Acute Effects of Nicotinamide Riboside on Polysomnography-Measured Sleep Structure in Healthy Adults

NCT07284225 | Not Yet Recruiting DMC

• 1 other identifier: 2025287
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to evaluate whether a single oral dose of nicotinamide riboside (NR), a precursor of nicotinamide adenine dinucleotide (NAD+), has acute effects on sleep in healthy adults who report mild sleep difficulties. NR is widely used as a nutritional supplement and is known to increase cellular NAD+ levels, which may influence physiological processes linked to sleep-wake regulation. In this randomized, double-blind, placebo-controlled study, 20 healthy adults will complete two overnight sleep assessments using polysomnography (PSG), the gold-standard sleep monitoring method. After a baseline night of sleep recording, participants will receive either NR or a placebo before bedtime on the second night. Researchers will compare sleep duration and sleep structure before and after the intervention to determine whether NR has an acute effect on objective sleep quality. The study will also evaluate safety and collect participants' subjective sleep impressions. Findings may help clarify whether NR, a widely used nutritional supplement, has measurable short-term effects on human sleep.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• Total Sleep Time (TST)

  Total amount of sleep obtained during the overnight PSG recording, measured in minutes.

  Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo).

Secondary Outcomes (4)

• Sleep Latency

  Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo).

• Wake After Sleep Onset

  Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo).

• Sleep Stage Distribution

  Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo)

• Leeds Sleep Evaluation Questionnaire

  Morning of the day after the experimental night (approximately 8:00 AM).

Study Arms (2)

Nicotinamide Riboside (NR) Group

EXPERIMENTAL

Participants randomized to this arm will receive a single oral dose of 600 mg NR approximately one hour before their second overnight PSG assessment.

Dietary Supplement: Nicotinamide Riboside (NR)

Placebo Group

PLACEBO COMPARATOR

Participants randomized to this arm will receive a matching placebo capsule approximately one hour before their second overnight PSG assessment. The placebo is identical in appearance to the NR capsule and contains inert ingredients without active pharmacological effects.

Other: Placebo

Interventions

Nicotinamide Riboside (NR) DIETARY_SUPPLEMENT

A single oral dose of 600 mg NR, an NAD+ precursor compound, provided in capsule form. The dose and timing are standardized for all participants.

Nicotinamide Riboside (NR) Group

Placebo OTHER

The placebo capsule is visually identical to the NR capsule but contains inert excipients without active pharmacological components.

Placebo Group

Eligibility Criteria

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

You may qualify if:

• Healthy males or females aged 18 to 60 years inclusive;
• Screening using the Pittsburgh Sleep Quality Index (PSQI) scale with a total score between 5 and 10, indicating mild subjective sleep disturbance;
• Voluntarily participate in this study and sign a written informed consent form;
• Able to understand the study procedures and willing to comply with all laboratory regulations.

You may not qualify if:

• History of any serious neurological, cardiovascular, respiratory, hepatic, renal, hematological, or psychiatric disorders;
• Medically diagnosed sleep disorders (e.g., insomnia, sleep apnea syndrome, restless legs syndrome);
• Regular use within the past month of any medication or supplement that may affect sleep (e.g., sedatives, antidepressants, antihistamines, melatonin);
• Known allergy to nicotinamide riboside (NR) or any component of the study product;
• History of chronic smoking, heavy alcohol consumption (exceeding weekly recommended intake), or substance abuse;
• Participation in any other interventional clinical studies within one month prior to study initiation, or exposure to circadian rhythm-disrupting factors such as trans-time zone travel or frequent night shifts;
• Pregnant women, breastfeeding women, or men of reproductive age with plans to conceive within the next month who are not using effective contraception.

Sponsors & Collaborators

• Eye & ENT Hospital of Fudan University: lead

MeSH Terms

Interventions

nicotinamide-beta-riboside

Central Study Contacts

Shan Sun

CONTACT

+86-021-64377134-2033; sunshine7896@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2025
• First Posted: December 16, 2025
• Study Start: December 20, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: December 16, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share