The Effect of NAD Supplementation on Brain Vascular Health in Aging

NCT ID: NCT05483465

Last Updated: 2024-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

214 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-03

Study Completion Date

2027-12-31

Brief Summary

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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

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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

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Aging

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized, double-blinded, placebo-controlled, parallel study design
Primary Study Purpose

OTHER

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
All data will be unmasked upon completion of the trial, or during performance of data review if requested by the data safety and monitoring board.

Study Groups

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NR

Treatment with oral NR (1g/day per os for 8 weeks)

Group Type EXPERIMENTAL

Nicotinamide riboside

Intervention Type DRUG

Oral NR, 1g/day per os for 8 weeks

Control

Visually identical placebo (daily, per os, for 8 weeks)

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Visually identical pill to NR, daily per os for 8 weeks

Interventions

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Nicotinamide riboside

Oral NR, 1g/day per os for 8 weeks

Intervention Type DRUG

Placebo

Visually identical pill to NR, daily per os for 8 weeks

Intervention Type DRUG

Other Intervention Names

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NR Sugar pill

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Pennsylvania

OTHER

Sponsor Role collaborator

Oklahoma Medical Research Foundation

OTHER

Sponsor Role collaborator

Elysium Health

INDUSTRY

Sponsor Role collaborator

University of Oklahoma

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andriy Yabluchanskiy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

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University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Andriy Yabluchanskiy, MD, PhD

Role: CONTACT

405-271-7622

Facility Contacts

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Andriy Yabluchanskiy, MD, PhD

Role: primary

405-271-8130

Peter Mukli, MD, PhD

Role: backup

405-271-8000 ext. 47097

Other Identifiers

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14782

Identifier Type: -

Identifier Source: org_study_id

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