Efficacy of a Single Dose of Nicotinamide Riboside (NR) on Sleep: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in N3 Sleep Duration
研究概览
简要总结
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, 28 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. The primary outcome is the change in N3 sleep duration from the baseline night to the intervention night. Subjective sleep quality assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ), together with other objective sleep measures derived from PSG, will be evaluated as secondary outcomes.
详细描述
Sleep quality is a major component of overall health, yet many adults experience mild but persistent sleep difficulties. Nicotinamide riboside (NR) is a naturally occurring precursor of NAD+, a key coenzyme involved in cellular energy metabolism and circadian regulation. Preclinical studies suggest that NR may influence neural pathways related to sleep-wake control, but its short-term effects on human sleep have not been well established.
This study is designed to explore the acute impact of NR on sleep in healthy adults with mild subjective sleep complaints. It uses a randomized, double-blind, placebo-controlled design to minimize bias. All participants will spend two consecutive nights in a controlled sleep laboratory. The first night serves as a baseline assessment of natural sleep. On the second night, individuals will receive a single 600 mg dose of NR or a matched placebo one hour before bedtime.
Polysomnography (PSG) will be used to evaluate objective sleep parameters, with the prespecified primary outcome being the change in N3 (slow-wave) sleep duration from the baseline night to the intervention night. Secondary PSG outcomes include changes in total sleep time, sleep efficiency, sleep onset latency, wake after sleep onset, arousal frequency, N1, N2 and REM sleep durations, and REM sleep onset latency. Subjective sleep quality is assessed using the Leeds Sleep Evaluation Questionnaire (LSEQ) on the morning after the intervention night. Safety will be monitored throughout the study period and through a follow-up contact after discharge. This exploratory early-phase study aims to generate human data on the feasibility, safety, and acute effects of NR on both subjective and objective sleep-related measures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Nicotinamide Riboside (NR) Group
Participants randomized to this arm will receive a single oral dose of 600 mg NR approximately one hour before their second overnight PSG assessment.
干预措施: Nicotinamide Riboside (NR) (Dietary Supplement)
Placebo Group
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.
干预措施: Placebo (Other)
结局指标
主要结局
Change in N3 Sleep Duration
时间窗: Night 1 and Night 2
Change in the duration of N3 (slow-wave) sleep from the baseline night to the intervention night, measured by overnight PSG. The change is calculated as the N3 sleep duration on the intervention night minus the N3 sleep duration on the baseline night, in minutes.
Total Sleep Time (TST)
时间窗: Measured during the baseline night (pre-intervention) and the experimental night (post-NR or placebo).
Total amount of sleep obtained during the overnight PSG recording, measured in minutes.
次要结局
- Change in Total Sleep Time(Night 1 and Night 2)
- Change in Sleep Efficiency(Night 1 and Night 2)
- Change in Sleep Onset Latency(Night 1 and Night 2)
- Change in Wake After Sleep Onset(Night 1 and Night 2)
- Change in Arousal Frequency(Night 1 and Night 2)
- Change in N1 Sleep Duration(Night 1 and Night 2)
- Change in N2 Sleep Duration(Night 1 and Night 2)
- Change in REM Sleep Duration(Night 1 and Night 2)
- Change in REM Sleep Onset Latency(Night 1 and Night 2)
- Leeds Sleep Evaluation Questionnaire(Day 3 (morning after Night 2))
- 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).)