Cognitive FunctionNCT07011680
Phospholipid-rich Dairy Extract for Cognitive Function
A study testing Phospholipid-rich dairy milk extract in people with Cognitive Function and Cognitive Decline, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 55 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Function, Cognitive Decline
- What is being tested?
- Phospholipid-rich dairy milk extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Pusan National University Yangsan Hospital
Yangsan, 50612
Sang Yeoup Lee, MD, PhD, 82-55-360-2860, drsaylee@gmail.com
About this study
Official 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.
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?
Read the 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
- Conditions
- Cognitive Function, Cognitive Decline
- Being tested
- Phospholipid-rich dairy milk extract, Placebo
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phospholipid-rich dairy milk extractDietary supplement
Dietary phospholipid-rich dairy milk extract 500 mg/day for 12 weeks
PlaceboDietary supplement
Placebo (Grape seed oil) 500 mg/day for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Milk group | Experimental | This group takes dietary phospholipid-rich dairy milk extract for 12 weeks. Receives: Dietary Supplement: Phospholipid-rich dairy milk extract |
| Placebo group | Placebo comparator | This group takes placebo for 12 weeks. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start7 Jan 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive FunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pusan National University Yangsan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sang Yeoup Lee, Pusan National University Yangsan Hospital
- Investigators
- Sang Yeoup Lee, Professor, MD, PhD, Principal investigator, Pusan National University Yangsan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07011680
- Sponsor's protocol ID
- 12-2024-013
- Status last verified
- Jun 2025
- First submitted
- 1 Jun 2025
- Last updated
- 12 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07011680
- Acronym / sponsor ID
- 12-2024-013
- Conditions
- Cognitive Function, Cognitive Decline
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Pusan National University Yangsan HospitalUniversity, hospital or other
- Study start
- 7 Jan 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Milk group | Experimental | Dietary Supplement: Phospholipid-rich dairy milk extractThis group takes dietary phospholipid-rich dairy milk extract for 12 weeks. |
| Placebo group | Placebo comparator | Dietary Supplement: PlaceboThis group takes placebo for 12 weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Phospholipid-rich dairy milk extractDietary phospholipid-rich dairy milk extract 500 mg/day for 12 weeks | Dietary supplement | Milk group |
| PlaceboPlacebo (Grape seed oil) 500 mg/day for 12 weeks | Dietary supplement | Placebo group |
Primary outcome
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.
7 secondary outcomes
Change from baseline to 12 weeks in verbal learning test score
Time frame: 12 weeks
Change from baseline to 12 weeks in digit span test score
Time frame: 12 weeks
Change from baseline to 12 weeks in auditory continuous performance test score
Time frame: 12 weeks
Change from baseline to 12 weeks in Korean Mini-Mental State Examination (MMSE-K) total score
Time frame: 12 weeks
Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration
Time frame: 12 weeks
Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration
Time frame: 12 weeks
Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sang Yeoup Lee, Professor, MD, PhD principal investigator
Pusan National University Yangsan Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phospholipid-rich dairy milk extract in people with Cognitive Function and Cognitive Decline, run by Pusan National University Yangsan Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sang Yeoup Lee, Professor, MD, PhD (82+55-360-2860, drsaylee@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.