Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological

Official title

Effect of ExoBDNF Lactic Acid Bacteria Supplement on Cognitive Functions, Sleep and Psychological Outcomes: An Open-label Trial

Overview

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.

Interventions

• Dietary supplement ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules
  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.

Primary outcome measures

• Subjective Cognitive Decline Questionnaire (SCD-Q) scale [Time frame: 8 weeks]

Secondary outcome measures (5)

• Computerized cognitive test-Go/No go [Time frame: 8 weeks]
• Computerized cognitive test-Task-switching [Time frame: 8 weeks]
• Computerized cognitive test-Working memory [Time frame: 8 weeks]
• Depression Anxiety Stress Scale DASS-21 [Time frame: 8 weeks]
• Pittsburgh Sleep Quality Index (PSQI) [Time frame: 8 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Taiwan · 1 center

• Tri-Service General Hospital, National Defense Medical Center — Taipei

Publications

• Klimova B, Valis M, Kuca K. Cognitive decline in normal aging and its prevention: a review on non-pharmacological lifestyle strategies. Clin Interv Aging. 2017 May 25;12:903-910. doi: 10.2147/CIA.S132963. eCollection 2017. PMID 28579767
• Erickson KI, Donofry SD, Sewell KR, Brown BM, Stillman CM. Cognitive Aging and the Promise of Physical Activity. Annu Rev Clin Psychol. 2022 May 9;18:417-442. doi: 10.1146/annurev-clinpsy-072720-014213. Epub 2022 Jan 19. PMID 35044793
• O'Donoghue MC, Murphy SE, Zamboni G, Nobre AC, Mackay CE. APOE genotype and cognition in healthy individuals at risk of Alzheimer's disease: A review. Cortex. 2018 Jul;104:103-123. doi: 10.1016/j.cortex.2018.03.025. Epub 2018 Mar 30. PMID 29800787
• Shakersain B, Santoni G, Larsson SC, Faxen-Irving G, Fastbom J, Fratiglioni L, Xu W. Prudent diet may attenuate the adverse effects of Western diet on cognitive decline. Alzheimers Dement. 2016 Feb;12(2):100-109. doi: 10.1016/j.jalz.2015.08.002. Epub 2015 Sep 3. PMID 26342761
• Schneider S, Wright CM, Heuckeroth RO. Unexpected Roles for the Second Brain: Enteric Nervous System as Master Regulator of Bowel Function. Annu Rev Physiol. 2019 Feb 10;81:235-259. doi: 10.1146/annurev-physiol-021317-121515. Epub 2018 Oct 31. PMID 30379617
• Kowalski K, Mulak A. Brain-Gut-Microbiota Axis in Alzheimer's Disease. J Neurogastroenterol Motil. 2019 Jan 31;25(1):48-60. doi: 10.5056/jnm18087. PMID 30646475
• D'Amato A, Di Cesare Mannelli L, Lucarini E, Man AL, Le Gall G, Branca JJV, Ghelardini C, Amedei A, Bertelli E, Regoli M, Pacini A, Luciani G, Gallina P, Altera A, Narbad A, Gulisano M, Hoyles L, Vauzour D, Nicoletti C. Faecal microbiota transplant from aged donor mice affects spatial learning and memory via modulating hippocampal synaptic plasticity- and neurotransmission-related proteins in youn PMID 33004079
• Dominguez LJ, Barbagallo M. Nutritional prevention of cognitive decline and dementia. Acta Biomed. 2018 Jun 7;89(2):276-290. doi: 10.23750/abm.v89i2.7401. PMID 29957766

Identifiers

NCT: NCT06968299 · 25-ExoBDNF-1

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗