Preprint / Version 1

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

Authors

  • Tora Mitra-Ganguli GSK Research and Development Centre, Haryana, India
  • Soumik Kalita GSK Research and Development Centre, Haryana, India
  • Sakshi Bhushan GSK Research and Development Centre, Haryana, India
  • Con Stough Swinburne Centre for Human Psychopharmacology, Swinburne University, Victoria, BC, Australia
  • James Kean Swinburne Centre for Human Psychopharmacology, Swinburne University, Victoria, BC, Australia
  • Nan Wang GSK Research and Development Centre, Haryana, India
  • Vidhu Sethi GSK Research and Development Centre, Haryana, India
  • Anuradha Khadilkar Jehangir Clinical Development Centre Pvt. Ltd., Jehangir Hospital Premises, Maharashtra, India

Keywords:

Bacopa monnieri extract, Brahmi, micronutrient supplementation, cognitive function, working memory, information processing, Indian, school children

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. Keywords: Bacopa monnieri extract, Brahmi, micronutrient supplementation, cognitive function, working memory, information processing, Indian, school children

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