Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults

Condition(s) studied

Investigational drug(s) / intervention(s)

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: Placebo: Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime.

Study 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

Primary outcome measure(s)

• Objective Sleep Efficiency (%) — Baseline and Week 6
  Measured by wrist actigraphy over 14 consecutive days before intervention and during weeks 5-7 of supplementation.

Trial sites (1)

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