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

Yun-Ha Hwang, Shinwon Park, Jong-Woo Paik, Soo-Wan Chae, Dong-Hyun Kim, Doc-Gyun Jeong, Eunji Ha, Myeongju Kim, Gahae Hong, Soo-Hyun Park, Su-Jin Jung, Sang-Min Lee, Kyu-Heum Na, Jungyoon Kim, Young-Chul Chung

Journal: Nutrients 2019;11(2):305

PMID: 30717153

Plain Language Summary

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Mild cognitive impairment (MCI) describes a range of symptoms that impact on cognition and memory, but not to such an extent that it seriously affects a person's day to day life. People with MCI are at higher risk of going on to develop dementia. Consumption of both probiotics and soy beans have been shown to enhance memory function in previous studies on animals and humans. In this Korean study, a randomised, double-blind, placebo-controlled trial, researchers used soybeans that had been fermented with a bacterium called Lactobacillus plantarum C29, a type of bacteria which is found in the traditional Korean food kimchi. One hundred men and women diagnosed with MCI were given capsules containing either 800 mg of dried fermented soybeans or a placebo for 12 weeks. Participants underwent a series of memory and attention tests to measure cognitive function. Researchers also looked at levels of a protein that supports nerve cells, called brain-derived neurotropic factor (BDNF) in the blood, as well as the composition of bacteria in the stool samples of the participants. The group that consumed the fermented soybeans showed greater improvements in the overall cognitive function, especially attention, compared to those who took the placebo. BDNF levels increased in the soybean group but declined in the placebo group. Increases in BDNF were associated with improvements in cognitive function. The results of this clinical trial suggest that fermented soybeans can be safely consumed by people with MCI to enhance cognitive function. The authors suggested that the increase in blood BDNF levels may be partly responsible for the improved cognitive function, and this in turn points to the importance of the so-called gut-brain axis in improving symptoms of MCI.

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 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, = 50) or placebo (800 mg/day, = 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 ( = 2.36, for interaction = 0.02), especially in the attention domain ( = 2.34, for interaction = 0.02). Cognitive improvement was associated with increased serum BDNF levels after consumption of DW2009 ( = 2.83, = 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.

Address: DONGWHA Pharm Research Institute, 35-71, Topsil-ro, Giheung-gu, Yongin-si 17084, Korea. [email protected].; Ewha Brain Institute and Department of Brain & Cognitive Sciences, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Korea. [email protected].; Department of Psychiatry, College of Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea. [email protected].; Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, 20, Geonjiro Deokjin-gu, Jeonju-si 54907, Korea. [email protected].; Department of Life and Nanopharmaceutical Sciences, College of Pharmacy, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea. [email protected].; DONGWHA Pharm Research Institute, 35-71, Topsil-ro, Giheung-gu, Yongin-si 17084, Korea. [email protected].; Ewha Brain Institute and Department of Brain & Cognitive Sciences, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Korea. [email protected].; Ewha Brain Institute and Department of Brain & Cognitive Sciences, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Korea. [email protected].; Ewha Brain Institute and Department of Brain & Cognitive Sciences, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Korea. [email protected].; Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, 20, Geonjiro Deokjin-gu, Jeonju-si 54907, Korea. [email protected].; Clinical Trial Center for Functional Foods, Chonbuk National University Hospital, 20, Geonjiro Deokjin-gu, Jeonju-si 54907, Korea. [email protected].; Department of Psychiatry, College of Medicine, Kyung Hee University, 26, Kyungheedae-ro, Dongdaemun-gu, Seoul 02447, Korea. [email protected].; DONGWHA Pharm Research Institute, 35-71, Topsil-ro, Giheung-gu, Yongin-si 17084, Korea. [email protected].; Ewha Brain Institute and Department of Brain & Cognitive Sciences, Ewha Womans University, 52, Ewhayeodae-gil, Seodaemun-gu, Seoul 03760, Korea. [email protected].; 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. [email protected].
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