None listed
Conditions
Interventions
Dietary Supplement : Participants will consume the assigned investigational product (IP) once daily, 500 mg per capsule, for 12 weeks according to the randomly assigned group.
Intervention group: Re
Sponsors
AceBiome Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult male or female, aged 60 or older and under 75 years. 2) Able to read and write Korean. 3) A decrease of 1.0 SD or more and 2.0 SD or less in one or more of the CERAD-K word list memory/recall/recognition tests compared to peers of the same education level and age. 4) Agree to participate in this human clinical trial and complete a written informed consent form before the start of the clinical trial.
Exclusion criteria
Exclusion criteria: 1) Those with the following medical history or a history of procedures/surgeries: ? Those currently being treated for severe immune, respiratory, gastrointestinal/liver and biliary, renal and urinary, nervous, endocrine, infectious, or malignant diseases. ? Those with diseases that may affect cognitive abilities (dementia, Parkinson's disease, systemic vascular disease, etc.) or cognitive impairment due to brain or mental illness. ? Those with severe hearing or vision impairment. ? Those with a history of mental illness (depression, schizophrenia, bipolar disorder, ADHD, etc.). ? Those with a history of alcohol or drug abuse/dependence/addiction. ? Those with a history of infections that affect brain function (HIV, syphilis, etc.) or a history of vitamin B12 or folate deficiency. ? Those with severe head trauma accompanied by loss of consciousness, cardiovascular disease (angina pectoris, myocardial infarction, transient ischemic attack, stroke, cerebral infarction) within 6 months (180 days) of Visit 1. (e.g., epilepsy), or those with a history of procedures/surgical procedures due to related diseases (cerebral aneurysm embolization, craniotomy, coronary artery bypass grafting, coronary artery intervention, etc.) {However, acute stroke is excluded only if the history is within 3 months (90 days) of Visit 1} 2) Those who have used the following drugs or foods within 1 month (30 days) of Visit 1: ? Dementia medications (Donepezil, Galantamine, Rivastigmine, etc.) ? Brain function improvement medications (Citicoline, Oxiracetam, Ginkgo-Biloba, Nimodipine, etc.) ? Drugs that may affect cognitive function (central nervous system stimulants, antipsychotics, anticholinergics, antidepressants, benzodiazepines, anticancer drugs, systemic steroids, thyroid hormones, first-generation antihistamines, etc.) ? Vitamin B12, health functional foods related to improving cognitive function and memory 3) Systemic antibiotics, systemic antidepressants, etc. within 2 weeks of Visit 1 Those using antibiotics or intestinal preparations 4) Those who have taken probiotics, prebiotics, or lactic acid bacteria products consistently (more than 4 days a week) within 2 weeks of Visit 1 5) Heavy smokers (more than 20 cigarettes per day) 6) Chronic alcohol users* *Consuming alcohol equivalent to an average of 40 g or more per day (280 g/week) for men and 20 g or more per day (140 g/week) for women 7) Those whose AST (GOT) or ALT (GPT) levels are three times or more the upper limit of normal for the testing institution 8) Those with an Hb level of 8 g/dL or less or a PLT level of less than 100,000/mm3 9) Those with a TSH level of less than 0.1 mlU/L or 10 mlU/L or more 10) Those with an eGFR of less than 60 mL/min/1.73 m2 or those with acute or chronic renal failure requiring dialysis 11) Uncontrolled hypertension Patients (systolic blood pressure exceeding 140 mmHg or diastolic blood pressure exceeding 90 mmHg, based on measurements taken after the subject rested for 10 minutes) 12) Patients with uncontrolled diabetes (fasting blood sugar 126 mg/dL or higher) 13) Pregnant or lactating women or those planning to become pregnant during this human clinical trial 14) Those who have participated in another interventional clinical trial (including human clinical trials) within 3 months (90 days) of Visit 1 or plan to participate in another interventional clinical trial (including human clinical trials) during this human clinical trial 15) Those who are sensitive or allergi
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ADAS-cog(Alzheimer's Disease Assessment Scale – Cognitive Subscale) 13 total score | — |
Secondary
| Measure | Time frame |
|---|---|
| ADAS-cog(Alzheimer's Disease Assessment Scale – Cognitive Subscale) memory score;ADAS-cog(Alzheimer's Disease Assessment Scale – Cognitive Subscale) 13 subscale score;K-MoCA(Korean version of the Montreal Cognitive Assessment);Visual C.P.T.(Continuous Performance Test);IL(Interleukin)-1ß ;BDNF(Brain-Derived Neurotrophic Factor), Tau-protein, Amyloid-ß(1-42, 1-40) ;Antioxidant-related indicators | — |
Countries
Korea, Republic of
Contacts
Public ContactJong Woo Paik
Kyung Hee University Hospital
Outcome results
None listed