Phospholipid-rich Dairy Extract for Cognitive Function

Launched by PUSAN NATIONAL UNIVERSITY YANGSAN HOSPITAL · Jun 1, 2025

Keywords

ClinConnect Summary

This clinical trial is studying whether a special dairy milk extract, rich in phospholipids (a type of fat that helps with brain health), can help improve thinking and memory in adults who have mild cognitive impairment. Mild cognitive impairment means that a person may notice some memory problems but does not have dementia. The researchers are also looking at the safety of this dairy extract to see if it causes any side effects.

To participate in this study, you need to be an adult between 55 and 85 years old, and have some level of memory issues, but not severe enough to be diagnosed with dementia. You should also be able to read Korean. If you have certain serious health conditions, like severe heart or brain issues, uncontrolled high blood pressure or diabetes, or if you are taking specific medications that affect your thinking, you may not be eligible. Participants in the trial will take the dairy extract and will be monitored for any changes in their cognitive function and any side effects. This trial is currently recruiting participants, and it could be a valuable opportunity for those looking to improve their cognitive health.

Gender

ALL

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