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NCT Number: NCT07497698

Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults

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.

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Key information

Conditions

Sleep Dyssomnias Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Granada

Granada, 18016, Spain

Location status: Recruiting

Location contact

Lucas Jurado Fasoli

CONTACT

[email protected]

+34618375662

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Objective Sleep Efficiency (%)

    Time frame: Baseline and Week 6

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

Secondary outcomes

  1. Total Sleep Time (hours)

    Time frame: Baseline and Week 6

    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.

  2. Wake After Sleep Onset (minutes)

    Time frame: Baseline and Week 6

    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.

  3. Sleep Latency (minutes)

    Time frame: Baseline and Week 6

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

  4. Pittsburgh Sleep Quality Index (PSQI) Score

    Time frame: Baseline, Week 4, and Week 6

    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.

  5. Insomnia Severity Index (ISI) Score

    Time frame: Baseline, Week 4, and Week 6

    Severity of insomnia symptoms assessed using the Insomnia Severity Index (ISI). Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.

  6. Epworth Sleepiness Scale (ESS) Score

    Time frame: Baseline, Week 4, and Week 6

    Daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS). Total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.

  7. Heart Rate Variability (RMSSD and SDNN)

    Time frame: Baseline and Week 6

    Cardiac autonomic modulation assessed through heart rate variability (HRV) analysis under resting conditions. Time-domain parameters include RMSSD (root mean square of successive differences) and SDNN (standard deviation of normal-to-normal intervals), measured during a 5-minute stable segment.

  8. Emotional State (BDI-FS, STAI, PSS-10 Scores)

    Time frame: Baseline, Week 4, and Week 6

    Emotional status assessed using validated psychometric instruments:

    Beck Depression Inventory-Fast Screen (BDI-FS) State-Trait Anxiety Inventory (STAI) Perceived Stress Scale (PSS-10) Higher scores indicate greater depressive symptoms, anxiety, and perceived stress, respectively.

  9. Health-Related Quality of Life (SF-36 Score)

    Time frame: Baseline, Week 4, and Week 6

    Health-related quality of life assessed using the Short Form-36 Health Survey (SF-36), which evaluates physical and mental health domains. Scores are standardized from 0 to 100, with higher scores indicating better perceived health status.

  10. Biochemical Stress Markers (Cortisol, ACTH, Glucose, Insulin)

    Time frame: Baseline and Week 6

    Biochemical markers related to stress and metabolic function, including serum cortisol, adrenocorticotropic hormone (ACTH), fasting glucose, and insulin levels, obtained from clinical records and laboratory analyses.

Study contacts

Contact information is provided by the study sponsor or research team.

Lucas Jurado-Fasoli, PhD

CONTACT

[email protected]

+34618375662

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Official study title

Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial

Acronym: SAFFRON-SLEEP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Mar 27, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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