Phospholipid-rich dairy extract for mild memory problems
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 will test whether taking a daily phospholipid-rich dairy milk extract for 12 weeks helps adults aged 55–85 with mild cognitive impairment think and remember better and whether it is safe.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 55 Years to 85 Years |
| Sex | All |
| Sponsor | Pusan National University Yangsan Hospital Academic / other |
| Locations | 1 site (Yangsan) |
| Trial ID | NCT07011680 on ClinicalTrials.gov |
What this trial studies
This is a randomized, placebo-controlled intervention comparing a daily phospholipid-rich dairy milk extract to a matching placebo over 12 weeks in adults with mild cognitive impairment. Participants visit the clinic at weeks 1, 2, 6, and 12 for cognitive testing, safety checks, and monitoring for side effects. Eligible participants are 55–85 years old with Global Deterioration Scale scores of 2–3 and no dementia, and they must be able to read Korean. Major recent medical events, uncontrolled hypertension, and other neurologic diseases associated with cognitive decline are excluded or may disqualify participants.
Who should consider this trial
Good fit: Adults aged 55–85 with mild cognitive impairment (GDS 2–3), no diagnosis of dementia, able to read Korean, and medically stable would be ideal candidates.
Not a fit: People with diagnosed dementia, Parkinson's disease, recent severe cerebrovascular or cardiac events, uncontrolled hypertension, or who cannot travel to or read Korean at the study site are unlikely to benefit from participation.
Why it matters
Potential benefit: If effective, this could offer a simple, well-tolerated dietary supplement option to improve or stabilize thinking and memory in people with early cognitive decline.
How similar studies have performed: Some prior trials of phospholipid compounds (for example phosphatidylserine) have shown modest cognitive benefits in older adults, but results are mixed and dairy-derived phospholipid extracts are less well studied.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Yangsan
- Pusan National University Yangsan Hospital — Yangsan, South Korea (Recruiting)
Study contacts
- Principal investigator: Sang Yeoup Lee, Professor, MD, PhD — Pusan National University Yangsan Hospital
- Study coordinator: Sang Yeoup Lee, Professor, MD, PhD
- Email: drsaylee@gmail.com
- Phone: 82+55-360-2860
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.