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Standardized saffron extract (UO SAF 02) improves mood and sleep quality in adults with low mood and subclinical to mild depressive symptoms

In a randomized, double-blind, placebo-controlled trial, 56 adults with low mood and BDI scores of 10-20 received 15 mg of standardized saffron extract (UO SAF 02) or placebo for 56 days. The saffron group showed significant improvements in mood (POMS score reduction of -48.46 vs -5.67, p < 0.0005), sleep quality (PSQI, p < 0.05), and reduced serum cortisol levels (p < 0.05) compared to placebo.

Last updated: Jul 23, 2026•1 RCTs•📖 Read as article →

Evidence Score

Evidence Score44/100
Human RCT★★☆☆☆
Meta-analysis☆☆☆☆☆
Mechanism★★★★★
Safety★★★★☆
Confidencelow

Study Evidence

Study 1. Standardized Saffron Extract Formulation for Low Mood and Subclinical Depressive Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial.

observational

Shah S, Shah N, Shah J, S D, S J, Sudha Rani P · Cureus (2026)

Participants: N/A
Duration: 56 days
Intervention: 15 mg standardized saffron extract formulation (UO SAF 02) once daily for 56 days
Outcome: Profile of Mood States (POMS) total score, Positive and Negative Affect Schedule (PANAS), Depression Anxiety Stress Scales (DASS-21), Pittsburgh Sleep Quality Index (PSQI), serum cortisol levels
Effect Size: N/A (not reported in abstract)
Population: Adults aged 18-65 years with self-reported low mood and Beck Depression Inventory (BDI) scores of 10-20 (subclinical to mild depressive symptoms)

Result:

PubMed: 42465135DOI: 10.7759/cureus.110935

Mechanism Graph

Saffron extract modulates neurotransmitter systems (e.g., serotonin, dopamine)
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Reduces hypothalamic-pituitary-adrenal (HPA) axis activity
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Decreases serum cortisol levels
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Result: Improved mood and sleep quality

Limitations

  • ⚠Small sample size (n=56) limits generalizability
  • ⚠Short duration (56 days) does not assess long-term efficacy or safety
  • ⚠Self-reported low mood may introduce selection bias
  • ⚠No active comparator (e.g., standard antidepressant) was used

Frequently Asked Questions

What is UO SAF 02?▼

UO SAF 02 is a standardized saffron extract formulation, each capsule containing 15 mg of active compounds, tested for mood and sleep improvement in adults with subclinical depressive symptoms.

How was sleep quality measured in this study?▼

Sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-report questionnaire, and showed significant improvement in the saffron group compared to placebo (p < 0.05).

Is saffron extract safe for long-term use?▼

In this 56-day trial, no serious adverse events were reported, but longer-term safety beyond 8 weeks was not evaluated.

Can saffron extract replace antidepressants?▼

No, this study only tested saffron in individuals with subclinical to mild depressive symptoms (BDI 10-20), not major depression, and it should not replace prescribed medications without medical advice.

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References

  1. 1.Shah S, Shah N, Shah J, S D, S J, Sudha Rani P. "Standardized Saffron Extract Formulation for Low Mood and Subclinical Depressive Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial.." Cureus, 2026. PMID: 42465135 DOI: 10.7759/cureus.110935
Disclaimer: This content is for educational purposes only and is not medical advice. Evidence scores reflect the quality and quantity of available research, not clinical recommendations. Always consult a healthcare professional before starting any supplement or intervention.