Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological Outcomes: An Open-label Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- SunWay Biotech Co., LTD.
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Subjective Cognitive Decline Questionnaire (SCD-Q) scale
Study Overview
Brief Summary
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.
Detailed Description
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Subjects must be volunteers who are 18 years of age or older, mentally clear and able to communicate.
- •Subjects who agree to participate in this trial and voluntarily sign the trial consent form.
Exclusion Criteria
- •Subjects who are expected to be or have been confirmed to be pregnant (medical history).
- •Subjects with gallbladder disease, gastrointestinal disease, gout, porphyria, or a history of gastric weight control surgery.
- •Subjects with high blood pressure (≥160/100 mmHg after resting for 10 minutes) or taking diuretics.
- •Subjects with heart disease, hepatorenal insufficiency, hyperthyroidism or hypothyroidism, Cushing's syndrome, malignant tumors, or any other disease that may affect the results of the study.
- •Subjects with severe hearing or visual impairment that makes it impossible to perform examinations and assessments.
- •Subjects with any history of brain surgery, penetrating, neurovascular, infectious or other severe brain injury, epilepsy or other major neurological abnormalities, such as traumatic brain injury with loss of consciousness for more than 24 hours, or memory loss after head trauma for more than 7 days were excluded.
- •Subjects with intellectual disabilities.
- •Subjects who had consumed probiotics or were expected to consume probiotics within 2 weeks before the screening visit.
- •Subjects who had participated in or were expected to participate in clinical trials within 4 weeks before the screening visit.
Arms & Interventions
ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules
ExoBDNF is the product name of SWP-CGPA01 Pediococcus acidilactici, which is listed as a food-usable strain in Taiwan, China, Europe and the United States. The strain has been deposited in the National Collection of Industrial Food and Marine Bacteria (NCIMB) in the United Kingdom, and the strain number is NCIMB 44102. 1.0 x 1010 CFU SWP-CGPA01 freeze-dried powder (production and development: Morning Blossom Biotechnology Co., Ltd., Taipei, Taiwan), corn starch, crystalline cellulose and excipients in plant capsules.
Intervention: ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules (Dietary Supplement)
Outcomes
Primary Outcomes
Subjective Cognitive Decline Questionnaire (SCD-Q) scale
Time Frame: 8 weeks
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).
Secondary Outcomes
- Computerized cognitive test-Go/No go(8 weeks)
- Computerized cognitive test-Task-switching(8 weeks)
- Computerized cognitive test-Working memory(8 weeks)
- Depression Anxiety Stress Scale DASS-21(8 weeks)
- Pittsburgh Sleep Quality Index (PSQI)(8 weeks)