laboratory tests, diagnostic evaluations, and prior medication review.

The 80 participants were randomly assigned to placebo group, NMNH 125 mg group, NMNH 250 mg group, or NMNH 500 mg group, and oral supplementation for 90 consecutive days.

Baseline assessments comprised NAD+ levels, BMI, biological age evaluation, a six-minute walking test, and a quality-of-life assessment. These par...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. Adult healthy male/females aged 40 to 65 years.
  • 2. Participants with Body Mass Index (BMI) between 18.5 and 35 kg/m2.
  • 3. Participants who are willing to provide written Informed Consent for participating in the study
  • 4. Participants who are able to follow verbal and written study directions.
  • 5. Participants must be able to maintain consistent diet and lifestyle habits throughout the study.
  • 6. Participants must be willing to agree to use effective contraceptive methods while on treatment and for 3 months after the completion of study.
  • 7. Participants willing to administer assigned dietary supplements for 3 months.
  • Exclusion Criteria:
  • 1. Participants on current use of prescription or over-the-counter nicotinic acid.
  • 2. Participants using any statin drugs.
  • 3. Participants having used any tobacco product or used a recreational drug in the past 6 months.
  • 4. Participants having abnormal screening laboratory test values or other lab test result(s) that would preclude study participation in the judgment of the investigator.
  • 5. Participants with documented presence of atherosclerotic disease and/or cardiopulmonary disease.
  • 6. Participants with history of drug or alcohol abuse.
  • 7. 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.
  • 8. Participants unwilling to discontinue use of conventional multivitamin/mineral or other supplements at least two weeks prior to the start of study.
  • 9. Participants who are currently participating in or planning to begin a weight loss diet during the study period.
  • 10. Participants who chronically use over-the-counter medication which would interfere with study endpoints.
  • 11. Participants whose lifestyle or schedule incompatible with the study protocol.
  • 12. Participants with known hypersensitivity to the drug components used during the study.
  • 13. Female participants 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.
  • 18. 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.

About Effepharm Ltd

Effepharm Ltd. is a dynamic clinical research organization dedicated to advancing innovative therapeutic solutions in the pharmaceutical industry. With a focus on precision medicine, the company specializes in the development and execution of clinical trials that adhere to the highest standards of scientific rigor and ethical integrity. Effepharm Ltd. leverages a collaborative approach, working closely with regulatory bodies, healthcare professionals, and patients to ensure robust data collection and analysis. Committed to enhancing patient outcomes, Effepharm Ltd. strives to bring groundbreaking therapies to market that address unmet medical needs across various therapeutic areas.

Locations

Bengaluru, Karnataka, India

Karaikal, Puducherry, India

Patients applied

0 patients applied

Trial Officials

Chikkalingaiah Siddegowda

Study Director

Medstar Specialist Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported