Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Objective Sleep Efficiency (%)
研究概览
简要总结
This randomized, triple-blind, placebo-controlled clinical trial aims to evaluate the effects of daily saffron extract supplementation (30 mg/day) for six weeks on objective and subjective sleep quality in middle-aged adults with mild-to-moderate sleep disturbances. Secondary outcomes include heart rate variability, cognitive processing speed, emotional state, perceived health status, and biochemical stress markers.
详细描述
Sleep disturbances are highly prevalent in middle-aged adults and are associated with impaired daytime functioning, increased cardiometabolic risk, and reduced quality of life. Pharmacological treatments may be effective but are often associated with adverse effects and dependency risk.
Saffron (Crocus sativus L.) contains bioactive compounds such as crocins and safranal, which may modulate neurotransmitter systems involved in sleep regulation, including serotonin, dopamine, and GABA pathways.
Eighty middle-aged adults with mild-to-moderate sleep disturbances will be randomly assigned to receive either 30 mg/day of standardized saffron extract or placebo for six weeks. Sleep will be objectively assessed using wrist-worn accelerometry over 14 days before and during the final weeks of intervention. Subjective sleep quality will be evaluated using validated questionnaires.
The study follows CONSORT guidelines and will be conducted in accordance with the Declaration of Helsinki and Good Clinical Practice standards.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Saffron extract and placebo capsules will be identical in appearance, taste, packaging, and labeling. Allocation will be performed by an independent third party. Participants, investigators, care providers, and outcome assessors will remain blinded until study completion.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18-65 years
- •Mild-to-moderate sleep disturbances
- •BMI between 18 and 35 kg/m²
- •Not receiving active pharmacological or psychological treatment for sleep disorders
- •Willingness to comply with study procedures
排除标准
- •Severe neurological, psychiatric, or cardiovascular disorders
- •Diagnosed with obstructive sleep apnea, treated with CPAP
- •Night shift workers
- •Use of medications or supplements affecting sleep
- •Recreational drug use
- •Pregnancy or breastfeeding
- •Uncontrolled medical conditions
研究组 & 干预措施
Saffron Extract
Dietary Supplement: Saffron extract
Participants will receive 30 mg/day of standardized saffron extract (≥3% crocins; ≥2% safranal) for six weeks. Capsules will be taken once daily, one hour before bedtime.
干预措施: Saffron Extract (Dietary Supplement)
Placebo
Dietary Supplement: Placebo
Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime.
干预措施: Dietary Supplement: Placebo (Dietary Supplement)
结局指标
主要结局
Objective Sleep Efficiency (%)
时间窗: Baseline and Week 6
Measured by wrist actigraphy over 14 consecutive days before intervention and during weeks 5-7 of supplementation.
次要结局
- Total Sleep Time (hours)(Baseline and Week 6)
- Wake After Sleep Onset (minutes)(Baseline and Week 6)
- Sleep Latency (minutes)(Baseline and Week 6)
- Pittsburgh Sleep Quality Index (PSQI) Score(Baseline, Week 4, and Week 6)
- Insomnia Severity Index (ISI) Score(Baseline, Week 4, and Week 6)
- Epworth Sleepiness Scale (ESS) Score(Baseline, Week 4, and Week 6)
- Heart Rate Variability (RMSSD and SDNN)(Baseline and Week 6)
- Emotional State (BDI-FS, STAI, PSS-10 Scores)(Baseline, Week 4, and Week 6)
- Health-Related Quality of Life (SF-36 Score)(Baseline, Week 4, and Week 6)
- Biochemical Stress Markers (Cortisol, ACTH, Glucose, Insulin)(Baseline and Week 6)
研究者
Lucas Jurado-Fasoli
PhD
Universidad de Granada