A Randomized, Double-Blind Study Assessing Changes in Cognitive Function in Indian School Children Receiving a Combination of Bacopa monnieri and Micronutrient Supplementation vs. Placebo

Abstract

Several studies have indicated a chronic cognitive enhancing effect of Bacopa monnieri across different ages and cognitive impairment associated with vitamin and mineral deficiencies in children. Therefore, we investigated the effects of 4-month supplementation with a combination of B. monnieri extract and multiple micronutrients on cognitive functions in Indian school children aged 7–12 years. This was a randomized, double-blind, parallel design, single-center study in which 300 children were randomized to receive a beverage either fortified with B. monnieri and multiple micronutrients (“fortified”) or a non-fortified isocaloric equivalent (“control”) twice-daily for 4 months. Cognitive function was assessed by the Cambridge Neuropsychological Automated Test Battery (CANTAB) administered at baseline, Day 60 and Day 121. The primary endpoint was change in short-term memory (working memory) from baseline in subjects receiving “fortified” vs. “control” beverages after 4 months. Secondary endpoints included sustained attention, episodic memory, and executive function. The “fortified” beverage did not significantly improve short-term memory or any of the secondary outcomes tested relative to the “control” beverage. However, the spatial working memory “strategy” score showed significant improvement on Day 60 (difference between groups in change from baseline: −0.55; p < 0.05), but not on Day 121 due to the active intervention. Study products were well-tolerated. Reasons for these unexpected findings are discussed.

Bacopa monnieri (L.) Wettst. Extract Improves Memory Performance via Promotion of Neurogenesis in the Hippocampal Dentate Gyrus of Adolescent Mice

“…When 5-week-old mice were treated daily with BME for 7-28 days from day 0, significant enhancement of the spatial cognitive function in the modified Y-maze test occurred on day 7 but not on day 28. Notably, these results are consistent with clinical studies showing that supplementation with a combination of BME and multiple micronutrients to school children aged 7-12 years for 60 days but not 121 days significantly improved spatial working memory [19]. Furthermore, the treatment of neonatal rats with BME caused improvement in spatial memory performance and memory retention at 2-6 weeks after starting the administration [20].…”

“…Neurogenesis in the hippocampal dentate gyrus reportedly plays an important role in cognitive performance [19]. Based on the results described above, daily administration of BME (50 mg/kg/day, p.o.)…”

The Effect of a High-Dose Vitamin B Multivitamin Supplement on the Relationship between Brain Metabolism and Blood Biomarkers of Oxidative Stress: A Randomized Control Trial

“…Acute multivitamin supplementation has also been shown to improve contentment and cognitive task performance in adults [8]. In children, multivitamin supplementation for 12 weeks has been shown to increase intelligence [19] and cognitive performance, but not mood [6], whereas 4-month supplementation has been shown to have no effect on cognition [20]. These findings together demonstrate that multivitamin supplementation, particularly those higher in B vitamins, may improve cognition and mood, which might be facilitated by improving brain health, although more targeted investigations into the relationship between B vitamins and neuromarkers of health are required.…”

Bioactive Compounds and Traditional Herbal Medicine: Promising Approaches for the Treatment of Dementia

“…79 In contrast, a study reported that supplementation of Brahmi extract and multiple micronutrients twice daily for 4 months did not show a significant impact in improving short-term memory in Indian school children. 80 Despite the safety of Brahmi in animal studies and human trials, no studies regarding its safety in pregnancy, so it should not be used. 81,82…”