Abstract

Early intervention using dietary supplements may be effective in alleviating cognitive impairment among individuals with mild cognitive impairment (MCI). This study investigated the efficacy and safety of Lactobacillus plantarum C29-fermented soybean (DW2009) as a nutritional supplement for cognitive enhancement. One hundred individuals with MCI were randomly assigned to take DW2009 (800 mg/day, n = 50) or placebo (800 mg/day, n = 50) for 12 weeks. The primary outcome measure was change in the composite score of cognitive functions related to memory and attention, measured by computerized neurocognitive function tests. Associations between changes in serum brain-derived neurotrophic factor (BDNF) levels and cognitive performance for each treatment group were evaluated. Compared to the placebo group, the DW2009 group showed greater improvements in the combined cognitive functions (z = 2.36, p for interaction = 0.02), especially in the attention domain (z = 2.34, p for interaction = 0.02). Cognitive improvement was associated with increased serum BDNF levels after consumption of DW2009 (t = 2.83, p = 0.007). The results of this clinical trial suggest that DW2009 can be safely administered to enhance cognitive function in individuals with MCI. Increased serum BDNF levels after administering DW2009 may provide preliminary insight into the underlying effects of cognitive improvement, which suggests the importance of the gut-brain axis in ameliorating cognitive deficits in MCI.

Highlights

  • Mild cognitive impairment (MCI) refers to a state of cognitive deterioration that precedes the clinical diagnosis of Alzheimer’s disease (AD) and other dementias, which does not yet compromise daily functioning [1]

  • WBC, white blood cell; RBC, red blood cell; AST, aspartate aminotransferase; ALT, alanine aminotransferase; ALP, alkaline phosphatase; BUN, blood urea nitrogen. This double-blind, placebo-controlled randomized clinical trial (RCT) examined the effects of DW2009 as a dietary supplement for individuals with mild cognitive impairment (MCI)

  • To the best of our knowledge, this is the first study to investigate the cognitive enhancement effects of DW2009 in humans and our findings extend the previously reported evidence of cognitive improvement from animal studies

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Summary

Introduction

Mild cognitive impairment (MCI) refers to a state of cognitive deterioration that precedes the clinical diagnosis of Alzheimer’s disease (AD) and other dementias, which does not yet compromise daily functioning [1]. We confirmed the positive effects of DW2009 on cognition in a preclinical study, where oral administration of DW2009 normalized the disturbed gut microbiota composition and increased hippocampal BDNF levels in AD mouse models [13]. Both Lactobacillus plantarum C29 and DW2009 increased cognitive function, DW2009 more effectively suppressed the accumulation of amyloid-β plaques and alleviated memory impairment in AD mice [13]. Serum BDNF levels were evaluated in association with change in cognitive function

Participants
Procedure
Measurement of Cognitive Functions
Safety Measures
Measurement of Serum BDNF levels
Fecal Microbiota Analysis
Statistical Analysis
Participant Characteristics
Adherence to Treatment
Primary Outcome Measure
Associations between Changes in Serum BDNF Levels and Cognitive Performance
Association
Change in Gut Microbiota Composition
Safety and Tolerability
Discussion

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