Phospholipid-rich Dairy Extract for Cognitive Function

NCT ID: NCT07011680

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-07
• Study Completion Date: 2026-12-31

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

Conditions

Cognitive Function; Cognitive Decline

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: TRIPLE

Study Groups

Milk group

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

Group Type: EXPERIMENTAL

Phospholipid-rich dairy milk extract

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

This group takes placebo for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Phospholipid-rich dairy milk extract

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pusan National University Yangsan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sang Yeoup Lee

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sang Yeoup Lee, Professor, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pusan National University Yangsan Hospital

Locations

Pusan National University Yangsan Hospital

Yangsan, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Sang Yeoup Lee, Professor, MD, PhD

Role: CONTACT

drsaylee@gmail.com

82+55-360-2860

Facility Contacts

Sang Yeoup Lee, MD, PhD

Role: primary

drsaylee@gmail.com

82-55-360-2860

Other Identifiers

12-2024-013

Identifier Type: -

Identifier Source: org_study_id