NCT07011680招募中不适用
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.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- 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
研究概览
简要总结
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?
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
时间窗: 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.
次要结局
- Change from baseline to 12 weeks in serum brain-derived neurotrophic factor (BDNF) concentration(12 weeks)
- Change from baseline to 12 weeks in serum malondialdehyde (MDA) concentration(12 weeks)
- Change from baseline to 12 weeks in serum superoxide dismutase (SOD) activity(12 weeks)
- 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)
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital
研究点 (2)
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