Daily saffron extract for better sleep in middle-aged adults
Official title: Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
Run by Universidad de Granada · NCT07497698 · Data updated 2026-11-12
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
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 80 (estimated) |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada, Granada) |
| Status | Recruiting |
| Started | March 1, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | June 1, 2027 |
| Registry record updated | April 13, 2026 |
| Trial ID | NCT07497698 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Small randomized and open-label studies have suggested saffron can modestly improve sleep and mood, but confirmatory large trials are limited.
Who can join: the full rules
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 it's running
-
Universidad de Granada
Granada, Granada, Spain Recruiting
Study contacts
- Study coordinator: Lucas Jurado-Fasoli, PhD
- Email: juradofasoli@ugr.es
- Phone: +34618375662
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.