None listed
Conditions
Interventions
Dietary Supplement : This clinical trial evaluates the cognitive-enhancing effects and safety of whey protein hydrolysate (WPH) by comparing an active test-food group with a placebo control group unde
the remaining weight consists of excipients (e.g., carbohydrate base, flavors) formulated to match the placebo.
Duration: 12 weeks of continuous administration
Route and method of administration: Or
only the excipient matrix is included.
Duration: 12 weeks
Route and method of administration: Identical oral regimen
one sachet dissolved in about 100 mL of water, taken once daily.
Formulation and appearance: The placebo is matched to the test product in appearance, taste, smell, packaging, and labeling (except fo
Sponsors
Neo Cremar
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Men and women aged =55 years and =85 years who complain of cognitive decline 2. Individuals who are able to read and understand Korean 3. Individuals whose CERAD-K memory score (Word List Memory Test, Word List Recall Test, or Word List Recognition Test) is decreased by =1.0 SD compared with the mean value for the same age and education level 4. Individuals who agree to participate in this clinical trial before the start of the study and who voluntarily sign the written informed consent form
Exclusion criteria
Exclusion criteria: 1. Individuals with allergy to milk or dairy products, or with a history of hypersensitivity reactions to drugs, food ingredients, herbal extracts, herbal medicines, or dietary supplements 2. Individuals who have received medications for dementia or other cognitive impairment (anti-dementia drugs, cerebral metabolic enhancers, thyroid hormone preparations, central nervous system stimulants, antipsychotics, anticholinergics, tricyclic antidepressants, or drugs for degenerative diseases) within 4 weeks prior to the screening visit 3. Individuals who have received estrogen replacement therapy (except for topical preparations) within 2 months prior to the screening visit 4. Individuals who have taken health functional foods (health supplements) related to cognitive function improvement within 2 weeks prior to the start of the clinical trial 5. Individuals who are currently hospitalized for, or have been discharged within the past 3 months after treatment of, malignant tumors, severe cerebrovascular disease (e.g., cerebral infarction, cerebral hemorrhage), or severe heart disease (e.g., unstable angina, myocardial infarction, arrhythmias requiring treatment for heart failure) 6. Individuals with serious psychiatric disorders such as schizophrenia, severe depression, psychotic disorders, alcohol dependence, or drug dependence 7. Individuals diagnosed with diseases accompanied by cognitive impairment such as dementia, Parkinson’s disease, or cerebral infarction, based on DSM-5 diagnostic criteria 8. Individuals who are receiving vitamin E preparations at a daily dose of =400 IU, or whose vitamin E dose is expected to require adjustment (dose reduction) during the study 9. Individuals with an estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73 m² 10. Individuals whose AST or ALT levels are =3 times the upper limit of normal at the study site 11. Individuals with thyroid disease with TSH = 0.1 µIU/mL or = 10 µIU/mL 12. Individuals with uncontrolled hypertension (blood pressure = 160/100 mmHg) 13. Individuals with uncontrolled diabetes mellitus (fasting plasma glucose = 180 mg/dL) 14. Women who are pregnant or breastfeeding, or who plan to become pregnant within 3 months 15. Individuals who have participated in another human clinical trial within 3 months prior to the start of this clinical trial, or who plan to participate in another human clinical trial after enrollment in this study 16. Individuals who are judged by the principal investigator to be inappropriate for participation in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in ADAS-Cog total score after Visit 4 (12 weeks) compared to Visit 2 (0 weeks) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total score of the Montreal Cognitive Assessment-Korea (MoCA-K) from visit 2 (week 0) to visit 4 (week 12);Change in the total score of the Mini-Mental State Examination (MMSE) from visit 2 (week 0) to visit 4 (week 12);Changes in the Verbal Learning Test, Auditory CPT, Digit Span Test, and Visual CPT scores of the CNT (Computerized Neurocognitive Testing) after Visit 4 (12 weeks) compared to Visit 2 (0 weeks);Change in BDNF (Brain Derived Neurotrophic Factor) levels after visit 4 (week 12) compared to visit 2 (week 0) | — |
Countries
Korea, Republic of
Contacts
Public ContactSeon Mi Shin
Semyung University Oriental Medicine Hospital
Outcome results
None listed