Health TrialsbyHealthPanel

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

ConditionsCognitive Functions Perceptual DisturbancesCognitive Function AbnormalSleepPsychological
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunWay Biotech Co., LTD.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)Capsules

    Dietary supplement

    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.

Treatment groups

50 Participants
are divided into 1 treatment group
Group A: ExoBDNF SWP-CGPA01 (Pediococcus acidilactici)CapsulesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Subjective 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

Secondary outcomes

1

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
2

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
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

SunWay Biotech Co., LTD.

Lead sponsor

Source ClinicalTrials.gov
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