Phospholipid-rich Dairy Extract for Cognitive Function

NCT07011680 | Recruiting

• 1 other identifier: 12-2024-013
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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?

Conditions

Cognitive Function; Cognitive Decline

Outcome Measures

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

  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.

  12 weeks

Secondary Outcomes (7)

• Change from baseline to 12 weeks in verbal learning test score

  12 weeks

• Change from baseline to 12 weeks in digit span test score

  12 weeks

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

  12 weeks

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

  12 weeks

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

  12 weeks

Study Arms (2)

Milk group

EXPERIMENTAL

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

Dietary Supplement: Phospholipid-rich dairy milk extract

Placebo group

PLACEBO COMPARATOR

This group takes placebo for 12 weeks.

Dietary Supplement: Placebo

Interventions

Phospholipid-rich dairy milk extract DIETARY_SUPPLEMENT

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

Milk group

Placebo DIETARY_SUPPLEMENT

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

Placebo group

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

RECRUITING

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Sang Yeoup Lee, Professor, MD, PhD

  Pusan National University Yangsan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang Yeoup Lee, Professor, MD, PhD

CONTACT

82+55-360-2860; drsaylee@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 1, 2025
• First Posted: June 10, 2025
• Study Start: January 7, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-06

Locations

KR (1)