Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults (SAFFRON-SLEEP)

University of Granada (UGR)

Status: Enrolling

Conditions: Sleep

Treatments: Dietary Supplement: Dietary Supplement: Placebo; Dietary Supplement: Saffron Extract

Study type: Interventional

Funder types: Other

Identifiers

NCT07497698

SAFFRON-SLEEP-UGR-2025

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Saffron Extract

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Saffron Extract

Placebo

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Dietary Supplement: Placebo