Effect of Bacopa monnieri Extract on Memory and Cognitive Skills in Adult Humans: A Randomized, Double-Blind, Placebo-Controlled Study

Abstract

Introduction: Age-related cognitive decline affects quality of life and freedom during old age. Early interventions help to maintain normal and healthy cognitive aging. Bacopa monnieri is known for its memory-enhancing properties and used widely to improve cognitive functions. This study reports safety and efficacy of B. monnieri extract (BME) on memory and cognitive functions in healthy adults. Methods: Eighty healthy subjects (40 per group) were evaluated in this randomized, double-blind, placebo-controlled, parallel group study. Subjects consumed either 300 mg of BME containing 90 mg of total bacosides or placebo every morning after breakfast for 12 weeks. Memory (baseline, Days 28, 56 and 84) and cognitive functions (baseline, Days 1, 14, 28, 56 and 84) were measured using Creyos battery of tests; anxiety and sleep quality were assessed by Beck Anxiety Inventory and Pittsburgh Sleep Quality Index, respectively at baseline, Days 28, 56 and 84. Brain Derived Neurotrophic Factor (baseline and Day 84) and cortisol levels (baseline, Days 56 and 84) were analyzed in serum samples. Safety was assessed throughout the study based on physical examination, vital signs, clinical laboratory tests and monitoring of adverse events. Results: Thirty-six subjects from placebo group and 38 subjects from BME group completed the study. BME group showed significant improvements on both memory (verbal short-term memory, spatial short-term memory, working memory, visuospatial working memory, and episodic memory) and cognition skills (concentration, alertness, reasoning, and mental flexibility) over placebo from baseline to Day 84, with effects on cognitive skills as early as Day 14 and Day 28 for memory. Further, a significant acute effect on concentration was observed as early as 3 hours post single dose consumption of BME. Anxiety score and sleep quality were significantly improved for BME group on Days 28, 56 and 84 as compared to placebo. Serum cortisol levels were significantly reduced from baseline to Day 56 and 84, whereas serum BDNF was significantly increased on Day 84 for BME group as compared to placebo. However, no significant effects were observed for sustained attention and planning tasks. No safety concerns were observed. Conclusion: BME supplementation improved memory and cognitive functions. Anxiety and serum cortisol levels were significantly reduced and sleep quality and serum BDNF was increased by BME consumption. The investigational product was safe and well tolerated throughout the study.