08.05.21
Natural Remedies has obtained two Natural Product Numbers (NPN) from Health Canada for the company’s BacoMind brand of Bacopa monnieri.
The first (#80111110) is for BacoMind Children. It carries the claims: “Helps to support cognitive function in children,” and “Helps to support brain health in children.” The recommended dosage is 225 mg per day for children and teens (aged 6 to 18).
The second NPN (#80111109) is for BacoMind Adult, carrying the claims: “Supports brain health”; “Helps to support cognitive health and brain performance”; and “Helps to support memory.” The recommended doses for adults is 300 to 450 mg per day.
“BacoMind is a true full-spectrum Bacopa monnieri extract with nine bioactives that synergize to promote cognitive wellness and neurological health and is also the first Bacopa to be GRAS,” said Deepak Mundkinajeddu, PhD, head of R&D at Natural Remedies.
BacoMind is supported by five human clinical studies in adults and children (including a human clinical safety study), which served as the basis for Health Canada’s approval, according to Abey Thomas, head of global marketing for Natural Remedies.
The studies are as follows:
1) 98 healthy elderly participants consuming 300 mg BacoMind per day for 12 weeks showed improved memory acquisition and retention. (Morgan and Stevens. Journal of Alternative and Complimentary Medicine 2010, 16 : 753-759)
2) 65 elderly participants consumed 450 mg BacoMind daily for 12 weeks and observed at both week 12 and 12 weeks post-supplementation had improved verbal memory. (Barbhaiya et al. Journal of Pharmacology and Toxicology 2008, 3: 425-434)
3) 24 children requiring individual education programs who took 225 BacoMind daily for four months showed improvement in battery of memory tests. (Usha et al. Journal of Pharmacology and Toxicology 2008, 3(4): 302-310)
4) 27 children with ADHD who took 225 mg BacoMind per day for six months had significant reduction in six of seven ADHD symptoms. (Dave et al. Advances in Mind-Body Medicine 2014, 28(2):10-5)
5) 23 healthy adults who took 300 mg BacoMind per day for 15 days followed by 450 mg per day for the next 15 days were evaluated for adverse effects; the researchers found that BacoMind is safe for human consumption.
Mundkinajeddu explained the mechanisms of action of BacoMind likely responsible for the efficacy seen in the human clinical studies. Based on the original work done on BacoMind, it’s actions on neurotransmission are likely mediated through inhibition of COMT and PEP, its neuroprotective actions have contributions through inhibition of ROS and PARP. In addition to these biochemical mechanisms, it has also been shown to promote dendrite proliferation indicating possibilities of beneficial neuronal morphological changes.
“Because BacoMind is GRAS, its use in popular food and beverage products is possible and helps brands attain unique market positioning,” Thomas said. “For example, BacoMind can be used in gluten-free and vegan (or conventional) bakery products at 50 mg per serving, as well as in gummies and chews.”
The first (#80111110) is for BacoMind Children. It carries the claims: “Helps to support cognitive function in children,” and “Helps to support brain health in children.” The recommended dosage is 225 mg per day for children and teens (aged 6 to 18).
The second NPN (#80111109) is for BacoMind Adult, carrying the claims: “Supports brain health”; “Helps to support cognitive health and brain performance”; and “Helps to support memory.” The recommended doses for adults is 300 to 450 mg per day.
“BacoMind is a true full-spectrum Bacopa monnieri extract with nine bioactives that synergize to promote cognitive wellness and neurological health and is also the first Bacopa to be GRAS,” said Deepak Mundkinajeddu, PhD, head of R&D at Natural Remedies.
BacoMind is supported by five human clinical studies in adults and children (including a human clinical safety study), which served as the basis for Health Canada’s approval, according to Abey Thomas, head of global marketing for Natural Remedies.
The studies are as follows:
1) 98 healthy elderly participants consuming 300 mg BacoMind per day for 12 weeks showed improved memory acquisition and retention. (Morgan and Stevens. Journal of Alternative and Complimentary Medicine 2010, 16 : 753-759)
2) 65 elderly participants consumed 450 mg BacoMind daily for 12 weeks and observed at both week 12 and 12 weeks post-supplementation had improved verbal memory. (Barbhaiya et al. Journal of Pharmacology and Toxicology 2008, 3: 425-434)
3) 24 children requiring individual education programs who took 225 BacoMind daily for four months showed improvement in battery of memory tests. (Usha et al. Journal of Pharmacology and Toxicology 2008, 3(4): 302-310)
4) 27 children with ADHD who took 225 mg BacoMind per day for six months had significant reduction in six of seven ADHD symptoms. (Dave et al. Advances in Mind-Body Medicine 2014, 28(2):10-5)
5) 23 healthy adults who took 300 mg BacoMind per day for 15 days followed by 450 mg per day for the next 15 days were evaluated for adverse effects; the researchers found that BacoMind is safe for human consumption.
Mundkinajeddu explained the mechanisms of action of BacoMind likely responsible for the efficacy seen in the human clinical studies. Based on the original work done on BacoMind, it’s actions on neurotransmission are likely mediated through inhibition of COMT and PEP, its neuroprotective actions have contributions through inhibition of ROS and PARP. In addition to these biochemical mechanisms, it has also been shown to promote dendrite proliferation indicating possibilities of beneficial neuronal morphological changes.
“Because BacoMind is GRAS, its use in popular food and beverage products is possible and helps brands attain unique market positioning,” Thomas said. “For example, BacoMind can be used in gluten-free and vegan (or conventional) bakery products at 50 mg per serving, as well as in gummies and chews.”
