Clinical trial NCT05483465: The Effect of NAD Supplementation on Brain Vascular Health in Aging
Official title: Effects of NAD Restoration on Neurovascular Coupling in Community Dwelling Older Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Aging
Keywords: NAD
NR
nicotinamide riboside
neurovascular coupling
endothelial function
cognitive function
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: Oklahoma Medical Research Foundation
name: Elysium Health
First posted: 2022-08-02
Enrollment: 214
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blinded, placebo-controlled, parallel study design
Primary purpose: OTHER

Brief 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.

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).

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS)
timeFrame: 8 weeks
measure: Change in neurovascular coupling using transcranial Doppler
timeFrame: 8 weeks
measure: Change in neurovascular coupling using the dynamic retinal vessel analysis
timeFrame: 8 weeks
measure: Change in neuronal activity
timeFrame: 8 weeks
Secondary outcomes:
measure: Change in microvascular endothelial function
timeFrame: 8 weeks
measure: Change in macrovascular endothelial function
timeFrame: 8 weeks
measure: Change in deep tissue oxygen saturation
timeFrame: 8 weeks
measure: Change in arterial stiffness
timeFrame: 8 weeks
measure: Change in ECG
timeFrame: 8 weeks
measure: Change in Glycocalyx - perfused boundary region
timeFrame: 8 weeks
measure: Change in capillary density
timeFrame: 8 weeks
measure: Change in red blood cell velocity
timeFrame: 8 weeks
measure: Change in Attention
timeFrame: 8 weeks
measure: Change in Episodic Memory
timeFrame: 8 weeks
measure: Change in Working Memory
timeFrame: 8 weeks
measure: Change in Language
timeFrame: 8 weeks
measure: Change in Executive Function
timeFrame: 8 weeks
measure: Change in Processing Speed
timeFrame: 8 weeks
measure: Blood collection
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: Andriy Yabluchanskiy, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: