Summary of results
- Improvement of hyperactivity more marked than under methylphenidate in certain studies (saffron), with a better sleep (sleep latency + duration).
- Reduction of attention deficits and agitation in 85–93% of children in studies using Bacopa monnieri.
- Decreased impulsivity and improved emotional control observed with choline and B vitamins (especially B6 and B12).
- Significant reduction in aggression, agitation and improved concentration thanks to the association magnesium + vitamin B6 (French studies).
- Improved mood and emotional well-being with saffron (antidepressant effect documented in ADHD and mild anxiety disorders)
- Improved digestive comfort and sleep thanks to specific probiotics (Bifidobacterium breve, Lactobacillus rhamnosus GG, B. longum 1714), having demonstrated an anxiolytic and neuroprotective effect.
- Experimental evidence of a causal link between altered microbiota and hyperactivity (ADHD microbiota transplantation inducing hyperactivity in animals).
Clinical studies on the Concentration and Serenity formula
Context
Attention deficit hyperactivity disorder (ADHD) is a common neurodevelopmental disorder in children, often treated with methylphenidate (Ritalin, Concerta, etc.). However, approximately 30 % of patients do not respond to psychostimulants or have limiting side effects) hence the interest in alternative or complementary therapies.
We evaluated an innovative nutraceutical formula, composed (per capsule) of saffron (20 mg), Bacopa monnieri (175 mg), choline bitartrate (160 mg), a vitamin B complex (B6 6 mg, B9 0.460 mg and B12 0.150 mg), vitamin D3 10 mg (1000 UI), magnesium (450 mg), zinc (3 mg) and a meprobiotic/pr diaperebiotics (10^10 CFU each of Lactobacillus rhamnosus GG, Bifidobacterium longum 1714, L. Helveticus R0052 + B. longum R0175, B. breve CCFM1025, plus prebiotic fibers (acacia gum, FOS and inulin).
A natural multimodal approach, acting on neurotransmitters, micronutritional status and the intestinal microbiota, can significantly reduce ADHD symptoms in children.
The tested formula could represent a promising alternative or complement to methylphenidate, particularly in patients intolerant to stimulants or wishing to reduce the dosage, subject to confirmation by larger-scale trials.
Attention deficit hyperactivity disorder (ADHD) affects approximately 5 to 7 % of school-aged children, manifesting as inappropriate levels of inattention, impulsivity, and hyperactivity. First-line treatment often relies on psychostimulants such as methylphenidate (Ritalin® or Concerta®), which target dopaminergic and noradrenergic neurotransmission.
These drugs provide a significant reduction in symptoms in approximately 70 % of patients (An open-label study to elucidate the effects of standardized Bacopa monnieri extract in the management of symptoms of attention-deficit hyperactivity disorder in children - PubMed)
However, they are associated with frequent side effects (loss of appetite, sleep disturbances, delayed height and weight growth, robot effect, etc.) and about a third of children cannot tolerate them or do not respond sufficiently to them (Improvement of neurobehavioral disorders in children supplemented with magnesium-vitamin B6. I. Attention deficit hyperactivity disorders - PubMed).
This motivates the search for alternative, more natural therapeutic strategies, aimed either at replacing stimulants or at reducing the necessary dose.
A better understanding of the pathophysiology of ADHD suggests that beyond prefrontal dopamine/norepinephrine deficit, other biological pathways may be involved : oxidative stress and neuronal inflammation, nutritional imbalances, dysregulation of the intestinal microbiota and the gut-brain axis, etc. (A possible link between early probiotic intervention and the risk of neuropsychiatric disorders later in childhood: a randomized trial - PubMed).
Furthermore, several nutrients and plant extracts have individually shown beneficial effects on ADHD symptoms or cognitive functions in clinical studies.
So we developed a formula combining three asset components complementary to target different mechanisms of ADHD :
(1) Concentration and Serenity Plants and amino acids – plant extracts and amino acids with pro-cognitive and anxiolytic properties (saffron, Bacopa monnieri), as well as cholinergic membrane precursors (phosphatidylserine, choline) to optimize neurotransmission ;
(2) Concentration and Serenity Vitamin and Mineral Supplements – essential nutrients often associated with the modulation of ADHD (magnesium, zinc, B vitamins, vitamin D) to correct possible deficiencies and support brain metabolism ;
(3) Concentration and Serenity Pre and Probiotics – specific probiotics and prebiotic fibers to act on the gut-brain axis, modulating neurointestinal inflammation, enteric neurotransmitter production and emotional state.
Each component of the formula was selected based on preclinical or clinical data suggesting an interest in ADHD or attentional functions.
Ingredients
Saffron, very fashionable at the moment, has been the subject of several clinical trials showing that saffron can reduce ADHD symptoms as effectively as methylphenidate, without causing the side effects typical of psychostimulants (Crocus sativus L. Versus Methylphenidate in Treatment of Children with Attention-Deficit/Hyperactivity Disorder: A Randomized, Double-Blind Pilot Study - PubMed) +(New horizons for the study of saffron (Crocus sativus L.) and its active ingredients in the management of neurological and psychiatric disorders: A systematic review of clinical evidence and mechanisms - PubMed)
A 2022 Spanish study concluded that it was as effective as Ritalin; saffron improved hyperactivity more, while Ritalin worked more on inattention.In addition, saffron significantly improves sleep (falling asleep + duration) Efficacy of saffron extract (Saffr'Activ) in the treatment of children and adolescents with attention-deficit/hyperactivity disorder (ADHD): a clinical efficacy study
Other studies have shown that the combination of methylphenidate and saffron led to a faster and more marked improvement in symptoms from the 4th week, without adverse effects.
(A comparison of methylphenidate (MPH) and methylphenidate combined with Crocus sativus (saffron) in the treatment of children and adolescents with ADHD: a randomized, double-blind, parallel-group clinical trial) + (Pazoki Et Al. 2022 - Efficacy and Safety of Saffron As Adjunctive Therapy in Adults With ADHD | PDF | Attention Deficit Hyperactivity Disorder | Antidepressant)
A randomized, double-blind, placebo-controlled study showed that saffron extract supplementation (30 mg/day for 8 weeks) significantly improved emotional well-being in healthy adults with subclinical signs of stress, anxiety, or low mood. The study also found decreased depression scores and improved social relationships at the end of the protocol, suggesting a beneficial effect of saffron on mild depressive symptoms in undiagnosed individuals, which may incidentally improve ADHD symptoms. (Jackson et al., “Saffron Supplementation Improves Emotional Well-Being in Adults with Subclinical Feelings of Anxiety and Stress: A Randomized, Double-Blind, Placebo-Controlled Study” (2021)
In conclusion, saffron is effective in eclinical studies, with a toleranceefavorable rance. It'withere mesynergistic with the methylphenidate when'it is usede in association, in particular for the'hyperactivitye and sleep.
However, the size recollection of esamples and lack of diversitye : single-center trials in Iran (1er world producer of saffron) limit the porteand conclusions. More robust trials are essential to confirm these data.ees.
THE Bacopa monnieri is an Ayurvedic nootropic reputed to improve memory and attention. An open-label study in children aged 6–12 years has shown that a standardized extract of Bacopa (225 mg/day for 6 months) significantly reduced hyperactivity, inattention, and impulsivity in 85–93 % of participants (An open-label study to elucidate the effects of standardized Bacopa monnieri extract in the management of symptoms of attention-deficit hyperactivity disorder in children - PubMed) + Effectiveness of different supplements in alleviating ADHD symptoms with or without stimulant use: a systematic review - PubMed
Parents reported a decrease in symptoms of restlessness (motor agitation) in 93 % of cases and better self-control in 89 % (An open-label study to elucidate the effects of standardized Bacopa monnieri extract in the management of symptoms of attention-deficit hyperactivity disorder in children - PubMed).
Bacopa exerts neuroprotective, anti-inflammatory effects and may increase cholinergic neurotransmission, supporting its use to support cognitive functions in ADHD.
There choline (choline bitartrate, 40 mg providing 16 mg of choline). Choline is a precursor to acetylcholine, a neurotransmitter involved in attention and memory processes. Research has shown that supplementing with citicoline (CDP-choline form) improves psychomotor speed, selective attention, and reduces impulsivity in adolescents, even without ADHD (Cognizin Dietary Supplement May Improve Attention in Teen Boys)
In a double-blind study, boys who took 250–500 mg/day of citicoline for 28 days performed better on cognitive tests (Ruff 2&7, CPT-II) compared to placebo (Cognizin Dietary Supplement May Improve Attention in Teen Boys
The addition of choline in our formula therefore aims to support acetylcholine synthesis and cognitive function, which could contribute to concentration and working memory in young people with ADHD.
Several vitamins and minerals have been integrated to optimize brain metabolism and compensate for possible deficiencies often reported in children with ADHD.
According to studies, children receiving micronutrient-rich formula were three times more likely to have improved concentration and mood (54 % vs 18 % for placebo)
(Vitamins, minerals improve symptoms for children with ADHD | OHSU News)
Multivitamin-mineral supplementation reduced aggression and improved emotional regulation over 10 weeks, with a good safety profile (https://www.mdpi.com/2072-6643/17/9/1482?utm_source=chatgpt.com)
THE magnesium (450 mg in highly bioavailable form, bisglycinate or citrate) is an essential cofactor involved in more than 300 enzymatic reactions, including those of neurotransmission (it regulates NMDA receptors and the release of neurotransmitters). Studies have found that many ADHD children have suboptimal magnesium status, particularly low intraerythrocyte magnesium (Improvement of neurobehavioral disorders in children supplemented with magnesium-vitamin B6. I. Attention deficit hyperactivity disorders - PubMed).
A small French study showed that combined magnesium-vitamin B6 supplementation (6 mg/kg Mg and 0.6 mg/kg B6 for 8 weeks) significantly improved hyperactivity, aggression and academic attention in 40 ADHD children (Improvement of neurobehavioral disorders in children supplemented with magnesium-vitamin B6. I. Attention deficit hyperactivity disorders - PubMed)
Symptoms improved (decreased hyperactivity and improved attention) in parallel with an increase in intraerythrocyte Mg, and recurred when treatment was stopped (Improvement of neurobehavioral disorders in children supplemented with magnesium-vitamin B6. I. Attention deficit hyperactivity disorders - PubMed).
This result suggests that magnesium intake (supported by vitamin B6 which promotes its cellular entry) can reduce neuromuscular and central hyperexcitability in these patients
In our formula, the vitamin B6 is provided in moderate doses (6 mg in active form pyridoxal-5-phosphate) in synergy with magnesium, to support the synthesis of neurotransmitters such as serotonin, dopamine and GABA whose production depends on B6.
There vitamin B9 and the B12 are included to ensure adequate folate and cobalamin status, which are essential for the metabolism of monoamines via the methylation cycle.
Insufficient folate/B12 levels can lead to elevated homocysteine and neurodevelopmental dysfunction.
Although no studies have shown that isolated B9/B12 supplementation improves ADHD, it is rational to correct any deficiency to optimize overall brain function.
Additionally, a 2019 meta-analysis showed that vitamin supplementation D in ADHD children treated with Ritalin provided a small additional benefit on symptoms (The Effect of Vitamin D Supplementation on Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials - PubMed).
Four controlled trials (n=256) reported that adding 1000–2000 IU/d of vitamin D3 for 8–12 weeks modestly reduced total ADHD and hyperactivity scores compared to placebo (The Effect of Vitamin D Supplementation on Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials - PubMed).
The mean difference, although statistically significant, was small in magnitude, reflecting a small but real clinical improvement without notable adverse effects (The Effect of Vitamin D Supplementation on Attention-Deficit/Hyperactivity Disorder: A Systematic Review and Meta-Analysis of Randomized Controlled Trials - PubMed)
Vitamin D plays a neurosteroidal role, influencing synaptic plasticity and the production of neurotransmitters such as dopamine (Vitamin D for ADHD? | 2020-10-30 - The Carlat Report).
Furthermore, it has been found that the majority of ADHD children have insufficient vitamin D status, correlated with the severity of comorbid disorders (anxiety, sleep disorders) (Nutrition in the Management of ADHD: A Review of Recent Research | Current Nutrition Reports ). So, we included 1000 IU of vitamin D3 to normalize vitamin D status, which could indirectly promote better behavioral and sleep regulation.
THE zinc is a crucial trace element for many brain enzymes, modulation of NMDA and GABA receptors, as well as dopamine metabolism.
A meta-analysis confirmed that children with ADHD tend to have lower serum zinc levels than controls, suggesting that marginal zinc deficiency may contribute to symptoms (Zinc status in attention-deficit/hyperactivity disorder - Nature).
Clinical trials, particularly in the Middle East where zinc deficiency is more common, have indicated that zinc supplementation may improve ADHD symptoms.
For example, a double-blind trial in 44 children showed that zinc sulfate monotherapy (150 mg/day) for 12 weeks significantly reduced hyperactivity, impulsivity and irritability compared to placebo (Double-blind, placebo-controlled study of zinc sulfate in the ...). More recently, a systematic review of 6 RCTs (489 children) concluded that zinc supplementation provides a moderate overall benefit on total ADHD symptoms (pooled SMD = –0.62, p = 0.04 compared to placebo) (The effect of zinc supplementation in children with attention deficit hyperactivity disorder: A systematic review and dose-response meta-analysis of randomized clinical trials - PubMed).
Although the heterogeneity of the studies is high and the specific impact on inattention vs. hyperactivity remains to be clarified, these data support zinc intake as an adjuvant in the management of ADHD (The effect of zinc supplementation in children with attention deficit hyperactivity disorder: A systematic review and dose-response meta-analysis of randomized clinical trials - PubMed) + Iron, magnesium, vitamin D, and zinc deficiencies in children with symptoms of attention-deficit/hyperactivity disorder - PubMed
In our formula, 6 mg of zinc (maximum limit set by the DGCCRF for children under 10 years old) is enough to correct a slight deficiency without risking overload.
Finally, the component Pre and Probiotics of the formula aims to harness the microbiota-gut-brain axis in ADHD. Emerging studies suggest that the gut microbiota may influence behavior and brain function via the production of neuroactive metabolites (short-chain fatty acids, neurotransmitters such as GABA, serotonin), modulation of immunity and systemic inflammation, as well as via the vagus nerve.
In animals, fecal microbiota transplants from ADHD patients induce hyperactivity, suggesting a possible causal role of dysbiotic microbiota.
Clinically, a landmark Finnish trial followed children given a probiotic Lactobacillus rhamnosus GG (LGG) during early childhood : at the age of 13 years, none of the children in the probiotic group had developed ADHD, compared to 17 % in the placebo group (A possible link between early probiotic intervention and the risk of neuropsychiatric disorders later in childhood: a randomized trial - PubMed).
Although the sample size was small (n=75), this pioneering result raises the hypothesis that an early modulated microbiota could lower the risk of neurodevelopmental disorders.
Furthermore, a recent pilot study administering a mixture of probiotics to children already diagnosed (probiotics targeting the production of dopamine and GABA, Lactobacillus plantarum And L. brevis) did not observe a significant difference vs. placebo in the entire sample, but noted an improvement in hyperactivity/impulsivity in the youngest ADHD children on probiotics (effect size d = 0.69) (L-theanine for ADHD: Potential benefits, dosage, risks, and more) ( Effect of Probiotics on the Symptomatology of Autism Spectrum Disorder and/or Attention Deficit/Hyperactivity Disorder in Children and Adolescents: Pilot Study - PMC ).
Similarly, intestinal problems, common in people with ADHD, and quality of life improved further with probiotics in children with comorbid autism spectrum disorders ( Effect of Probiotics on the Symptomatology of Autism Spectrum Disorder and/or Attention Deficit/Hyperactivity Disorder in Children and Adolescents: Pilot Study - PMC ). These exploratory results encourage further research into optimal probiotic strains for ADHD.
Our formula includes specific probiotic strains that have shown psychotropic effects in previous studies on stress, anxiety or sleep.
Lactobacillus rhamnosus GG, one of the most documented probiotic strains, improves the intestinal barrier and favorably modulates the immune response.
In healthy volunteers, consumption of B.longum 1714 for 4 weeks reduced perceived levels of stress and improved some measures of visuospatial memory (Psychobiotics: Mechanisms of Action, Evaluation Methods and ...).
EEG recordings suggest that this strain may induce a brain state more resilient to social stress (One Giant Leap from Mouse to Man: The Microbiota–Gut–Brain Axis ...).
Finally, Bifidobacterium breve CCFM1025 is an emerging strain initially studied in China for its effects on depression and insomnia. A 2023 randomized trial showed that B. breve CCFM1025 (5×10^9 CFU/day) for 4 weeks improved sleep quality (reduction in PSQI score) in adults with stress-related insomnia, compared to placebo (Bifidobacterium breve CCFM1025 Improves Sleep Quality via ...).
Animal models suggest that this strain exerts an antidepressant effect by favorably modifying the composition of the microbiota and the metabolism of tryptophan to serotonin (Environmental enrichment in combination with Bifidobacterium ...) (Probiotics for the treatment of depression and its comorbidities).
In the context of ADHD, where insomnia and dysphoric mood are common comorbidities, B. breve CCFM1025 can be expected to contribute to better sleep and improved mood, thereby indirectly supporting symptom management.
Conclusion
The “3 in 1” formula that we offer is based on ingredients that have individually shown an interest in the management of ADHD or its associated dimensions (attention, behavior, anxiety, sleep).
The hypothesis is that by combining these synergistic active ingredients, clinically significant improvement in ADHD symptoms, potentially comparable to standard treatments, could be achieved while minimizing adverse effects.
The effectiveness of this approach may vary depending on the profile. Medical advice is essential before any supplementation with Concentration & Serenity.