Phospholipid-rich Dairy Extract for Cognitive Function
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age55-85
SponsorPusan National University Yangsan Hospital
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
Age: Adults aged 55-85 years (inclusive), both male and female
Absence of dementia according to established diagnostic criteria
Ability to read Korean
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Phospholipid-rich dairy milk extract
Dietary supplementDietary phospholipid-rich dairy milk extract 500 mg/day for 12 weeks
Placebo
Dietary supplementPlacebo (Grape seed oil) 500 mg/day for 12 weeks
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Milk groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
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.
Time frame
12 weeksSecondary outcomes
1
Change from baseline to 12 weeks in verbal learning test score
The change in verbal learning test score from baseline to 12 weeks, measuring memory and learning capacity. This assessment evaluates the ability to acquire, retain, and recall verbal information over multiple learning trials. Positive changes indicate improvement in verbal memory function, while negative changes suggest a decline in verbal learning capacity.
Time frame
12 weeks2
Change from baseline to 12 weeks in digit span test score
The change in digit span test score from baseline to 12 weeks, measuring working memory and attention span. This assessment evaluates the ability to temporarily hold and manipulate numerical information in memory through forward and backward digit recall tasks. Positive changes indicate improvement in working memory capacity, while negative changes suggest decline in attention and short-term memory function.
Time frame
12 weeks3
Change from baseline to 12 weeks in auditory continuous performance test score
The change in auditory continuous performance test score from baseline to 12 weeks, measuring sustained attention and concentration abilities. This assessment evaluates the capacity to maintain focused attention and respond appropriately to auditory stimuli over an extended period. Positive changes indicate improvement in sustained attention function, while negative changes suggest decline in concentration and vigilance capabilities.
Time frame
12 weeks4
Change from baseline to 12 weeks in Korean Mini-Mental State Examination (MMSE-K) total score
The change in MMSE-K total score from baseline to 12 weeks, providing a brief assessment of global cognitive function. This standardized instrument evaluates orientation, attention, memory, language, and visuospatial abilities. Positive changes indicate improvement in overall cognitive status, while negative changes suggest decline in general cognitive function.
Time frame
12 weeksSponsors and contacts
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Source ClinicalTrials.gov