Ireland
--:--IST
Recruiting Not applicable

Phospholipid-rich Dairy Extract for Cognitive Function

NCT07011680 · tracked via the Priya Life Science South Korea tracker
Phase
Not applicable
Started
2025-01-07
Last updated
2025-06-12

Condition(s) studied

Cognitive FunctionCognitive Decline

Investigational drug(s) / intervention(s)

Phospholipid-rich dairy milk extractPlacebo

Phospholipid-rich dairy milk extract: Dietary phospholipid-rich dairy milk extract 500 mg/day for 12 weeks

Placebo: Placebo (Grape seed oil) 500 mg/day for 12 weeks

Study summary

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?

Eligibility

Sex
ALL
Min age
55 Years
Max age
85 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Change from baseline to 12 weeks in total Computerized NeuroCognitive Function Test score comprising verbal learning test, digit span test, and auditory continuous performance test — 12 weeks
    The change in total CNT score from baseline to 12 weeks, calculated as the sum of verbal learning test, digit span test, and auditory continuous performance test scores. This composite measure assesses overall neurocognitive function across the domains of memory, attention, and sustained concentration. Positive changes indicate cognitive improvement, while negative changes suggest cognitive decline.

Trial sites (1)

FacilityCityRegionStatus
Pusan National University Yangsan Hospital Yangsan South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07011680 on ClinicalTrials.gov ↗ ← All trials in South Korea