Daily saffron extract for better sleep in middle-aged adults
Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
This trial will test whether taking 30 mg of saffron extract daily for six weeks improves sleep in middle-aged adults with mild-to-moderate sleep disturbances.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada, Granada) |
| Trial ID | NCT07497698 on ClinicalTrials.gov |
What this trial studies
This randomized, triple-blind, placebo-controlled trial will assign 80 adults aged 18–65 with mild-to-moderate sleep disturbances to receive 30 mg/day of standardized saffron extract or placebo for six weeks. Objective sleep will be measured with wrist-worn accelerometers (actigraphy) over 14 days before and during the final weeks of treatment, and participants will complete validated questionnaires for subjective sleep quality. Secondary outcomes include heart rate variability, cognitive processing speed, emotional state, perceived health status, and biochemical stress markers. The trial follows CONSORT guidelines and is conducted according to the Declaration of Helsinki and Good Clinical Practice.
Who should consider this trial
Good fit: Ideal participants are adults aged 18–65 with mild-to-moderate sleep disturbances, BMI 18–35 kg/m², not currently receiving pharmacological or psychological treatment for sleep, and willing to follow study procedures.
Not a fit: People with severe neurological, psychiatric, or cardiovascular disease, diagnosed obstructive sleep apnea treated with CPAP, night shift workers, those using sleep-affecting medications or supplements, pregnant or breastfeeding individuals, and those with uncontrolled medical conditions are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If effective, saffron supplementation could provide a low-risk, non-pharmacological option to improve sleep quality and daytime functioning in middle-aged adults.
How similar studies have performed: Small randomized and open-label studies have suggested saffron can modestly improve sleep and mood, but confirmatory large trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
Where this trial is running
Granada, Granada
- Universidad de Granada — Granada, Granada, Spain (Recruiting)
Study contacts
- Study coordinator: Lucas Jurado-Fasoli, PhD
- Email: juradofasoli@ugr.es
- Phone: +34618375662
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.