Saffron Extract Supplementation and Sleep Quality 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
Universidad de Granada
80 participants
Mar 1, 2026
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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 Criteria7
- 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
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Interventions
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.
Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07497698