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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:
Researchers will compare dietary phospholipid-rich dairy milk extract to a placebo to evaluate their effectiveness in improving cognitive function in participants.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Milk group | Experimental | This group takes dietary phospholipid-rich dairy milk extract for 12 weeks. |
|
| Placebo group | Placebo Comparator | This group takes placebo for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Phospholipid-rich dairy milk extract | Dietary Supplement | Dietary phospholipid-rich dairy milk extract 500 mg/day for 12 weeks |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
GDS 2: Subjective memory impairment without objective evidence GDS 3: Mild objective memory impairment
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sang Yeoup Lee, Professor, MD, PhD | Contact | 82+55-360-2860 | drsaylee@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sang Yeoup Lee, Professor, MD, PhD | Pusan National University Yangsan Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pusan National University Yangsan Hospital | Recruiting | Yangsan | 50612 | South Korea |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| Placebo | Dietary Supplement | Placebo (Grape seed oil) 500 mg/day for 12 weeks |
|
| 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| 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. | 12 weeks |
| Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration | 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. | 12 weeks |
| Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration | 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. | 12 weeks |
| Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity | 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. | 12 weeks |