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Nutrients 2019, 11(2), 305; https://doi.org/10.3390/nu11020305

Efficacy and Safety of Lactobacillus Plantarum C29-Fermented Soybean (DW2009) in Individuals with Mild Cognitive Impairment: A 12-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial

1
DONGWHA Pharm Research Institute, 35-71, Topsil-ro, Giheung-gu, Yongin-si 17084, Korea
2
Ewha Brain Institute and Department of Brain & Cognitive Sciences, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Korea
3
Department of Psychiatry, College of Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea
4
Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, 20, Geonjiro Deokjin-gu, Jeonju-si 54907, Korea
5
Department of Life and Nanopharmaceutical Sciences, College of Pharmacy, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea
6
Research Institute of Clinical Medicine of Chonbuk National University-Biomedical Research Institute of Chonbuk National University Hospital, 20, Geonjiro Deokjin-gu, Jeonju-si 54907, Korea
*
Authors to whom correspondence should be addressed.
These authors contributed equally to this work as first authors.
Received: 30 November 2018 / Revised: 25 January 2019 / Accepted: 29 January 2019 / Published: 1 February 2019
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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. View Full-Text
Keywords: Mild cognitive impairment; Lactobacillus plantarum C29-fermented soybean (DW2009); Cognitive impairment; Brain-derived neurotrophic factor Mild cognitive impairment; Lactobacillus plantarum C29-fermented soybean (DW2009); Cognitive impairment; Brain-derived neurotrophic factor
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Hwang, Y.-H.; Park, S.; Paik, J.-W.; Chae, S.-W.; Kim, D.-H.; Jeong, D.-G.; Ha, E.; Kim, M.; Hong, G.; Park, S.-H.; Jung, S.-J.; Lee, S.-M.; Na, K.-H.; Kim, J.; Chung, Y.-C. Efficacy and Safety of Lactobacillus Plantarum C29-Fermented Soybean (DW2009) in Individuals with Mild Cognitive Impairment: A 12-Week, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Clinical Trial. Nutrients 2019, 11, 305.

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