Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Saffron Extract, Dietary Supplement: Placebo.
- Who it may be relevant to
- Registry conditions: Sleep. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
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.
Detailed 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.
Interventions
- 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. - Dietary supplement Dietary Supplement: Placebo
Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime.
Primary outcome measures
- Objective Sleep Efficiency (%) [Time frame: Baseline and Week 6]
Secondary outcome measures (10)
- Total Sleep Time (hours) [Time frame: Baseline and Week 6]
- Wake After Sleep Onset (minutes) [Time frame: Baseline and Week 6]
- Sleep Latency (minutes) [Time frame: Baseline and Week 6]
- Pittsburgh Sleep Quality Index (PSQI) Score [Time frame: Baseline, Week 4, and Week 6]
- Insomnia Severity Index (ISI) Score [Time frame: Baseline, Week 4, and Week 6]
- Epworth Sleepiness Scale (ESS) Score [Time frame: Baseline, Week 4, and Week 6]
- Heart Rate Variability (RMSSD and SDNN) [Time frame: Baseline and Week 6]
- Emotional State (BDI-FS, STAI, PSS-10 Scores) [Time frame: Baseline, Week 4, and Week 6]
- Health-Related Quality of Life (SF-36 Score) [Time frame: Baseline, Week 4, and Week 6]
- Biochemical Stress Markers (Cortisol, ACTH, Glucose, Insulin) [Time frame: Baseline and Week 6]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Universidad de Granada — Granada
Identifiers
NCT: NCT07497698 · SAFFRON-SLEEP-UGR-2025