NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals

ConditionSleep
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40-60
SponsorHaukeland University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Nicotinamide Riboside (NR)

    Dietary supplement

    2000 mg NR daily.

  • Placebo

    Other intervention

    Placebo tablet identical in taste, shape and appearance to NR tablets.

Treatment groups

16 Participants
are divided into 2 treatment groups
Group A: Nicotinamide Riboside (NR)Experimental treatment 1 intervention
Group B: PlaceboOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 8 weeks.

Secondary outcomes

1

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.

Time frame
From enrollment to the end of treatment at 8 weeks.
2

EEG power

EEG power for each sleep stage in 1 Hz bins from 1 to 20 Hz.

Time frame
From enrollment to the end of treatment at 8 weeks.
3

Arousals during sleep.

Arousals during sleep (abrupt cortical awakenings lasting \>3 seconds).

Time frame
From enrollment to the end of treatment at 8 weeks.
4

Theta activity.

Theta activity (5 - 8 Hz) during REM sleep, as a marker of REM sleep quality.

Time frame
From enrollment to the end of treatment at 8 weeks.

Other outcomes

1

Cognitive function.

Specific subtests of the Cambridge Neuropsychological Test Automated Battery (CANTAB).

Time frame
From enrollment to the end of treatment at 8 weeks.
2

Blood biomarkers.

Blood samples for oxidative stress biomarkers, including inflammatory profiles (CRP, IL-6, TNF-alpha).

Time frame
From enrollment to the end of treatment at 8 weeks.
3

NAD metabolome.

NAD metabolome in blood, measured by LC-MS metabolomics and/or NADMED assay.

Time frame
From enrollment to the end of treatment at 8 weeks.
4

Blood samples.

Blood samples for biobank.

Time frame
From enrollment to the end of treatment at 8 weeks.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Haukeland University Hospital

Lead sponsor

University of Bergen

Collaborator