Phospholipid-rich dairy extract for mild memory problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.