Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3)

NCT04228640 | Completed

• 1 other identifier: EFFE-CT-01
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

This will be a multi-center, two arm study in 66 healthy adults. Subjects will complete a screening visit (V1, Day -7) to determine eligibility for the study based on Inclusion \& Exclusion Criteria, patient history and safety measures. Eligibility confirmation will be done on visit 2 (Day 1). Patients successfully completing screen will be assigned to either of the two treatments. Subjects will receive the treatment for at-home use and will also be given diaries for recording information of medication, and adverse events. At 2 different intervals i.e. Day 30 and Day 60 (V3, V4) subjects will return to the clinic to review and collect patient diaries, safety data and medication reconciliation. Efficacy and safety assessments will be done at baseline, Day 30 and Day 60 .

Conditions

Aging

Keywords

Anti- Aging; Workout Enhancer

Outcome Measures

Primary Outcomes (21)

• Blood cellular NAD+ concentration in serum

  Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study

  Day 2

• Blood cellular NAD+ concentration in serum

  Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study

  Day 30

• Blood cellular NAD+ concentration in serum

  Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study

  Day 60

• Blood cellular NADH concentration in serum

  Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study

  Day 2

• Blood cellular NADH concentration in serum

  Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study

  Day 30

• Blood cellular NADH concentration in serum

  Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study

  Day 60

• Six minutes walking endurance test

  Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study

  Day 2

• Six minutes walking endurance test

  Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study

  Day 30

• Six minutes walking endurance test

  Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study

  Day 60

• Systolic

  Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study

  Day 2

• Systolic

  Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study

  Day 30

• Systolic

  Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study

  Day 60

• Diastolic blood pressure

  Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study

  Day 2

• Diastolic blood pressure

  Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study

  Day 30

• Diastolic blood pressure

  Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study

  Day 60

• Pulse pressure

  Evaluation of Pulse Pressure inter group comparison from baseline to the end of study

  Day 2

• Pulse pressure

  Evaluation of Pulse Pressure inter group comparison from baseline to the end of study

  Day 30

• Pulse pressure

  Evaluation of Pulse Pressure inter group comparison from baseline to the end of study

  Day 60

• SF-36 questionnaire

  Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study

  Day 2

• SF-36 questionnaire

  Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study

  Day 30

• SF-36 questionnaire

  Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study

  Day 60

Secondary Outcomes (18)

• Adverse events

  Day 2

• Adverse events

  Day 30

• Adverse events

  Day 60

• Laboratory parameter (blood chemistry)

  Day 1

• Laboratory parameter (blood chemistry)

  Day 30

Other Outcomes (6)

• BMI

  Day 1

• BMI

  Day 2

• BMI

  Day 30

Study Arms (2)

Investigational Product

EXPERIMENTAL

Ingredient: NMN Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days

Other: NMN

Placebo

PLACEBO COMPARATOR

Ingredient: Starch powder Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days

Other: Placebo

Interventions

NMN OTHER

Investigational Product

Investigational Product

Placebo OTHER

Starch Powder

Placebo

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 dietary supplements for 2 months

You may not qualify if:

• 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
• Chronic use of over-the-counter medication which would interfere with study endpoints
• Lifestyle or schedule incompatible with the study protocol
• Known hypersensitivity to the drug components used during the study
• Women 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

Sponsors & Collaborators

• EffePharm LTD: lead
• ProRelix Research: collaborator

Study Sites (2)

Dr Kamalakar Gajarae

Pune, Maharashtra, 411019, India

Location

Swasthiye Clinic and Research Center

Pune, Maharashtra, 411030, India

Location

Related Publications (1)

• Huang H. A Multicentre, Randomised, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN Supplement), an Orally Administered Supplementation in Middle Aged and Older Adults. Front Aging. 2022 May 5;3:851698. doi: 10.3389/fragi.2022.851698. eCollection 2022.

  PMID: 35821806 DERIVED

Study Officials

• Ganesh Avhad

  Swasthiye Clinic and Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized, Double-Blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A Multicenter, Randomized, Double-Blind, Placebo-Controlled

Study Record Dates

• First Submitted: January 9, 2020
• First Posted: January 14, 2020
• Study Start: December 15, 2020
• Primary Completion: February 27, 2021
• Study Completion: March 30, 2021
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IN (2)