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

NCT06971224 | Recruiting Phase 2 DMC

• 1 other identifier: 2025/849242
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep

Keywords

Sleep; Nicotinamide Riboside; NR; Nicotinamide adenine dinucleotide; NAD; Polysomonography; PSG

Outcome Measures

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.

  From enrollment to the end of treatment at 8 weeks.

Secondary Outcomes (10)

• 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.

• EEG power

  From enrollment to the end of treatment at 8 weeks.

• Arousals during sleep.

  From enrollment to the end of treatment at 8 weeks.

• Theta activity.

  From enrollment to the end of treatment at 8 weeks.

• Time in bed (TIB).

  From enrollment to the end of treatment at 8 weeks.

Other Outcomes (7)

• Cognitive function.

  From enrollment to the end of treatment at 8 weeks.

• Blood biomarkers.

  From enrollment to the end of treatment at 8 weeks.

• NAD metabolome.

  From enrollment to the end of treatment at 8 weeks.

Study Arms (2)

Nicotinamide Riboside (NR)

EXPERIMENTAL

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

Dietary Supplement: Nicotinamide Riboside (NR)

Placebo

OTHER

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

Other: Placebo

Interventions

Nicotinamide Riboside (NR) DIETARY_SUPPLEMENT

2000 mg NR daily.

Also known as: Nicotinamide adenine dinucleotide (NAD)

Nicotinamide Riboside (NR)

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Haukeland University Hospital: lead
• University of Bergen: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, Norway

RECRUITING

MeSH Terms

Interventions

nicotinamide-beta-riboside; NAD

Intervention Hierarchy (Ancestors)

Adenine Nucleotides; Purine Nucleotides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Coenzymes; Enzymes and Coenzymes; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Charalampos Tzoulis, PhD

  Haukeland University Hospital

  STUDY DIRECTOR

• Katarina Lundervold, MD

  University of Bergen

  PRINCIPAL INVESTIGATOR

• Janne Grønli, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Charalampos Tzoulis, PhD

CONTACT

55975061; charalampos.tzoulis@helse-bergen.no

Katarina Lundervold, MD

CONTACT

55975045; neurosysmedstudier@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Participants and all care providers and investigators are blinded during the trial and during data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized double-blinded placebo-controlled study with a duration of 8 weeks.

Study Record Dates

• First Submitted: April 28, 2025
• First Posted: May 14, 2025
• Study Start: October 13, 2025
• Primary Completion: May 1, 2026
• Study Completion: June 1, 2026
• Last Updated: September 15, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)