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The Effect of NAD Supplementation on Brain Vascular Health in Aging

Plain-language guide to NCT05483465: phase 4 randomized trial of NAD+, 214 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT05483465
Phase
phase 4
Status
recruiting participants
Start
2023-05-03
Completion (planned or actual)
2027-06
Participants
214 (estimated)
Design
randomized, triple-blind, other
Conditions studied
Aging
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

This registered phase 4 trial tested NAD+.

Daily consumption of one of the forms of Vitamin B3, the Nicotinamide Riboside (NR), energizes the body and combats cellular aging.

It had two arms (groups): NR (experimental) and Control (placebo comparator).

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

The registry classes the interventions as drug.

Who Took Part

214 planned participants were the target.

It was open to people of any sex aged from 60 years up to 85 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could 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.

The full record lists 5 inclusion and 8 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and triple-blind.

Random assignment meant chance, not the researchers, decided who got NAD+ and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Neither the participants nor the staff measuring them knew who was on NAD+, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2023-05-03 with completion listed for 2027-06.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Change in neurovascular coupling using functional near infrared spectroscopy (fNIRS) (time frame: 8 weeks). Change in neurovascular coupling using transcranial Doppler (time frame: 8 weeks). Change in neurovascular coupling using the dynamic retinal vessel analysis (time frame: 8 weeks).

It also tracked 15 secondary outcomes, for example Change in microvascular endothelial function, Change in macrovascular endothelial function, Change in deep tissue oxygen saturation, Change in arterial stiffness, Change in ECG and Change in Glycocalyx - perfused boundary region.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of NAD+ in 214 people.

It is still recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the NAD+ compound page, all human trials.

Our Notes on the Compound

NAD+: The coenzyme that accepts electrons at complex I.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.