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Saffron Extract Supplementation and Sleep Quality in Middle-Aged Adults

NCT07497698 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-04-13

No results posted yet for this study

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

Interventions

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

Dietary Supplement: Placebo

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

Sponsors & Collaborators

  • Universidad de Granada

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-12-31
Completion
2027-06-01

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07497698 on ClinicalTrials.gov