AgingPhase 4NCT05483465
The Effect of NAD Supplementation on Brain Vascular Health in Aging
A Phase 4 study testing Nicotinamide riboside in people with Aging, run by University of Oklahoma at 1 site in United States.
Trial summary
Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging. This study is designed to test whether NR can also improve brain health and memory. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Nicotinamide riboside
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 214 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2023to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥60 and ≤85 years of age
- Adequate hearing and visual acuity to participate in the examinations
- Ability to read and write in English
- Competence to provide informed consent.
- Mini-Mental State Exam score ≥24
Who cannot join
- Vision or hearing impairment that would impair the ability to complete study assessments
- Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
- Cerebrovascular accident other than TIA within 60 days prior to Visit 0
- Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
- Abnormal kidney function (creatinine >2mg/dL or EGFR <30mL/min) by most recent labs within 6 months prior to Visit 0
- Elevated liver enzymes (AST and/or ALT above x2 upper limit of normal) by most recent labs within 6 months prior to Visit 0
- Treatment with other NAD enhancers (Nicotinamide riboside or nicotinamide mononucleotide) within 4 weeks prior to randomization.
- Any other medical condition which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73117
Andriy Yabluchanskiy, MD, PhD, 405-271-8130, andriy-yabluchanskiy@ouhsc.edu
Peter Mukli, MD, PhD, 405-271-8000 ext. 47097, peter-mukli@ouhsc.edu
About this study
Official title: Effects of NAD Restoration on Neurovascular Coupling in Community Dwelling Older Adults
Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging. This study is designed to test whether NR can also improve brain health and memory.
Read the detailed description
This study is designed to test the hypothesis that restoration of Nicotinamide Adenine Dinucleotide (NAD) levels with Nicotinamide Riboside (NR) in older adults will improve neurovascular coupling (NVC) responses and micro- and macrovascular endothelial function. This hypothesis will be tested by assessing the effects of treatment with oral NR (1g/day per os for 8 weeks) or placebo (8 weeks) in community dwelling older adults (60-85 years of age).
- Conditions
- Aging
- Being tested
- Nicotinamide riboside, Placebo
- Keywords
- NAD, NR, nicotinamide riboside, neurovascular coupling, endothelial function, cognitive function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nicotinamide ribosideDrug
Also called NR
Oral NR, 1g/day per os for 8 weeks
PlaceboDrug
Also called Sugar pill
Visually identical pill to NR, daily per os for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| NR | Experimental | Treatment with oral NR (1g/day per os for 8 weeks) Receives: Drug: Nicotinamide riboside |
| Control | Placebo comparator | Visually identical placebo (daily, per os, for 8 weeks) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after treatment. Units of measure - beta. Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in neurovascular coupling using transcranial Doppler
Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment. Units of measure - % change between the n-back tasks. Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in neurovascular coupling using the dynamic retinal vessel analysis
Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). Units of measure mm, reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in neuronal activity
EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Secondary outcomes (15)
Change in microvascular endothelial function
Changes in microvascular endothelial function will be assessed using laser speckle contrast imaging (LSCI) in the hand using the flow mediated dilation approach. The change in skin perfusion is calculated and reported as a %change from baseline, between before and after treatment. Units of measure - perfusion index (arbitrary units). Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in macrovascular endothelial function
Changes in macrovascular endothelial function will be assessed using sonography during flow mediated dilation approach. The change in brachial artery diameter (mm) is calculated and reported as a %change from baseline, between before and after treatment.
Measured: 8 weeks
Change in deep tissue oxygen saturation
Transcutaneous deep tissue oxygen saturation will be measured using the inSpectra near infrared device. The data are calculated and reported as a %change from baseline, between before and after treatment.
Measured: 8 weeks
Change in arterial stiffness
The arterial stiffness will be measured using the pulse wave analysis approach (SphygmoCor, Atcor medical, Itasca IL, or similar). Analysis generates the augmentation index which will be used for comparison before and after treatment.
Measured: 8 weeks
Change in ECG
ECG will be recorded for heart rate variability analysis. The values of high frequency domain, low frequency domain, their ratio, as well as total power will be calculated and used for comparison before and after treatment.
Measured: 8 weeks
Change in Glycocalyx - perfused boundary region
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include perfused boundary region (um), and will be used for comparison before and after treatment.
Measured: 8 weeks
Change in capillary density
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include capillary density (mm/mm^2), and will be used for comparison before and after treatment.
Measured: 8 weeks
Change in red blood cell velocity
Video recordings of the sublingual vasculature will be performed using the high definition video camera GlycoCheck (Microvascular health solutions). Data collected will include red blood cell velocity (um/sec), and will be used for comparison before and after treatment.
Measured: 8 weeks
Change in Attention
The allocation of one's limited capacities to deal with an abundance of environmental stimulation will be measured in a combined "Flanker Inhibitory Control and Attention Test".Units of measure - score (from 0 to 10, bigger number is better). Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in Episodic Memory
Cognitive processes involved in the acquisition, storage and retrieval of new information, will be measured using the "Picture Sequence Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in Working Memory
The ability to store information until the amount of information to be stored exceeds one's capacity to hold that information will be measured using the "List Sorting Working Memory Test". Unit of measure - overall score (bigger number is better). Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in Language
Picture Vocabulary Test measures receptive vocabulary administered in a computer-adaptive test (CAT) format. Respondents select the picture that most closely matches the meaning of the word, before and after treatment. Unit of measure - overall score (bigger number is better). Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in Executive Function
The capacity to plan, organize and monitor the executive of behaviors that are strategically directed in a goal-oriented manner will be measured using the "Dimensional Change Card Sort Test". Units of measure - score (from 0 to 10, bigger number is better). Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Change in Processing Speed
Pattern Comparison Processing Speed Test assesses the amount of information that can be processed within a certain unit of time. Items are simple so as to purely measure processing speed. Units of measure - score (from 0 to 130, bigger number is better). Reported as a %change from baseline, before and after treatment.
Measured: 8 weeks
Blood collection
Blood samples will be collected to measure concentration of NAD metabolites for comparison before and after treatment. Blood samples will also be used in in vitro assays to measure the effect of treatment on endothelial function.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start3 May 2023
- Primary completionJun 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blinded, placebo-controlled, parallel study design
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 214 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Collaborators
- University of Pennsylvania, Oklahoma Medical Research Foundation, Elysium Health
- Responsible party
- Sponsor
- Investigators
- Andriy Yabluchanskiy, MD, PhD, Principal investigator, University of Oklahoma
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483465
- Sponsor's protocol ID
- 14782
- Status last verified
- Mar 2026
- First submitted
- 29 Jul 2022
- Last updated
- 1 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The results may be uploaded to scientific online repositories such as PhysioNet (or other) as requested by the journal when data is submitted for publication. In that case, all data will be de-identified and labeled by group+number (for example Placebo1, Placebo2, NR1, NR2, these IDs will be different from study IDs stored on the servers at the OUHSC) and supported by subjects' age, sex, comorbidities and treatments data.
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of NAD Restoration on Neurovascular Coupling in Community Dwelling Older Adults
- ClinicalTrials.gov ID
- NCT05483465
- Acronym / sponsor ID
- 14782
- Conditions
- Aging
- Keywords
- NAD, NR, nicotinamide riboside, neurovascular coupling, endothelial function, cognitive function
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 214 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Collaborators
- University of Pennsylvania, Oklahoma Medical Research Foundation, Elysium Health
- Study start
- 3 May 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 2 Aug 2022 (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.
Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging. This study is designed to test whether NR can also improve brain health and memory.
Detailed description
This study is designed to test the hypothesis that restoration of Nicotinamide Adenine Dinucleotide (NAD) levels with Nicotinamide Riboside (NR) in older adults will improve neurovascular coupling (NVC) responses and micro- and macrovascular endothelial function. This hypothesis will be tested by assessing the effects of treatment with oral NR (1g/day per os for 8 weeks) or placebo (8 weeks) in community dwelling older adults (60-85 years of age).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blinded, placebo-controlled, parallel study design
| Arm | Type | Receives |
|---|---|---|
| NR | Experimental | Drug: Nicotinamide ribosideTreatment with oral NR (1g/day per os for 8 weeks) |
| Control | Placebo comparator | Drug: PlaceboVisually identical placebo (daily, per os, for 8 weeks) |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥60 and ≤85 years of age
- Adequate hearing and visual acuity to participate in the examinations
- Ability to read and write in English
- Competence to provide informed consent.
- Mini-Mental State Exam score ≥24
Key exclusion criteria (8 listed)
- Vision or hearing impairment that would impair the ability to complete study assessments
- Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
- Cerebrovascular accident other than TIA within 60 days prior to Visit 0
- Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
- Abnormal kidney function (creatinine >2mg/dL or EGFR <30mL/min) by most recent labs within 6 months prior to Visit 0
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 |
|---|---|---|
| Nicotinamide ribosideAlso: NROral NR, 1g/day per os for 8 weeks | Drug | NR |
| PlaceboAlso: Sugar pillVisually identical pill to NR, daily per os for 8 weeks | Drug | Control |
Primary outcome
Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
Time frame: 8 weeks
Functional near infrared spectroscopy (fNIRS) will be performed during the cognitive n-back task. fNIRS approach generates data that represent a relative change in oxygenated and deoxygenated hemoglobin measured over the cortical brain tissues. Neurovascular coupling will be evaluated as a change in oxy- and deoxy-hemoglobin between before and after treatment. Units of measure - beta. Reported as a %change from baseline, before and after treatment.
Change in neurovascular coupling using transcranial Doppler
Time frame: 8 weeks
Transcranial Doppler sonography will be used to measure the change in the blood flow velocities during the cognitive n-back task between before and after treatment. Units of measure - % change between the n-back tasks. Reported as a %change from baseline, before and after treatment.
Change in neurovascular coupling using the dynamic retinal vessel analysis
Time frame: 8 weeks
Flicker light-induced dilation of the retinal vessels (percentage increase over baseline diameter) will be measured in the right or left eye of each study participant using the Dynamic Vessel Analyzer (DVA, IMEDOS Systems, Jena, Germany). Units of measure mm, reported as a %change from baseline, before and after treatment.
Change in neuronal activity
Time frame: 8 weeks
EEG signal will be collected to generate spectral data. These data will be used for comparison of EEG activity between before and after treatment. Units of measure - power spectral density. Reported as a %change from baseline, before and after treatment.
15 secondary outcomes
Change in microvascular endothelial function
Time frame: 8 weeks
Change in macrovascular endothelial function
Time frame: 8 weeks
Change in deep tissue oxygen saturation
Time frame: 8 weeks
Change in arterial stiffness
Time frame: 8 weeks
Change in ECG
Time frame: 8 weeks
Change in Glycocalyx - perfused boundary region
Time frame: 8 weeks
Change in capillary density
Time frame: 8 weeks
Change in red blood cell velocity
Time frame: 8 weeks
Change in Attention
Time frame: 8 weeks
Change in Episodic Memory
Time frame: 8 weeks
Change in Working Memory
Time frame: 8 weeks
Change in Language
Time frame: 8 weeks
Change in Executive Function
Time frame: 8 weeks
Change in Processing Speed
Time frame: 8 weeks
Blood collection
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2026.
- Individual participant dataSharing planned: No. The results may be uploaded to scientific online repositories such as PhysioNet (or other) as requested by the journal when data is submitted for publication. In that case, all data will be de-identified and labeled by group+number (for example Placebo1, Placebo2, NR1, NR2, these IDs will be different from study IDs stored on the servers at the OUHSC) and supported by subjects' age, sex, comorbidities and treatments data.
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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.
Andriy Yabluchanskiy, MD, PhD principal investigator
University of Oklahoma
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Nicotinamide riboside in people with Aging, run by University of Oklahoma at 1 site in United States.
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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Andriy Yabluchanskiy, MD, PhD (405-271-7622, andriy-yabluchanskiy@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS) (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2026.