Recruiting
Not applicable
Phospholipid-rich Dairy Extract for Cognitive Function
Condition(s) studied
Cognitive FunctionCognitive Decline
Investigational drug(s) / intervention(s)
Phospholipid-rich dairy milk extractPlacebo
Phospholipid-rich dairy milk extract: Dietary phospholipid-rich dairy milk extract 500 mg/day for 12 weeks
Placebo: Placebo (Grape seed oil) 500 mg/day for 12 weeks
Study summary
This clinical trial aims to determine whether dietary phospholipid-rich dairy milk extract improves cognitive function in adults with mild cognitive impairment and to assess its safety.
The main questions are:
* Does dietary phospholipid-rich dairy milk extract improve cognitive function in participants?
* What side effects occur when participants take phospholipid-rich dairy milk extract?
Eligibility
Inclusion Criteria:
* Age: Adults aged 55-85 years (inclusive), both male and female
* Global Deterioration Scale (GDS) score of 2-3:
GDS 2: Subjective memory impairment without objective evidence GDS 3: Mild objective memory impairment
* Absence of dementia according to established diagnostic criteria
* Ability to read Korean
Exclusion Criteria:
* Severe medical conditions within the past 6 months: History of severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage), cardiac disease (angina, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignancy (Note: Participants with a history of cerebrovascular or cardiac disease who are clinically stable may be included at the investigator's discretion)
* Cognitive impairment-associated diseases: Dementia, Parkinson's disease, cerebral infarction, or other conditions associated with cognitive decline Uncontrolled hypertension: Blood pressure ≥160/100 mmHg (measured after 10 minutes of rest)
* Poor glycemic control: Fasting blood glucose ≥160 mg/dL in diabetic patients
* Uncontrolled thyroid dysfunction: Currently receiving treatment for uncontrolled hypothyroidism or hyperthyroidism
* Renal impairment: Serum creatinine ≥2 times the upper limit of normal for the institution
* Hepatic impairment: AST or ALT ≥2 times the upper limit of normal for the institution
* Severe gastrointestinal symptoms: Complaints of severe heartburn, dyspepsia, or other gastrointestinal distress
* Medications affecting cognitive function within the past month: Use of drugs (antipsychotics, anti-degenerative agents, cognitive enhancers, tricyclic antidepressants, hormone replacement therapy) or health functional foods that may influence cognitive function due to dementia or other cognitive abnormalities
* Other clinical trial participation: Participation in other drug clinical trials within the past month or planned participation during the study period
* Alcohol abuse
* Food allergies: Known allergic reactions to study product components
* Investigator discretion: Any other condition deemed inappropriate for study participation by the investigator
Primary outcome measure(s)
- Change from baseline to 12 weeks in total Computerized NeuroCognitive Function Test score comprising verbal learning test, digit span test, and auditory continuous performance test — 12 weeks
The change in total CNT score from baseline to 12 weeks, calculated as the sum of verbal learning test, digit span test, and auditory continuous performance test scores. This composite measure assesses overall neurocognitive function across the domains of memory, attention, and sustained concentration. Positive changes indicate cognitive improvement, while negative changes suggest cognitive decline.
Trial sites (1)
| Facility | City | Region | Status |
| Pusan National University Yangsan Hospital |
Yangsan |
South Korea |
Recruiting |
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