Phospholipid-rich Dairy Extract for Cognitive Function
- Conditions
- Cognitive FunctionCognitive Decline
- Registration Number
- NCT07011680
- Lead Sponsor
- Pusan National University Yangsan Hospital
- Brief 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?
- Detailed Description
Researchers will compare dietary phospholipid-rich dairy milk extract to a placebo to evaluate their effectiveness in improving cognitive function in participants.
Participants will:
* Take dietary phospholipid-rich dairy milk extract or a placebo daily for 12 weeks.
* Visit the clinic at 1, 2, 6, and 12 weeks for checkups and tests
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration 12 weeks The change in serum BDNF concentration from baseline to 12 weeks, measured in ng/mL or pg/mL. BDNF is a neurotrophin that plays a crucial role in neuronal survival, growth, and synaptic plasticity. Positive changes indicate increased BDNF levels associated with enhanced neuroplasticity and neuroprotection, while negative changes suggest decreased neurotrophic support.
Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration 12 weeks The change in serum MDA concentration from baseline to 12 weeks, measured in μmol/L or nmol/mL. MDA is a biomarker of lipid peroxidation and oxidative stress, reflecting cellular damage from reactive oxygen species. Positive changes indicate increased oxidative stress and cellular damage, while negative changes suggest reduced oxidative stress and improved antioxidant status.
Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity 12 weeks The change in serum SOD activity from baseline to 12 weeks, measured in U/mL or U/mg protein. SOD is a key antioxidant enzyme that catalyzes the dismutation of superoxide radicals, providing cellular protection against oxidative damage. Positive changes indicate enhanced antioxidant capacity and cellular protection, while negative changes suggest reduced antioxidant defense mechanisms.
Change from baseline to 12 weeks in auditory continuous performance test score 12 weeks 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.
Change from baseline to 12 weeks in verbal learning test score 12 weeks 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.
Change from baseline to 12 weeks in digit span test score 12 weeks 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.
Change from baseline to 12 weeks in Korean Mini-Mental State Examination (MMSE-K) total score 12 weeks 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.
Trial Locations
- Locations (1)
Pusan National University Yangsan Hospital
🇰🇷Yangsan, Korea, Republic of