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

NCT ID: NCT06971224

Last Updated: 2025-09-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-13
• Study Completion Date: 2026-06-01

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.

Conditions

Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Nicotinamide Riboside (NR)

Nicotinamide Riboside (NR) administered in doses of 1000 mg twice daily for the duration of the trial (8 weeks).

Group Type: EXPERIMENTAL

Nicotinamide Riboside (NR)

Intervention Type: DIETARY_SUPPLEMENT

2000 mg NR daily.

Placebo

Placebo, no active ingredients. Administered in tablet form twice daily for the duration of the trial (8 weeks).

Group Type: OTHER

Placebo

Intervention Type: OTHER

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

Interventions

Nicotinamide Riboside (NR)

2000 mg NR daily.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: OTHER

Other Intervention Names

Nicotinamide adenine dinucleotide (NAD)

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bergen

OTHER

Sponsor Role: collaborator

Haukeland University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Charalampos Tzoulis, PhD

Role: STUDY_DIRECTOR

Haukeland University Hospital

Katarina Lundervold, MD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Janne Grønli, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Bergen

Locations

Haukeland University Hospital

Bergen, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Charalampos Tzoulis, PhD

Role: CONTACT

charalampos.tzoulis@helse-bergen.no

55975061 ext. 47

Katarina Lundervold, MD

Role: CONTACT

neurosysmedstudier@helse-bergen.no

55975045 ext. 47

Facility Contacts

Katarina Lundervold, MD

Role: primary

neurosysmedstudier@helse-bergen.no

55975045 ext. +47

Other Identifiers

2025/849242

Identifier Type: -

Identifier Source: org_study_id