Saffron
Clinical studies on Safr'Inside™ extract
Unlike many saffron extracts available on the market, Safr'Inside™ is the subject of extensive studies, both preclinical and clinical, in order to precisely evaluate its efficacy and understand the mechanisms that support its action. Seven major research studies have been conducted by Activ'Inside, allowing Safr'Inside™ to be defined as an effective “adaptogen” for stress management and mood support.
An exceptional Sargol saffron and total traceability
Safr'Inside™ comes from the upper part (Sargol) of the stigma of the flower of Crocus sativus L., cultivated in Seno, in the province of Khorasan (Iran). This area benefits from a traditional irrigation system (the 2500-year-old Ghasabeh QANAT), guaranteeing optimal crop quality. The Sargol part is renowned for its high concentration of active metabolites (crocin, picrocin, safranal, etc.).
Multiple controls: To guarantee the purity of the extract, ten authenticity tests are carried out (DNA analysis, absence of synthetic safranal, absence of colorants, etc.).
Designation of origin: The saffron is directly imported to be standardized and concentrated using a proprietary process, ensuring consistency in the active ingredient composition.
Saffron 7x more active ingredients
Thanks to the Tech'Care extraction™ extraction method
7 studies that identified six adaptogenic mechanisms of action
The concept of adaptogen refers to a substance that helps the body better cope with various stresses (physical, emotional, environmental). In the case of Safr'Inside™, 7 studies (both ex vivo, in vivo and clinical) have highlighted 6 distinct mechanisms of action that you will find listed below.
1. Promotes serotonergic transmission: Ex vivo tests have shown that the extract protects and stimulates neurotransmission, including the release of serotonin (mood hormone) and dopamine (associated with pleasure).
2. Delays cortisol secretion: Measured in acute stress situations, Safr'Inside™ has demonstrated its ability to delay the “cortisol peak”, the stress hormone, thus helping the body to better resist stress.
3. Limits systemic inflammation: Ex vivo trials suggest an anti-inflammatory action, reducing pro-inflammatory cytokines in contexts of chronic stress.
4. Protects neurons against oxidative stress: Antioxidant compounds (crocin, safranal) contribute to the preservation of BDNF (Brain-Derived Neurotrophic Factor), essential for neuronal plasticity and good health of the nervous system.
5. Activates the parasympathetic nervous system: A clinical study measured heart rate variability (HRV) and observed that Safr'Inside™ helps maintain a more “relaxed” nervous balance in stressful situations.
6. Restores healthy gut flora: In vivo research has demonstrated the ability of Safr'Inside™ to support the growth of beneficial bacteria (notably Akkermansia), thereby improving the gut-brain axis and reducing anxiety-like behaviors.
A 56-day pivotal clinical trial (double-blind, randomized, controlled)
A clinical study was conducted on 56 healthy adults with a low mood. The objective: to evaluate the impact of Safr'Inside™ (30 mg/day, divided into two doses of 15 mg) on their mood and social well-being, for 56 days.
Study procedure:
• Population: 56 volunteers, randomized into two groups: Safr'Inside™ versus placebo.
• Duration: 56 days (8 weeks).
Measuring tools:
POMS-2 (Profile of Mood States 2) questionnaire, specifically assessing depression, anxiety and emotional tension.
WHOQOL (WHO Quality of Life) questionnaire, to assess the evolution of social relationships.
Urinary dosage of crocetin, a key metabolite of saffron, to verify the bioavailability of the extract.
The main results
Improvement in POMS-2 score – Depression : At the end of the trial, the Safr'Inside™ group showed a significant decrease in the “depression” score compared to the placebo.
Better social relationships : According to the WHOQOL scale, participants completing Safr'Inside™ felt more positive social interactions, marking an overall sense of well-being.
Proven bioavailability : As early as the 14th day of supplementation, crocetin levels in urine were significantly increased, establishing the good assimilation of the extract. In addition, a direct correlation was observed between the increase in crocetin and the decrease in the depression score.
Effectiveness in “acute intake” on the stress response
In the same study, a specific protocol evaluated the effect of Safr'Inside™ taken 30 minutes before a stress test: heart rate variability (HRV) was then measured to determine the physiological response to stress.
Key observations:
- Maintaining high HRV : The Safr'Inside™ group maintained a better balance between the sympathetic (accelerator) and parasympathetic (brake) nervous systems.
- Reduced tension : This greater cardiac “flexibility” translates into a calming effect and better stress management in real time.
Delayed cortisol secretion: the importance of synergy
Further analyses explored the effect of Safr'Inside™ and its main volatile compound, safranal, administered in isolation. While safranal demonstrates some impact on the stress response, the results are more pronounced with the complete Safr'Inside™ extract, highlighting the synergy between crocin, picrocin, safranal and all the micronutrients in saffron.
In practice:
- Cortisol measurement in an acute stress test.
- The rise in cortisol is delayed in subjects who received Safr'Inside™, improving resilience to stress.
Clinical studies on saffron in general
Saffron ( Crocus sativus L. ) is an ancient spice whose therapeutic use is attracting increasing interest in clinical research. Traditionally recognized for its health benefits, it has recently been the subject of studies highlighting its antioxidant, anti-inflammatory properties and its positive effects on mood. Numerous studies, ranging from double-blind randomized clinical trials to meta-analyses, have explored its effectiveness in the management of stress, anxiety and depression, as well as its potential in the treatment of certain specific pathologies such as attention deficit hyperactivity disorder (ADHD). This work provides precise insights into its mechanisms of action, thus confirming its promising role as a natural ally for mental well-being.
Clinical studies on saffron in general
Improved mood and well-being (Jackson et al., 2021)
In this randomized, double-blind, placebo-controlled study, healthy adults with subclinical feelings of low mood, anxiety, and/or stress were given 30 mg of saffron extract daily for 8 weeks. Researchers observed a significant improvement in emotional well-being as well as a decrease in depression scores. Interestingly, the results also showed an improvement in social relationships in participants receiving saffron, indicating a positive impact on the psychosocial sphere.
How the study was conducted:
- Participants were randomly assigned to the saffron group or the placebo group.
- Mental health effects (depression, anxiety, stress) were measured using validated questionnaires before, during and after the intervention.
- The researchers noted a significant difference between the two groups, with a more marked decrease in depressive symptoms in the saffron group.
The results obtained during the scientific study
- Decreased depression and anxiety scores.
- Improved emotional well-being and social relationships.
Antidepressant and anxiolytic properties (Shafiee et al., 2018)
This research looked at the antidepressant and anxiolytic effects of saffron by comparing its results to those of common medications. The study suggests that saffron has similar effects to common antidepressants, while causing fewer side effects. The team attributes these benefits to the presence of active compounds, including crocin and safranal.
How the study was conducted:
- Experimental model (here, on a model of postpartum depression in mice), supplemented by biochemical analyses on the CREB-BDNF pathway (involved in neuronal plasticity).
- Measurement of depressive and anxious behaviors according to standardized tests.
The results obtained
- Reduction of depressive and anxious behaviors.
- Better regulation of the CREB-BDNF pathway, linked to neurogenesis and mood maintenance.
Reduction in symptoms of depression and anxiety (Ghaderi et al., 2020)
In a meta-analysis of several randomized clinical trials, saffron ingestion showed a significant decrease in Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) scores, as well as an improvement in the Pittsburgh Sleep Quality Index (PSQI). C-reactive protein (CRP) levels, however, did not change, suggesting that the observed benefits were not related to a marked change in systemic inflammation.
How the study was conducted:
• Collection of different studies respecting strict methodological criteria.
• Integrated statistical analysis (meta-analysis) to evaluate the overall efficacy of saffron on depression, anxiety and sleep quality.
The results obtained
- Significant decrease in depressive and anxiety symptoms.
- Improved sleep quality.
- No notable impact on systemic inflammation measured by CRP.
Effectiveness in cases of major depression (Marxet al., 2019)
This study examined the effectiveness of saffron in the
treatment of major depression. Results indicate a reduction
notable reduction in depressive symptoms in participants receiving the extract
saffron, compared to the placebo group.
How the study was conducted:
- Randomized clinical trials in people diagnosed with major depressive disorder.
- Periodic assessment of the intensity of depressive symptoms.
The results obtained
- Marked decrease in depression scores, suggesting an efficacy of saffron at least comparable to some reference drug treatments, with a more favorable side effect profile.
Improved sleep quality (Lopresti etal., 2021)
Researchers have studied the link between the
Saffron consumption and sleep quality in adults. After supplementation, a notable improvement in sleep parameters (ease of falling asleep, less nighttime agitation, feeling rested upon waking) was observed.
was observed.
How the study was conducted:
- Double-blind, randomized, controlled trial.
- Measurement of sleep quality using questionnaires and, in some cases, specific analysis tools (actimetry, sleep diary).
Results :
- Significant improvement in sleep quality.
- Main hypothesis: positive influence of saffron on neurotransmitters involved in the regulation of the sleep-wake cycle.
Interest of saffron in ADHD in children and adolescents
Study 1: Crocus sativus L. VS Methylphenidate for children with ADHD (Baziar et al., 2019)
In this double-blind, randomized study, 54 children and adolescents aged 6 to 17 years, diagnosed with ADHD according to the
DSM-5 criteria, were divided into a group receiving saffron and a group receiving methylphenidate (Ritalin).
How the study was conducted:
- Subjects received either saffron or methylphenidate for several weeks.
- ADHD symptoms were assessed using standardized scales measuring attention, hyperactivity, and impulsivity.
Results :
- Similar efficacy for saffron and methylphenidate in reducing ADHD symptoms.
- Absence of notable side effects for the saffron group, suggesting a very favorable tolerance profile.
Study 2:
Blasco-Fontecilla et al. (2022)
In a non-randomized clinical study, 63 children and adolescents (7-17 years) received either methylphenidate (1 mg/kg/day) or 30 mg saffron for three months.
How the study was conducted:
- Measurement of ADHD symptoms and executive functions via specific scales and regular monitoring.
- Assessment of sleep quality and
possible side effects.
Results :
- Significant improvement in ADHD symptoms and executive functions in both groups.
- Saffron showed particularly marked efficacy in reducing hyperactivity, while methylphenidate appeared more suitable for reducing inattention.
- Both treatments increased total sleep time, but only saffron improved ease of falling asleep.
Sources des études mentionnées
Amélioration de l’humeur et du bien-être (Jackson et al., 2021)Propriétés antidépresseurs et anxiolytiques (Shafiee et al., 2018)Réduction des symptômes de dépression et d’anxiété (Ghaderi et al., 2020)Efficacité dans les cas de dépression majeure (Marxet al., 2019)Amélioration de la qualité du sommeil (Lopresti etal., 2021)