Clinical trial NCT07011680: Phospholipid-rich Dairy Extract for Cognitive Function
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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Function
Cognitive Decline
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2025-06-10
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline to 12 weeks in verbal learning test score
timeFrame: 12 weeks
measure: Change from baseline to 12 weeks in digit span test score
timeFrame: 12 weeks
measure: Change from baseline to 12 weeks in auditory continuous performance test score
timeFrame: 12 weeks
measure: Change from baseline to 12 weeks in Korean Mini-Mental State Examination (MMSE-K) total score
timeFrame: 12 weeks
measure: Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration
timeFrame: 12 weeks
measure: Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration
timeFrame: 12 weeks
measure: Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Yangsan
country: Korea, Republic of
facility: Pusan National University Yangsan Hospital
Study officials:
affiliation: Pusan National University Yangsan Hospital
name: Sang Yeoup Lee, Professor, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: