Overview
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?
Description
Researchers will compare dietary phospholipid-rich dairy milk extract to a placebo to evaluate their effectiveness in improving cognitive function in participants.
Participants will:
- Take dietary phospholipid-rich dairy milk extract or a placebo daily for 12 weeks.
- Visit the clinic at 1, 2, 6, and 12 weeks for checkups and tests
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