Phospholipid-rich Dairy Extract for Cognitive Function

Pusan National University Yangsan Hospital

Status: Enrolling

Conditions: Cognitive Function; Cognitive Decline

Treatments: Dietary Supplement: Phospholipid-rich dairy milk extract; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07011680

12-2024-013

Details and patient eligibility

About

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?

Full 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

Enrollment: 100 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups, including a placebo group

Milk group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Phospholipid-rich dairy milk extract

Placebo group

Placebo Comparator group

Description:

This group takes placebo for 12 weeks.

Treatment:

Dietary Supplement: Placebo