I. General Information & Product Quality
General Product & Origin
What is Affron® and which part of the plant is it extracted from?
Affron® is a standardized saffron extract (Crocus sativus L.) obtained exclusively from the flower stigmas, the part of the flower where most of the active compounds are found.
Where is Affron® manufactured and what is its origin?
Affron® is 100% manufactured at Pharmactive Biotech Products' facility in Madrid, Spain. Stigma raw material is sourced from high-quality cultivation areas operating under strict quality control and full traceability, ensuring the use of only the finest saffron stigmas.
What is the key active complex and how is Affron® standardized?
Affron® is standardized to Lepticrosalides® ≥3.5%, a patented totum of bioactives, mainly crocins and safranal.
Which extraction technology is used and what are the advantages?
The patented AFF®ON Cool-Tech process is a low-temperature, water-only extraction that preserves actives, is eco-friendly, lowers energy demand, and uses zero chemical solvents.
What is the shelf life of Affron®?
Affron® has a 36-month shelf life when stored sealed in the original container at room temperature (<25 °C), protected from light and humidity (<60% RH).
II. Clinical Efficacy, Dosage & Absorption
Clinical Efficacy & Use
What is the recommended daily dose (RDD)?
The usual RDD is 14 mg twice daily (total 28 mg/day). For sleep support, a single 14 mg dose about one hour before bedtime is also used.
How fast is Affron® absorbed?
Rapidly. In a pharmacokinetic study, the active metabolite crocetin was detected in blood as early as 60 minutes after ingestion.
What are the main clinically observed benefits?
Improvements in mood, reduction of occasional stress, and enhanced sleep quality/restorative sleep, plus support for menopausal well-being and sports performance.
Does Affron® work for sleep?
Yes. Significant improvements were observed within the first 7 days. A 14 mg dose one hour before bedtime seemed to increase endogenous melatonin.
Has Affron® been studied in adolescents?
Yes—28 mg/day for 8 weeks improved self-reported anxiety and depression in youths aged 12–16 with mild to moderate symptoms.
What about menopausal women?
28 mg/day for 12 weeks improved psychological aspects of menopause (~−33% anxiety, −32% low mood) with no undesired estrogenic effects reported.
Sports / physical activity?
Greater exercise enjoyment (stronger in men); in men, signals of increased parasympathetic activity (HRV).
III. Mechanisms of Action (MoA)
MoA How it works
How does Affron® physiologically improve sleep?
Promotes endogenous melatonin by directing tryptophan toward the melatonin pathway and limiting conversion to kynurenine.
Neurotransmitters & stress?
Balances serotonin and dopamine via reuptake inhibition, and supports GABAergic responses linked to sleep onset.
Cortisol / HPA axis?
In vivo data suggest reduced cortisol release and normalization of HPA-axis dysregulation under chronic stress.
Antioxidant / anti-inflammatory?
Lowers oxidative stress; increases HO-1, SOD-1, GSR, GPx-3; reduces IL-1β, TNF-α, IL-6 in liver and pineal gland.
IV. Safety & Interactions
Safety Tolerability & Use
Is Affron® safe and well tolerated?
Across 11 clinical trials with over 1,000 participants, adverse events were comparable to placebo.
Interactions with antidepressants?
No clinically relevant interactions reported; can be used adjunctively with antidepressants and may mitigate some side effects.
Age or pregnancy restrictions?
Adolescents (12–16) may use 28 mg/day. Not recommended under 12. Generally not advised during pregnancy or lactation due to limited formal safety data.
V. Other
Recognition Awards & Methodology
Awards or recognition?
Yes, among others, NutraIngredients USA 2020 (Cognitive Function), NutraIngredients Europe 2022 (Healthy Ageing), Frost & Sullivan 2020...
HPLC vs. UV (ISO 3632)?
HPLC-DAD is more specific/accurate than UV-Vis; UV often overestimates safranal and crocins.
Water-soluble?
Yes—aqueous, highly water-soluble; suitable for multiple applications including food matrices.
