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Standardized Saffron Extract Formulation for Low Mood and Subclinical Depressive Symptoms: A Randomized,
Shishir Shah1, Nishesh Shah2, Jai Shah2
1Department of Product Development, Xtractiva Life Science Private Limited, Kochi, IND.
Cureus
|July 17, 2026
Summary
A standardized saffron extract (UO SAF 02) significantly improved mood and reduced depression symptoms in adults with low mood. This well-tolerated intervention also enhanced sleep quality and lowered cortisol levels.
Area of Science:
- Psychiatry and Mood Disorders
- Nutritional Psychiatry
- Clinical Psychology
Background:
- Low mood and subclinical depression are early stages of mood disorders, posing a risk for progression to major depression.
- Saffron extract has shown potential in managing mood-related symptoms.
- Evaluating novel interventions for early-stage mood disturbances is crucial for preventing disease progression.
Purpose of the Study:
- To assess the efficacy and safety of a standardized saffron extract formulation (UO SAF 02, 15 mg) in adults experiencing low mood and subclinical to mild depressive symptoms.
- To determine the impact of saffron extract on various psychological and physiological markers related to mood.
Main Methods:
- A randomized, double-blind, placebo-controlled trial involving 56 adults (aged 18-65) with self-reported low mood and Beck Depression Inventory (BDI) scores of 10-20.
- Participants received either UO SAF 02 (15 mg) or a placebo for 56 days.
- Primary outcome: change in Profile of Mood States (POMS) scores. Secondary outcomes: Positive and Negative Affect Schedule (PANAS), Depression Anxiety Stress Scales (DASS-21), Pittsburgh Sleep Quality Index (PSQI), and serum cortisol levels.
Main Results:
- UO SAF 02 demonstrated statistically significant improvements in POMS scores compared to placebo by Day 28, maintained through Day 56 (p < 0.0005).
- Significant enhancements were observed in positive affect, reductions in negative affect (p < 0.05), decreased depression, anxiety, and stress (DASS-21; p < 0.001), and improved sleep quality (PSQI; p < 0.05).
- Serum cortisol levels were significantly reduced in the saffron group at both Day 28 and Day 56 (p < 0.05), with no serious adverse events reported.
Conclusions:
- The standardized saffron extract UO SAF 02 effectively improved psychological and physiological mood-related outcomes in individuals with low mood.
- Saffron extract shows promise as a safe and well-tolerated intervention for mood regulation and managing early-stage depressive symptoms.
- These findings support the potential of UO SAF 02 as a therapeutic option for individuals experiencing subclinical to mild depressive symptoms.
