Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults

NCT07497698 | Recruiting

• 1 other identifier: SAFFRON-SLEEP-UGR-2025
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sleep

Keywords

Saffron extract; Sleep quality; Insomnia; Actigraphy; Nutraceutical; Randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Objective Sleep Efficiency (%)

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

  Baseline and Week 6

Secondary Outcomes (10)

• Total Sleep Time (hours)

  Baseline and Week 6

• Wake After Sleep Onset (minutes)

  Baseline and Week 6

• Sleep Latency (minutes)

  Baseline and Week 6

• Pittsburgh Sleep Quality Index (PSQI) Score

  Baseline, Week 4, and Week 6

• Insomnia Severity Index (ISI) Score

  Baseline, Week 4, and Week 6

Study Arms (2)

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.

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.

Dietary Supplement: Dietary Supplement: Placebo

Interventions

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.

Saffron Extract

Dietary Supplement: Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Universidad de Granada

Granada, Granada, 18016, Spain

RECRUITING

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Lucas Jurado-Fasoli, PhD

CONTACT

+34618375662; juradofasoli@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Saffron extract and placebo capsules will be identical in appearance, taste, packaging, and labeling. Allocation will be performed by an independent third party. Participants, investigators, care providers, and outcome assessors will remain blinded until study completion.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either saffron extract (30 mg/day) or placebo for six weeks.

Study Record Dates

• First Submitted: March 23, 2026
• First Posted: March 27, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 13, 2026

Record last verified: 2026-04

Locations

ES (1)