None listed
Conditions
Interventions
Dietary Supplement : Experimental: NVP-2106(1×10^10 CFU/day), 12 weeks, once a day, 2 capsule at a time
Control: Placebo (test object with no NVP-2106 and same properties as test), 12 weeks, once a
Sponsors
NVP Healthcare
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women who are 60 years of age or older at the time of screening and complain of memory decline 2) Those whose CERAD-K word list memory/recall/recognition test score decreased by 1-2 SD from the normal value (those who satisfy at least 1 of the 3 items above) 3) Those with a total score of 22 or less on the Korean version of the Montreal Cognitive Assessment (MOCA-K) 4) A person who, after hearing and fully understanding the detailed explanation of this human application test, voluntarily decides to participate and agrees in writing to comply with the precautions
Exclusion criteria
Exclusion criteria: 1) Those who are currently treated with DSM-IV Axis I Disorders in Structured Clinical Interview for DSM-IV (SCID) conducted at the time of the screening test or have a history of being treated within the last three years. 2) A person who has continuously consumed lactobacillus formulation (or probiotic formulation) and fermented dairy products (yogurt, cheese, etc.) within 2 weeks prior to the screening test (four times or more/week). 3) A person who has alcohol abuse or dependence within three months prior to a screening test. 4) Those with clinically significant acute or chronic cardiovascular system, endocrine system, immune system, respiratory system, hepatometer, kidney and urinary system, neuropsychiatric system, musculoskeletal system, inflammatory and blood and oncogenic, gastrointestinal disease, etc. that require treatment. 5) A person who has taken drugs, health functional foods or herbal medicines related to cognitive and memory improvement within one month prior to a screening test (see prohibited drugs). 6) A person who has taken psychiatric drugs such as antipsychotic drugs, antidepressants, mood control agents, sleeping pills, and anti-anxiety drugs within one month prior to a screening test. 7) Those who have taken antibiotics within four weeks prior to a screening test. 8) A person who has donated whole blood within one month before the screening test or donated ingredients within two weeks. 9) A person who has participated in another human body application test within three months prior to the screening test. 10) Those who show the following results in diagnostic tests and medical tests. ? AST, ALT > 3 times the upper limit of the reference range ? Serum Creatinine > 2.0 mg/dL 11) A person who determines that the examiner is unfit to participate in the study due to other reasons, including the results of diagnostic tests and medical tests.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive 13(ADAS-Cog13) total score;CNT (Visual learning test,Visual learning test), Auditory Continuous Performance Task;Trail Making Test | — |
Secondary
| Measure | Time frame |
|---|---|
| serum Brain-derived neurotrophic factor(BDNF);serum Amyloid-ß;IL-1ß, IL-6, IL-10, TNF-a;The Montreal Cognitive Assessment Korean version(MOCA-K);Alzheimer's Disease Assessment Scale-Cognitive 13(ADAS- Cog13) sub score;Next generation sequencing(NGS) | — |
Countries
Korea, Republic of
Contacts
Public ContactJung Eun-Soo
Jeonbuk National University Hospital
Outcome results
None listed