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NCT Number: NCT07011680

Phospholipid-rich Dairy Extract for Cognitive Function

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?

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Key information

Conditions

Cognitive Function Cognition Disorders Cognitive Decline Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location status: Recruiting

Location contact

Sang Yeoup Lee, MD, PhD

CONTACT

[email protected]

82-55-360-2860

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phospholipid-rich dairy milk extract

Dietary Supplement

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

Placebo

Dietary Supplement

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

    Time frame: 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 outcomes

  1. Change from baseline to 12 weeks in verbal learning test score

    Time frame: 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.

  2. Change from baseline to 12 weeks in digit span test score

    Time frame: 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.

  3. Change from baseline to 12 weeks in auditory continuous performance test score

    Time frame: 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.

  4. Change from baseline to 12 weeks in Korean Mini-Mental State Examination (MMSE-K) total score

    Time frame: 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.

  5. Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration

    Time frame: 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.

  6. Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration

    Time frame: 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.

  7. Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Sang Yeoup Lee, Professor, MD, PhD

CONTACT

[email protected]

82+55-360-2860

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

A 12-week Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety of Dietary Phospholipid-rich Dairy Milk Extract on Cognitive Function Improvement in Adults With Mild Cognitive Impairment.

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 10, 2025
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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