Healthy AgingNCT06889740
Evaluate the Safety, Tolerability, and Efficacy of UthPeak NMNH (Reduced β-Nicotinamide Mononucleotide Calcium Salt) in Healthy Adult Participants
A study testing NMNH-Ca in people with Healthy Aging, run by EffePharm LTD at 2 sites in India.
Trial summary
This randomized, double-blind, placebo-controlled trial evaluated the effects of 90-day NMNH-Ca supplementation on blood NAD⁺ levels, blood phenotypic age, physical function, BMI, and health-related quality of life in healthy adults, together with its safety and tolerability. Read more about this study
- Who is it for?
- Ages 40 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- NMNH-Ca
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesIndia
- Study dates
- 8 Jul 2024to 25 Jan 2025
- 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
- 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.
Who cannot join
- 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.
Show all 18Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
India2 sites
Medstar Speciality Hospital
Bengaluru, Karnataka, 560092
Vinayaka Mission's Medical College and Hospital
Kāraikāl, Puducherry, 609609
About this study
Official title: A Prospective, Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of UthPeak NMNH (Reduced β-Nicotinamide Mononucleotide Calcium Salt) in Healthy Adult Participants
This randomized, double-blind, placebo-controlled trial evaluated the effects of 90-day NMNH-Ca supplementation on blood NAD⁺ levels, blood phenotypic age, physical function, BMI, and health-related quality of life in healthy adults, together with its safety and tolerability.
Read the detailed description
A total of 80 healthy adult participants were considered for enrollment 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-Ca 125 mg group, NMNH-Ca 250 mg group, or NMNH-Ca 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 parameters were also evaluated during Day 45 and day 90 . Participants were formally enrolled in the study after reconfirmation of eligibility.
Blood samples were also collected at multiple time points (0h, 0.5h, 1h, 2h, 4h, 6h, 12h, and 24h) after the first dose of supplementation to assess NAD+ levels, which were conducted exclusively for the second set of 10 participants in each group who provided informed consent.
Throughout the study, physical examinations, vital signs, concomitant medications, and adverse events were recorded.
- Conditions
- Healthy Aging
- Being tested
- NMNH-Ca, Placebo
- Keywords
- UthPeak, NMNH, Reduced NMN, Reduced β-nicotinamide mononucleotide calcium salt
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NMNH-CaOther
Reduced Nicotinamide Mononucleotide Calcium salt
PlaceboOther
Starch powder
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Placebo comparator | Ingredient: Starch Dosage form: Capsule, 125mg/capsule Frequency: 2 capsules per day Duration: 90 days Receives: Other: Placebo |
| Group 2 | Experimental | Ingredient: NMNH-Ca Dosage form: Capsule, 62.5 mg/capsule Frequency: 2 capsules per day Duration: 90 days Receives: Other: NMNH-Ca |
| Group 3 | Experimental | Ingredient: NMNH-Ca Dosage form: Capsule, 125 mg/capsule Frequency: 2 capsules per day Duration: 90 days Receives: Other: NMNH-Ca |
| Group 4 | Experimental | Ingredient: NMNH-Ca Dosage form: Capsule, 250 mg/capsule Frequency: 2 capsules per day Duration: 90 days Receives: Other: NMNH-Ca |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess NAD+ Values in blood
To assess NAD+ Values in blood
Measured: day 0, day 45, day 90
Assessment of Biological Age
Assessment of Biological Age by an online biological age calculator
Measured: day 0, day 45, day 90
Physical Performance walking test
Physical Performance is assessed by endurance test measured on six minutes
Measured: day 0, day 45, day 90
Change in BMI
BMI
Measured: day 0, day 45, day 90
Quality (QoL) Questionnaire
The 36-Item Short Form Health Survey (SF-36) was used to assess Health-Related Quality of Life. It measures eight scales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores range from 0 to 100, with higher scores indicating a more favorable health state.
Measured: day 0, day 45, day 90
Secondary outcomes (2)
Safety will be assessed based on number of adverse events
Safety will be assessed based on number of adverse events
Measured: day 0, day 45, day 90
Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events
Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events
Measured: day 0, day 45, day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start8 Jul 2024
- Primary completion8 Dec 2024
- Study completion25 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Healthy 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- EffePharm LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jiayan Li, Study director, EffePharm LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889740
- Sponsor's protocol ID
- Study No. EP_RNM_001_24
- Status last verified
- Jul 2025
- First submitted
- 17 Mar 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zapata-Perez R, Tammaro A, Schomakers BV, Scantlebery AML, Denis S, Elfrink HL, Giroud-Gerbetant J, Canto C, Lopez-Leonardo C, McIntyre RL, van Weeghel M, Sanchez-Ferrer A, Houtkooper RH. Reduced nicotinamide mononucleotide is a new and potent NAD+ precursor in mammalian cells and mice. FASEB J. 2021 Apr;35(4):e21456. doi: 10.1096/fj.202001826R.
PubMed 33724555Smolin AG. Ab Initio Studies of NMNH(2-) Conformers in Water-Methanol Solutions: Comparative Analysis of the Biexponential Fluorescence Signals for NMNH(2-) and NADH. J Phys Chem B. 2022 Dec 29;126(51):10870-10881. doi: 10.1021/acs.jpcb.2c08220. Epub 2022 Dec 16.
PubMed 36524597
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study to Evaluate the Safety, Tolerability, and Exploratory Efficacy of UthPeak NMNH (Reduced β-Nicotinamide Mononucleotide Calcium Salt) in Healthy Adult Participants
- ClinicalTrials.gov ID
- NCT06889740
- Acronym / sponsor ID
- Study No. EP_RNM_001_24
- Conditions
- Healthy Aging
- Keywords
- UthPeak, NMNH, Reduced NMN, Reduced β-nicotinamide mononucleotide calcium salt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- EffePharm LTDIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 8 Dec 2024 (actual)
- Study completion
- 25 Jan 2025 (actual)
- First posted
- 21 Mar 2025 (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 randomized, double-blind, placebo-controlled trial evaluated the effects of 90-day NMNH-Ca supplementation on blood NAD⁺ levels, blood phenotypic age, physical function, BMI, and health-related quality of life in healthy adults, together with its safety and tolerability.
Detailed description
A total of 80 healthy adult participants were considered for enrollment 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-Ca 125 mg group, NMNH-Ca 250 mg group, or NMNH-Ca 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 parameters were also evaluated during Day 45 and day 90 . Participants were formally enrolled in the study after reconfirmation of eligibility.
Blood samples were also collected at multiple time points (0h, 0.5h, 1h, 2h, 4h, 6h, 12h, and 24h) after the first dose of supplementation to assess NAD+ levels, which were conducted exclusively for the second set of 10 participants in each group who provided informed consent.
Throughout the study, physical examinations, vital signs, concomitant medications, and adverse events were recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
- Model description
- Multi-center, Double-blind, Placebo-controlled, Randomized, Multiple-arm, Parallel Study
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Placebo comparator | Other: PlaceboIngredient: Starch Dosage form: Capsule, 125mg/capsule Frequency: 2 capsules per day Duration: 90 days |
| Group 2 | Experimental | Other: NMNH-CaIngredient: NMNH-Ca Dosage form: Capsule, 62.5 mg/capsule Frequency: 2 capsules per day Duration: 90 days |
| Group 3 | Experimental | Other: NMNH-CaIngredient: NMNH-Ca Dosage form: Capsule, 125 mg/capsule Frequency: 2 capsules per day Duration: 90 days |
| Group 4 | Experimental | Other: NMNH-CaIngredient: NMNH-Ca Dosage form: Capsule, 250 mg/capsule Frequency: 2 capsules per day Duration: 90 days |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
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 |
|---|---|---|
| NMNH-CaReduced Nicotinamide Mononucleotide Calcium salt | Other | Group 2, Group 3, Group 4 |
| PlaceboStarch powder | Other | Group 1 |
Primary outcome
To assess NAD+ Values in blood
Time frame: day 0, day 45, day 90
To assess NAD+ Values in blood
Assessment of Biological Age
Time frame: day 0, day 45, day 90
Assessment of Biological Age by an online biological age calculator
Physical Performance walking test
Time frame: day 0, day 45, day 90
Physical Performance is assessed by endurance test measured on six minutes
Change in BMI
Time frame: day 0, day 45, day 90
BMI
Quality (QoL) Questionnaire
Time frame: day 0, day 45, day 90
The 36-Item Short Form Health Survey (SF-36) was used to assess Health-Related Quality of Life. It measures eight scales: physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health perceptions. Scores range from 0 to 100, with higher scores indicating a more favorable health state.
2 secondary outcomes
Safety will be assessed based on number of adverse events
Time frame: day 0, day 45, day 90
Tolerability will be assessed based on number of subjects drop out due to treatment related adverse events
Time frame: day 0, day 45, day 90
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 27 Oct 2026.
- Results publication: PubMed 33724555Zapata-Perez R, Tammaro A, Schomakers BV, Scantlebery AML, Denis S, Elfrink HL, Giroud-Gerbetant J, Canto C, Lopez-Leonardo C, McIntyre RL, van Weeghel M, Sanchez-Ferrer A, Houtkooper RH. Reduced nicotinamide mononucleotide is a new and potent NAD+ precursor in mammalian cells and mice. FASEB J. 2021 Apr;35(4):e21456. doi: 10.1096/fj.202001826R.
- Results publication: PubMed 36524597Smolin AG. Ab Initio Studies of NMNH(2-) Conformers in Water-Methanol Solutions: Comparative Analysis of the Biexponential Fluorescence Signals for NMNH(2-) and NADH. J Phys Chem B. 2022 Dec 29;126(51):10870-10881. doi: 10.1021/acs.jpcb.2c08220. Epub 2022 Dec 16.
- 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.
Jiayan Li study director
EffePharm LTD
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NMNH-Ca in people with Healthy 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 7 inclusion and 18 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 27 Oct 2026. 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?
To assess NAD+ Values in blood (time frame: day 0, day 45, day 90). The study lists 5 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 NCT06889740, which also lists 2 linked publications.
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 27 Oct 2026.