NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals
- Conditions
- Sleep
- Registration Number
- NCT06971224
- Lead Sponsor
- Haukeland University Hospital
- Brief Summary
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.
- Detailed Description
Nicotinamide adenine dinucleotide (NAD+) is important for regulating cellular energy metabolism, mitochondrial function, and circadian rhythms, which are key processes involved in the sleep-wake cycle and sleep regulation. Nicotinamide riboside (NR) supplementation has been shown to elevate NAD+ levels in humans. Higher NAD+ levels may support better sleep by restoration of mitochondrial efficiency and reducing oxidative stress.
As people age, there is evidence of a decline in NAD+ levels, which may lead to mitochondrial dysfunction, oxidative stress, and disruptions in circadian rhythms. These changes can negatively affect sleep architecture and reduce sleep quality. Impaired NAD+ metabolism has been linked to problems with the molecular clock, which regulates circadian timing through effects on sirtuin activity and clock genes such as BMAL1. NAD+ also supports brain metabolism by maintaining mitochondrial function, promoting neuroprotection, regulating redox balance, and reducing neuroinflammation. By restoring NAD+ levels, NR supplementation may help improve mitochondrial efficiency, decrease oxidative damage, and enhance sleep-related cellular maintenance. NR may also support synchronization of circadian rhythms, further promoting healthy sleep. Its effects also include modulating neuroinflammatory pathways and strengthening cellular resilience against oxidative stress, both of which are essential for maintaining cognitive functions and neural plasticity during sleep.
The NADream study will test whether NR supplementation can improve both objective and subjective measures of sleep in healthy adults. Sleep will be assessed using polysomnography (PSG), the gold standard for objective sleep measurement, along with actigraphy, Somnofy sleep monitoring, and the Pittsburgh Sleep Quality Index (PSQI). This study will be a randomized, placebo-controlled, double-blind, parallel-group design. Participants will be randomly assigned to receive ether NR or a placebo for 8 weeks. The findings from this study will help determine whether NR supplementation could be a viable therapeutic option to explore further in this area.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 16
- 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.
- Self-reported normal sleep patterns, assessed by Pittsburgh sleep quality index (PSQI; cutoff ≤ 5).
- No current use of sleep medications or supplements.
- Able to wear polysomnographic equipment and actigraphy during nighttime.
- 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).
- Travelled >1 time zone and night work <1 month before study, or during the study.
- Extreme chronotype according to the Composite Morningness Questionnaire (evening type; <22 and morning type >44).
- Pregnancy.
- Breastfeeding.
- Supplements resulting in > 20 mg daily of nicotinamide riboside, nicotinamide mononucleotide (NMN), niacin (vitamin B3, nicotinic acid amide or other vitamin B3 analogues) less than 3 months prior to randomization.
- Participation in other clinical trials last 3 months.
- Deemed ineligible by lead principal investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The primary objective is to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG). From enrollment to the end of treatment at 8 weeks. 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 Outcome Measures
Name Time Method The secondary endpoints are to evaluate the effect of NAD supplementation on objective sleep parameters via polysomnography (PSG). From enrollment to the end of treatment at 8 weeks. Slow wave energy (SWE) during sleep. Accumulated SWA as a putative homeostatic marker of sleep drive.
EEG power From enrollment to the end of treatment at 8 weeks. EEG power for each sleep stage in 1 Hz bins from 1 to 20 Hz.
Arousals during sleep. From enrollment to the end of treatment at 8 weeks. Arousals during sleep (abrupt cortical awakenings lasting \>3 seconds).
Sleep efficiency (SE). From enrollment to the end of treatment at 8 weeks. Sleep efficiency (SE) (time asleep/TIBx100)
Theta activity. From enrollment to the end of treatment at 8 weeks. Theta activity (5 - 8 Hz) during REM sleep, as a marker of REM sleep quality.
Time in bed (TIB). From enrollment to the end of treatment at 8 weeks. Time in bed (TIB, in minutes). Total time the person is laying down in bed.
Sleep onset latency (SOL). From enrollment to the end of treatment at 8 weeks. Sleep onset latency (SOL, in minutes). Length of time from full wakefulness to sleep.
Total sleep time (TST). From enrollment to the end of treatment at 8 weeks. Total sleep time (TST, in minutes). Total time the person sleeps.
Sleep architecture. From enrollment to the end of treatment at 8 weeks. Sleep architecture: time spent in non-rapid eye movement (NREM) stages and REM sleep, particularly the more restorative and deep sleep (stage N3/slow wave sleep) will be examined.
Wake after sleep onset (WASO). From enrollment to the end of treatment at 8 weeks. Wake after sleep onset (WASO, in minutes). Periods of wakefulness after defined sleep onset.
Trial Locations
- Locations (1)
Haukeland University Hospital
🇳🇴Bergen, Norway