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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Saffron Extract | Experimental | 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. |
|
| Placebo | Placebo Comparator | Dietary Supplement: Placebo Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Saffron Extract | Dietary Supplement | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Sleep Efficiency (%) | Measured by wrist actigraphy over 14 consecutive days before intervention and during weeks 5-7 of supplementation. | Baseline and Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Total Sleep Time (hours) | Objectively measured total sleep time (in hours) assessed using wrist-worn triaxial accelerometry over 14 consecutive days. Data will be processed using validated algorithms integrating movement patterns and sleep diaries. | Baseline and Week 6 |
| Wake After Sleep Onset (minutes) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lucas Jurado-Fasoli, PhD | Contact | +34618375662 | juradofasoli@ugr.es |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidad de Granada | Recruiting | Granada | Granada | 18016 | Spain |
De-identified individual participant data may be shared upon reasonable request and after approval by the principal investigator, in accordance with institutional and GDPR regulations.
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| ID | Term |
|---|---|
| D007319 | Sleep Initiation and Maintenance Disorders |
| ID | Term |
|---|---|
| D020919 | Sleep Disorders, Intrinsic |
| D020920 | Dyssomnias |
| D012893 | Sleep Wake Disorders |
| D009422 | Nervous System Diseases |
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Participants will be randomly assigned in a 1:1 ratio to receive either saffron extract (30 mg/day) or placebo for six weeks.
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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.
| Dietary Supplement: Placebo | Dietary Supplement | Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime. |
|
Wake After Sleep Onset (WASO), defined as the total number of minutes awake after initial sleep onset, measured objectively by wrist actigraphy over 14 consecutive days. |
| Baseline and Week 6 |
| Sleep Latency (minutes) | Sleep latency, defined as the time (in minutes) from reported bedtime to sleep onset, measured objectively using wrist-worn accelerometry and participant sleep logs. | Baseline and Week 6 |
| Pittsburgh Sleep Quality Index (PSQI) Score | Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that evaluates sleep quality over the previous month. Total score ranges from 0 to 21, with higher scores indicating poorer sleep quality. | Baseline, Week 4, and Week 6 |
| Insomnia Severity Index (ISI) Score | Severity of insomnia symptoms assessed using the Insomnia Severity Index (ISI). Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity. | Baseline, Week 4, and Week 6 |
| Epworth Sleepiness Scale (ESS) Score | Daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS). Total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness. | Baseline, Week 4, and Week 6 |
| Heart Rate Variability (RMSSD and SDNN) | Cardiac autonomic modulation assessed through heart rate variability (HRV) analysis under resting conditions. Time-domain parameters include RMSSD (root mean square of successive differences) and SDNN (standard deviation of normal-to-normal intervals), measured during a 5-minute stable segment. | Baseline and Week 6 |
| Emotional State (BDI-FS, STAI, PSS-10 Scores) | Emotional status assessed using validated psychometric instruments: Beck Depression Inventory-Fast Screen (BDI-FS) State-Trait Anxiety Inventory (STAI) Perceived Stress Scale (PSS-10) Higher scores indicate greater depressive symptoms, anxiety, and perceived stress, respectively. | Baseline, Week 4, and Week 6 |
| Health-Related Quality of Life (SF-36 Score) | Health-related quality of life assessed using the Short Form-36 Health Survey (SF-36), which evaluates physical and mental health domains. Scores are standardized from 0 to 100, with higher scores indicating better perceived health status. | Baseline, Week 4, and Week 6 |
| Biochemical Stress Markers (Cortisol, ACTH, Glucose, Insulin) | Biochemical markers related to stress and metabolic function, including serum cortisol, adrenocorticotropic hormone (ACTH), fasting glucose, and insulin levels, obtained from clinical records and laboratory analyses. | Baseline and Week 6 |
| D001523 |
| Mental Disorders |