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

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.

Interplay Between Human Gut Bacteria Escherichia coli and Lactobacillus mucosae in the Occurrence of Neuropsychiatric Disorders in Mice

“…Bifidobacterium breve strain A1 prevents cognitive impairment in Alzheimer's disease (40). L. plantarum C29 improved cognitive function in mice and patient with mild cognitive decline by regulating NF-κB activation and inducing BDNF expression (22,41). L. plantarum 299v improves cognitive functions in patients with major depression by decreasing kynurenine concentration (42).…”

Can probiotics, prebiotics and synbiotics improve functional outcomes for older people: a systematic review

“…Hwang et al (GRADE certainty = ‘low’) conducted an RCT looking at the effects of a probiotic on cognition in participants ( n = 100) with mild cognitive impairment (MCI) [ 25 ]. The authors used a battery of neuro-cognitive tests to assess cognition at baseline and after 12 weeks of either placebo or a probiotic.…”

“…Adverse events reported by Hwang et al included dizziness, stomach aches, headaches, gastritis, erectile dysfunction and seborrheic dermatitis in the intervention group receiving probiotic capsules daily for 12 weeks [14% of participants (7/50) in the intervention group reported an adverse event]. Irregular bowel movements, stomach aches and erectile dysfunction were the adverse events reported in the placebo group [10% of participants in the placebo group (5/50) reported an adverse event] [ 25 ]. More patients dropped out of the placebo group than the probiotic intervention group in Östlund-Lagerström et al’s study (20 vs. 11) with no serious adverse events in either group [ 19 ].…”

“…Three studies in this review identified an improvement in MMSE in older people who had been taking a probiotic [ 24 , 26 , 28 ] and a fourth study reported improved combined cognitive function after probiotics using a neuro-cognitive battery test [ 25 ]. All of these studies involved participants with pre-existing cognitive impairment.…”

Lactobacillus Rhamnosus GG Affects the BDNF System in Brain Samples of Wistar Rats with Pepsin-Trypsin-Digested Gliadin (PTG)-Induced Enteropathy

“…The effectiveness of probiotic supplementation in the reduction of psychological symptoms [42,43] and as an alternative treatment for CD [25] are nowadays the objects of investigation. Indeed, recent results from clinical trials [44], animal models [45], and in vitro studies [46] indicate that the Lactobacillus administration up-regulates BDNF expression.…”