About this trial
The purpose of this study is to evalue the effects of nicotinamide adenine dinucleotide (NAD) supplementation (nicotinamide riboside (NR) form) on sleep in healthy adults compared to a placebo. NAD is important for brain health and energy balance and a proposed explanation for its effect on sleep is that NAD supplementation restores the neurophysiological capacity of the brain to 'rest' during sleep. If this is the case, we expect the administration to result in improvements in sleep quality (and most likely sleep quantity) compared to placebo. Participants will receive either NAD supplementation or a placebo and their sleep will be measured to detect any differences between the two groups.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Participant must be 40 to 60 years of age inclusive, at the time of signing the informed consent.
Male or female.
Participants who are healthy as determined by medical evaluation including medical history and physical examination.
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the study protocol.
Disqualifiers
History of sleep disorders (e.g. insomnia, sleep apnea).
Abnormal findings on PSG, such as sleep related breathing disorders (apnea-hypopnea index (AHI) ≥ 5), sleep related movement disorders (periodic limb movement index (PLMI) ≥ 15, and parasomnias (like REM sleep behavior disorder (RBD)).
Chronic use of alcohol, tobacco, or medications affecting sleep.
Significant psychiatric or medical conditions (including neurological, heart, lung, or sleep disorders/diseases).
Trial design
Parallel
Treatments tested in this trial
Nicotinamide Riboside (NR)
Dietary supplement2000 mg NR daily.
Placebo
Other interventionPlacebo tablet identical in taste, shape and appearance to NR tablets.
Treatment groups
Trial outcomes
Primary outcomes
The primary objective is to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG).
The primary endpoint is the change in electrophysiological slow-wave activity (SWA; 0.5 - 4.0 Hz) per 60 minutes, measured by EEG, from baseline to week 8 between the 2000 mg NR and placebo groups.
Secondary outcomes
The secondary endpoints are to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG).
Slow wave energy (SWE) during sleep. Accumulated SWA as a putative homeostatic marker of sleep drive.
EEG power
EEG power for each sleep stage in 1 Hz bins from 1 to 20 Hz.
Arousals during sleep.
Arousals during sleep (abrupt cortical awakenings lasting \>3 seconds).
Theta activity.
Theta activity (5 - 8 Hz) during REM sleep, as a marker of REM sleep quality.
Other outcomes
Cognitive function.
Specific subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB).
Blood biomarkers.
Blood samples for oxidative stress biomarkers, including inflammatory profiles (CRP, IL-6, TNF-alpha).
NAD metabolome.
NAD metabolome in blood, measured by LC-MS metabolomics and/or NADMED assay.
Blood samples.
Blood samples for biobank.
Sponsors and contacts
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Haukeland University Hospital
Lead sponsor
University of Bergen
Collaborator