Phospholipid-rich Dairy Extract for Cognitive Function

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• Cognitive Dysfunction 3,843

Cognitive Dysfunction

3,843 studies on the registry are indexed under Cognitive Dysfunction; 1,100 are open to participants now.

This study's planned enrollment of 100 is above the median of 65 across 2,808 interventional studies indexed under Cognitive Dysfunction.

Lead sponsor

Pusan National University Yangsan Hospital is the lead sponsor of 106 studies on the registry; 27 are open to participants now.

Study arms

• Experimental
  Milk group

  This group takes dietary phospholipid-rich dairy milk extract for 12 weeks.

  Dietary Supplement: Phospholipid-rich dairy milk extract

• Placebo comparator
  Placebo group

  This group takes placebo for 12 weeks.

  Dietary Supplement: Placebo

Interventions

• Dietary supplementPhospholipid-rich dairy milk extract

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

• Dietary supplementPlacebo

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

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 weeks

Secondary 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 weeks

2. 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 weeks

3. 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 weeks

4. 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 weeks

5. 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.

   Time frame: 12 weeks

6. 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.

   Time frame: 12 weeks

7. 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.

   Time frame: 12 weeks