Effects of NAD Supplementation on Sleep Quality

NADream: Effects of Nicotinamide Adenine Dinucleotide Supplementation on Sleep Quality in Healthy Individuals: A Randomized Controlled Pilot Study

This study is testing if taking a supplement called NAD can help healthy adults aged 40 to 60 sleep better compared to a placebo.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 16 (estimated)
• Ages: 40 Years to 60 Years
• Sex: All
• Sponsor: Haukeland University Hospital (other)
• Locations: 1 site (Bergen)
• Trial ID: NCT06971224 on ClinicalTrials.gov

What this trial studies

This study evaluates the impact of nicotinamide adenine dinucleotide (NAD) supplementation, specifically in the form of nicotinamide riboside (NR), on sleep quality in healthy adults compared to a placebo. The research aims to determine whether NAD supplementation can enhance sleep by restoring the brain's neurophysiological capacity to rest. Participants aged 40 to 60 will receive either NAD or a placebo, and their sleep will be monitored using polysomnography and actigraphy to assess any differences in sleep quality and quantity. The study focuses on the potential benefits of NAD in improving mitochondrial function and reducing oxidative stress, which are crucial for healthy sleep.

Who should consider this trial

Good fit: Ideal candidates for this study are healthy adults aged 40 to 60 with normal sleep patterns and no history of sleep disorders.

Not a fit: Patients with existing sleep disorders or those currently using sleep medications or supplements may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved sleep quality for individuals through NAD supplementation.

How similar studies have performed: Other studies have shown promising results with NAD supplementation in various health aspects, but this specific approach to sleep quality is relatively novel.

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.

Where this trial is running

Bergen

• Haukeland University Hospital — Bergen, Norway (RECRUITING)

Study contacts

• Principal investigator: Katarina Lundervold, MD — University of Bergen
• Study coordinator: Charalampos Tzoulis, PhD

Conditions: Sleep, Nicotinamide Riboside, NR, Nicotinamide adenine dinucleotide, NAD, Polysomonography, PSG