Phospholipid-rich Dairy Extract for Cognitive Function

A 12-week Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Dietary Phospholipid-rich Dairy Milk Extract on Cognitive Function Improvement in Adults With Mild Cognitive Impairment.

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?

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

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