This open-label, single-group, pre/post-test clinical study was conducted to investigate whether ExoBDNF probiotic supplementation could improve cognitive ability. It is expected that 40 subjects aged 18 years and above will be recruited, with a target of 30 cases, to take ExoBDNF probiotics for a total of 8 weeks.
Pre-test and post-test were conducted at week 0 and week 9, respectively. The test items included Cognitive Test Battery, SCD-Q Subjective Cognitive Decline Questionnaire, TCQ Cognitive Function Scale, MMSE Mini-Mental Scale, MoCA Montreal Cognitive Assessment Scale, PSQI Pittsburgh Sleep Quality Scale and DASS-21 Depression, Anxiety and Stress Scale, as well as blood biochemical examination and fecal intestinal flora analysis. The subjects were asked to take a capsule containing 1 x 1010 CFU of ExoBDNF probiotics once daily. Subjects are required to maintain a regular lifestyle. After starting the diet, subjects filled out a daily diary that included questions about study product intake, other food intake, bowel movement frequency, stool quality (consistency and color), any medications received, and any unpleasant symptoms such as diarrhea, constipation, vomiting, flatulence, and discomfort. It is expected that this project will help clarify whether supplementation with Pediococcus acidilactici ExoBDNF can help improve cognitive ability, sleep or mental health.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Product ingredients: microcrystalline cellulose, corn starch, SWP-CGPA01 Pediococcus acidilactici powder (1.0 x 10\^10 CFU); Capsule shell composition: HPMC (hydroxypropyl methylcellulose), pure water, titanium dioxide, gelatin.
Tri-Service General Hospital, National Defense Medical Center
Taipei, Taiwan
RECRUITINGSubjective Cognitive Decline Questionnaire (SCD-Q) scale
To compare whether there is a statistically significant difference in the Subjective Cognitive Decline Questionnaire (SCD-Q) scale scores between the trial group and the placebo group after taking the probiotics for 8 weeks compared with the values 8 weeks ago (baseline).
Time frame: 8 weeks
Computerized cognitive test-Go/No go
Mainly used to assess concentration, reaction and memory, this task is used to measure the brain's ability to distinguish relevant and irrelevant information. The task requires participants to pay attention to the prompt and judge whether the subsequent stimulus is the target.
Time frame: 8 weeks
Computerized cognitive test-Task-switching
Mainly used to assess the brain's task switching ability, the task switching task is used to measure the flexibility of selective attention. The task requires participants to switch their attention between judging the cardinality of even numbers or the size of numbers.
Time frame: 8 weeks
Computerized cognitive test-Working memory
Mainly used to assess memory, this working memory task refers to the spatial span task (Corsi block tapping task), which is used to measure spatial short-term memory capacity.
Time frame: 8 weeks
Depression Anxiety Stress Scale DASS-21
The Depression, Anxiety and Stress Scale - 21 Items (DASS-21) is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress.
Time frame: 8 weeks
Pittsburgh Sleep Quality Index (PSQI)
The Pittsburgh Sleep Quality Index (PSQI) is a self-assessment questionnaire that assesses sleep quality and sleep disturbances over a one-month period.
Time frame: 8 weeks
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