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Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults

ConditionSleep
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversidad de Granada

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Severe neurological, psychiatric, or cardiovascular disorders

Diagnosed with obstructive sleep apnea, treated with CPAP

Night shift workers

Use of medications or supplements affecting sleep

Trial design

Design model

Parallel

Treatments tested in this trial

  • Saffron Extract

    Dietary supplement

    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

    Dietary supplement

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

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Saffron ExtractExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Objective Sleep Efficiency (%)

Measured by wrist actigraphy over 14 consecutive days before intervention and during weeks 5-7 of supplementation.

Time frame
Baseline and Week 6

Secondary outcomes

1

Total Sleep Time (hours)

Objectively measured total sleep time (in hours) assessed using wrist-worn triaxial accelerometry over 14 consecutive days. Data will be processed using validated algorithms integrating movement patterns and sleep diaries.

Time frame
Baseline and Week 6
2

Wake After Sleep Onset (minutes)

Wake After Sleep Onset (WASO), defined as the total number of minutes awake after initial sleep onset, measured objectively by wrist actigraphy over 14 consecutive days.

Time frame
Baseline and Week 6
3

Sleep Latency (minutes)

Sleep latency, defined as the time (in minutes) from reported bedtime to sleep onset, measured objectively using wrist-worn accelerometry and participant sleep logs.

Time frame
Baseline and Week 6
4

Pittsburgh Sleep Quality Index (PSQI) Score

Subjective sleep quality assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated questionnaire that evaluates sleep quality over the previous month. Total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.

Time frame
Baseline, Week 4, and Week 6

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universidad de Granada

Lead sponsor

Source ClinicalTrials.gov
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