AgingNMNNCT04228640
Evaluate the Efficacy and Safety of Uthever NMN(Nicotinamide Mononucleotide, a Form of Vitamin B3)
A study testing NMN in people with Aging, run by EffePharm LTD at 2 sites in India.
Trial 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). Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- NMN
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 66 participants
- Where
- 2 sitesIndia
- Study dates
- 15 Dec 2020to 30 Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 17Show fewer
- 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
- Inability to provide a venous blood sample
- Unable or unwilling to provide written informed consent for participation in study
Trial locations and contacts
2 sites in 1 country.
India2 sites
Dr Kamalakar Gajarae
Pune, Maharashtra, 411019
Swasthiye Clinic and Research Center
Pune, Maharashtra, 411030
About this study
Official title: A Multicentre, Randomized, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN), an Orally Administered Supplementation in Middle Aged and Older Adults.
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 .
Read the detailed description
Sixty-six healthy male or female middle-aged or older subjects will be assigned in 1:1 ratio to treatment with the test product, NMN or Placebo in this double-blind, randomized, placebo-controlled study. All 66 enrolled subjects will be instructed to take two capsules of either NMN or Placebo once a day after breakfast for 60 days daily. Subjects will be required to use diaries to document the date and time of study treatments including any missed doses and the occurrence of any adverse events.
The duration of each subject's participation in the study will be of 60 days.
Scheduled study visits will include:
- Visit 1 (Screening, Day -4)
- Visit 2 (Baseline/Randomization visit, Day 1)
- Visit 3 (Day 30).
- Visit 4 (End of study, Day 60) A window (± 2 days) will be considered acceptable for each scheduled visit following the baseline visit.
During Visit 1 (Screening), informed consent will be obtained before any study procedures take place. After subject has been consented, medical history will then be documented, including the concomitant medications (if any). Physical examination and ECG will be carried out for all subjects. Subjects' vital signs will be recorded along with pulse pressure (PP).Their laboratory investigations like Hematology, Clinical chemistry and Urinalysis will be done. They shall undergo the screening procedure by inclusion and exclusion criteria. Subject's demography data will be collected. They will be given instructions for the next visit.
At Visit 2 (Day 1, Baseline visit), eligibility confirmation will be done, and each enrolled subject will be randomly assigned in double-blind fashion, in 1:1 ratio to the test product or the Placebo. Blinded investigational product will be dispensed to subjects who meet all the inclusion and none of the exclusion criteria. Subjects will be instructed to take two capsules of the either placebo or NMN once a day with ambient temperature water after breakfast. They shall be recording the dosing details in subject diaries. The first dose of Investigational Product will be taken by the subject at home. Subjects will be evaluated through SF-36 questionnaire for their health. They will be required to answer few questions pertaining to their health. (PI, CRC or site staff will fill SF-36 questionnaire in visit 2, 3 and 4 by asking the subject). All the baseline assessments for efficacy will be performed.
At visit 3 (Day 30) and visit 4 (Day 60), subjects will return to the clinic to review and collect subjects' diaries, safety data, and medication reconciliation. Efficacy and safety assessments will be done at both the visits.
Subjects will be asked to bring their subject diaries and used/unused Investigational Products every time they visit the site. Enough quantity of Investigational Product will be dispensed every visit. Subjects' vital signs will be recorded along with pulse pressure (PP) at all visits. Adverse event assessment and concomitant assessment will be done at each visit along with compliance with drug applications.
- Conditions
- Aging
- Being tested
- NMN, Placebo
- Keywords
- Anti- Aging, Workout Enhancer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMNOther
Investigational Product
PlaceboOther
Starch Powder
| Study group | Role | What they receive |
|---|---|---|
| Investigational Product | Experimental | Ingredient: NMN Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days Receives: Other: NMN |
| Placebo | Placebo comparator | Ingredient: Starch powder Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood cellular NAD+ concentration in serum
Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Day 60
Six minutes walking endurance test
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
Measured: Day 2
Six minutes walking endurance test
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
Measured: Day 30
Six minutes walking endurance test
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
Measured: Day 60
Systolic
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
Measured: Day 2
Systolic
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
Measured: Day 30
Systolic
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
Measured: Day 60
Diastolic blood pressure
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
Measured: Day 2
Diastolic blood pressure
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
Measured: Day 30
Diastolic blood pressure
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
Measured: Day 60
Pulse pressure
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
Measured: Day 2
Pulse pressure
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
Measured: Day 30
Pulse pressure
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
Measured: Day 60
SF-36 questionnaire
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
Measured: Day 2
SF-36 questionnaire
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
Measured: Day 30
SF-36 questionnaire
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
Measured: Day 60
Secondary outcomes (18)
Adverse events
Evaluation of Adverse events
Measured: Day 2
Adverse events
Evaluation of Adverse events
Measured: Day 30
Adverse events
Evaluation of Adverse events
Measured: Day 60
Laboratory parameter (blood chemistry)
Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study
Measured: Day 1
Laboratory parameter (blood chemistry)
Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study
Measured: Day 30
Laboratory parameter (blood chemistry)
Evaluation of Laboratory parameter (blood chemistry) changes from baseline to end of the study
Measured: Day 60
Laboratory parameter (lipid profile)
Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study
Measured: Day 1
Laboratory parameter (lipid profile)
Evaluation of Laboratory parameter (blood chemistry, lipid profile, LFT and RFT) changes from baseline to end of the study
Measured: Day 30
Laboratory parameter (lipid profile)
Evaluation of Laboratory parameter (lipid profile) changes from baseline to end of the study
Measured: Day 60
Laboratory parameter (LFT )
Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study
Measured: Day 1
Laboratory parameter (LFT)
Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study
Measured: Day 30
Laboratory parameter (LFT)
Evaluation of Laboratory parameter (LFT ) changes from baseline to end of the study
Measured: Day 60
Laboratory parameter (RFT)
Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study
Measured: Day 1
Laboratory parameter (RFT)
Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study
Measured: Day 30
Laboratory parameter (RFT)
Evaluation of Laboratory parameter (RFT) changes from baseline to end of the study
Measured: Day 60
Drop out due to adverse events
Number of participants that dropout due to adverse events including lab values
Measured: Day 2
Drop out due to adverse events
Number of participants that dropout due to adverse events including lab values
Measured: Day 30
Drop out due to adverse events
Number of participants that dropout due to adverse events including lab values
Measured: Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2020
- Study start15 Dec 2020
- Primary completion27 Feb 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- EffePharm LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ProRelix Research
- Responsible party
- Sponsor
- Investigators
- Ganesh Avhad, Principal investigator, Swasthiye Clinic and Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04228640
- Sponsor's protocol ID
- EFFE-CT-01
- Acronym
- NMN
- Status last verified
- Mar 2021
- First submitted
- 9 Jan 2020
- Last updated
- 1 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35821806
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Randomized, Double Blind, Parallel Design, Placebo Controlled Study to Evaluate the Efficacy and Safety of Uthever (NMN), an Orally Administered Supplementation in Middle Aged and Older Adults.
- ClinicalTrials.gov ID
- NCT04228640
- Acronym / sponsor ID
- NMN / EFFE-CT-01
- Conditions
- Aging
- Keywords
- Anti- Aging, Workout Enhancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- EffePharm LTDIndustry (pharma, biotech, devices)
- Collaborators
- ProRelix Research
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 27 Feb 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
Detailed description
Sixty-six healthy male or female middle-aged or older subjects will be assigned in 1:1 ratio to treatment with the test product, NMN or Placebo in this double-blind, randomized, placebo-controlled study. All 66 enrolled subjects will be instructed to take two capsules of either NMN or Placebo once a day after breakfast for 60 days daily. Subjects will be required to use diaries to document the date and time of study treatments including any missed doses and the occurrence of any adverse events.
The duration of each subject's participation in the study will be of 60 days.
Scheduled study visits will include:
- Visit 1 (Screening, Day -4)
- Visit 2 (Baseline/Randomization visit, Day 1)
- Visit 3 (Day 30).
- Visit 4 (End of study, Day 60) A window (± 2 days) will be considered acceptable for each scheduled visit following the baseline visit.
During Visit 1 (Screening), informed consent will be obtained before any study procedures take place. After subject has been consented, medical history will then be documented, including the concomitant medications (if any). Physical examination and ECG will be carried out for all subjects. Subjects' vital signs will be recorded along with pulse pressure (PP).Their laboratory investigations like Hematology, Clinical chemistry and Urinalysis will be done. They shall undergo the screening procedure by inclusion and exclusion criteria. Subject's demography data will be collected. They will be given instructions for the next visit.
At Visit 2 (Day 1, Baseline visit), eligibility confirmation will be done, and each enrolled subject will be randomly assigned in double-blind fashion, in 1:1 ratio to the test product or the Placebo. Blinded investigational product will be dispensed to subjects who meet all the inclusion and none of the exclusion criteria. Subjects will be instructed to take two capsules of the either placebo or NMN once a day with ambient temperature water after breakfast. They shall be recording the dosing details in subject diaries. The first dose of Investigational Product will be taken by the subject at home. Subjects will be evaluated through SF-36 questionnaire for their health. They will be required to answer few questions pertaining to their health. (PI, CRC or site staff will fill SF-36 questionnaire in visit 2, 3 and 4 by asking the subject). All the baseline assessments for efficacy will be performed.
At visit 3 (Day 30) and visit 4 (Day 60), subjects will return to the clinic to review and collect subjects' diaries, safety data, and medication reconciliation. Efficacy and safety assessments will be done at both the visits.
Subjects will be asked to bring their subject diaries and used/unused Investigational Products every time they visit the site. Enough quantity of Investigational Product will be dispensed every visit. Subjects' vital signs will be recorded along with pulse pressure (PP) at all visits. Adverse event assessment and concomitant assessment will be done at each visit along with compliance with drug applications.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled
| Arm | Type | Receives |
|---|---|---|
| Investigational Product | Experimental | Other: NMNIngredient: NMN Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days |
| Placebo | Placebo comparator | Other: PlaceboIngredient: Starch powder Dosage form: Capsule, 150 mg/capsule Frequency: 2 capsules per day Duration: 60 days |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NMNInvestigational Product | Other | Investigational Product |
| PlaceboStarch Powder | Other | Placebo |
Primary outcome
Blood cellular NAD+ concentration in serum
Time frame: Day 2
Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study
Blood cellular NAD+ concentration in serum
Time frame: Day 30
Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study
Blood cellular NAD+ concentration in serum
Time frame: Day 60
Evaluation of Blood cellular NAD+ concentration in serum inter group comparison from baseline to the end of study
Blood cellular NADH concentration in serum
Time frame: Day 2
Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study
Blood cellular NADH concentration in serum
Time frame: Day 30
Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study
Blood cellular NADH concentration in serum
Time frame: Day 60
Evaluation of Blood cellular NADH concentration in serum inter group comparison from baseline to the end of study
Six minutes walking endurance test
Time frame: Day 2
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
Six minutes walking endurance test
Time frame: Day 30
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
Six minutes walking endurance test
Time frame: Day 60
Evaluation of Six minutes walking endurance test inter group comparison from baseline to the end of study
Systolic
Time frame: Day 2
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
Systolic
Time frame: Day 30
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
Systolic
Time frame: Day 60
Evaluation of Systolic blood pressure inter group comparison from baseline to the end of study
Diastolic blood pressure
Time frame: Day 2
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
Diastolic blood pressure
Time frame: Day 30
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
Diastolic blood pressure
Time frame: Day 60
Evaluation of diastolic blood pressure inter group comparison from baseline to the end of study
Pulse pressure
Time frame: Day 2
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
Pulse pressure
Time frame: Day 30
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
Pulse pressure
Time frame: Day 60
Evaluation of Pulse Pressure inter group comparison from baseline to the end of study
SF-36 questionnaire
Time frame: Day 2
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
SF-36 questionnaire
Time frame: Day 30
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
SF-36 questionnaire
Time frame: Day 60
Evaluation of SF-36 questionnaire inter group comparison from baseline to the end of study
18 secondary outcomes
Adverse events
Time frame: Day 2
Adverse events
Time frame: Day 30
Adverse events
Time frame: Day 60
Laboratory parameter (blood chemistry)
Time frame: Day 1
Laboratory parameter (blood chemistry)
Time frame: Day 30
Laboratory parameter (blood chemistry)
Time frame: Day 60
Laboratory parameter (lipid profile)
Time frame: Day 1
Laboratory parameter (lipid profile)
Time frame: Day 30
Laboratory parameter (lipid profile)
Time frame: Day 60
Laboratory parameter (LFT )
Time frame: Day 1
Laboratory parameter (LFT)
Time frame: Day 30
Laboratory parameter (LFT)
Time frame: Day 60
Laboratory parameter (RFT)
Time frame: Day 1
Laboratory parameter (RFT)
Time frame: Day 30
Laboratory parameter (RFT)
Time frame: Day 60
Drop out due to adverse events
Time frame: Day 2
Drop out due to adverse events
Time frame: Day 30
Drop out due to adverse events
Time frame: Day 60
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Derived from this study: PubMed 35821806Huang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ganesh Avhad principal investigator
Swasthiye Clinic and Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMN in people with Aging, run by EffePharm LTD at 2 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood cellular NAD+ concentration in serum (time frame: Day 2). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04228640, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2021.