SleepSAFFRON-SLEEPNCT07497698
Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults
A study testing Saffron Extract in people with Sleep, run by Universidad de Granada at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Sleep
- What is being tested?
- Saffron Extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Universidad de Granada
Granada, Granada, 18016
Lucas Jurado Fasoli, +34618375662, juradofasoli@ugr.es
About this study
Official title: Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical 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.
Read the 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.
- Conditions
- Sleep
- Being tested
- Saffron Extract, Dietary Supplement: Placebo
- Keywords
- Saffron extract, Sleep quality, Insomnia, Actigraphy, Nutraceutical, Randomized clinical trial
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saffron ExtractDietary 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: PlaceboDietary supplement
Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime.
| Study group | Role | What they receive |
|---|---|---|
| Saffron Extract | Experimental | 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. Receives: Dietary Supplement: Saffron Extract |
| Placebo | Placebo comparator | Dietary Supplement: Placebo
Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime. Receives: Dietary Supplement: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Sleep Efficiency (%)
Measured by wrist actigraphy over 14 consecutive days before intervention and during weeks 5-7 of supplementation.
Measured: Baseline and Week 6
Secondary outcomes (10)
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.
Measured: Baseline and Week 6
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.
Measured: Baseline and Week 6
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.
Measured: Baseline and Week 6
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.
Measured: Baseline, Week 4, and Week 6
Insomnia Severity Index (ISI) Score
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.
Measured: Baseline, Week 4, and Week 6
Epworth Sleepiness Scale (ESS) Score
Daytime sleepiness assessed using the Epworth Sleepiness Scale (ESS). Total score ranges from 0 to 24, with higher scores indicating greater daytime sleepiness.
Measured: Baseline, Week 4, and Week 6
Heart Rate Variability (RMSSD and SDNN)
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.
Measured: Baseline and Week 6
Emotional State (BDI-FS, STAI, PSS-10 Scores)
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.
Measured: Baseline, Week 4, and Week 6
Health-Related Quality of Life (SF-36 Score)
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.
Measured: Baseline, Week 4, and Week 6
Biochemical Stress Markers (Cortisol, ACTH, Glucose, Insulin)
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.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Mar 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SleepStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either saffron extract (30 mg/day) or placebo for six weeks.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de Granada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lucas Jurado-Fasoli, Universidad de Granada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497698
- Sponsor's protocol ID
- SAFFRON-SLEEP-UGR-2025
- Acronym
- SAFFRON-SLEEP
- Status last verified
- Apr 2026
- First submitted
- 23 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data may be shared upon reasonable request and after approval by the principal investigator, in accordance with institutional and GDPR regulations.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Daily Saffron Extract Supplementation on Sleep Quality in Middle-Aged Adults: A Randomized, Triple-Blind, Placebo-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07497698
- Acronym / sponsor ID
- SAFFRON-SLEEP / SAFFRON-SLEEP-UGR-2025
- Conditions
- Sleep
- Keywords
- Saffron extract, Sleep quality, Insomnia, Actigraphy, Nutraceutical, Randomized clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Universidad de GranadaUniversity, hospital or other
- Study start
- 1 Mar 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 27 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned in a 1:1 ratio to receive either saffron extract (30 mg/day) or placebo for six weeks.
| Arm | Type | Receives |
|---|---|---|
| Saffron Extract | Experimental | Dietary Supplement: Saffron ExtractDietary 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. |
| Placebo | Placebo comparator | Dietary Supplement: Dietary Supplement: PlaceboDietary Supplement: Placebo Participants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saffron ExtractParticipants 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 | Saffron Extract |
| Dietary Supplement: PlaceboParticipants will receive identical capsules containing maltodextrin and excipients for six weeks, taken once daily one hour before bedtime. | Dietary supplement | Placebo |
Primary outcome
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data may be shared upon reasonable request and after approval by the principal investigator, in accordance with institutional and GDPR regulations.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Saffron Extract in people with Sleep, run by Universidad de Granada at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lucas Jurado-Fasoli, PhD (+34618375662, juradofasoli@ugr.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective Sleep Efficiency (%) (time frame: Baseline and Week 6). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.