Overview
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.
Description
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.
Eligibility
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
