NCT07011680 · RECRUITING

Phospholipid-rich Dairy Extract for Cognitive Function

This trial is testing whether a dairy-derived phospholipid supplement improves thinking and memory in adults aged 55 to 85 who have early, mild memory complaints. Researchers are also tracking side effects. It is a Phase NA trial, meaning it is likely a nutrition or wellness study rather than a drug trial, so it follows a different regulatory path than pharmaceutical research. Details on design length and dose are limited in this summary.

Eligibility criteria

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

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2025-06-12

View full record on ClinicalTrials.gov

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