Effects of Mediterranean Diet on Physical and Cognitive Functions in Community-dwelling Older People With Subjective Cognitive Decline - a Randomized Controlled Cross-over Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 2
- 主要终点
- Physical function 2 - handgrip strength change
研究概览
简要总结
Research Questions:
- Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?
- What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?
Research Objective:
Conduct a cross-over randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline (SCD) in the community. Utilize brain MRI and circulatory biomarkers measurements to elucidate the underlying mechanisms.
详细描述
Research Questions:
- Due to the fact that most participants in past clinical trials on the Mediterranean diet were cognitively healthy individuals, and while the observed effects were significant, they were not particularly substantial, does the Mediterranean diet have similarly significant and more pronounced effects on both physical and cognitive functions in older adults with subjective cognitive decline (SCD)?
- What is the mechanism behind the effects of the Mediterranean diet on physical or/and cognitive function? Is it through vascular protection or improvements in brain structure/brain network function?
Research Objective:
Conduct a randomized controlled trial to investigate the effects of a three-month Mediterranean diet on the physical and cognitive functions of older adults with subjective cognitive decline (SCD) in the community. Utilize brain MRI to elucidate the underlying mechanisms.
Participants inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjective cognitive decline (SCD)-plus subjects, individuals must meet five criteria:
- •Subjective memory decline without impairment in other cognitive domains (MMSE > 26; MMSE > 14 for <6 years of education).
- •Onset of subjective cognitive decline within the past 5 years.
- •Age at the onset of subjective cognitive decline is >60 years.
- •Concern and preoccupation with memory decline.
- •Perceived functional decline relative to peers and meet one of three criteria: a. Caregiver perceives cognitive decline; b. Carries APOE ε4 genotype; c. Clinical evidence of preclinical Alzheimer's disease biomarkers.
排除标准
- •Exclude individuals who:
- •Cannot comply with or accept the dietary intervention (e.g., dietary restrictions, vegetarianism, lactose intolerance).
- •Have walking speed ≤ 0.3 meters/second.
- •Have significant medical conditions affecting physical and cognitive functions.
- •Have chronic kidney disease (eGFR <30 ml/min/1.73m2) or undergo dialysis.
- •Experience poorly controlled cardiovascular diseases or malignant tumors.
- •Have severe visual and hearing impairments preventing assessments.
- •Have undergone hormone therapy in the preceding three months or are expected to during the trial.
研究组 & 干预措施
Mediterranean diet phase followed by regular diet phase
Three-month of M phase, one month of washout and three month of R phase
干预措施: Mediterranean diet (Other)
Mediterranean diet phase followed by regular diet phase
Three-month of M phase, one month of washout and three month of R phase
干预措施: Regular diet (Other)
Regular diet phase followed by Mediterranean diet phase
Three-month of R phase followed by three month of M phase
干预措施: Mediterranean diet (Other)
Regular diet phase followed by Mediterranean diet phase
Three-month of R phase followed by three month of M phase
干预措施: Regular diet (Other)
结局指标
主要结局
Physical function 2 - handgrip strength change
时间窗: Three month of allocated diet phase
Handgrip strength measurements
Brain MRI neurovascular structural change - microvascular density
时间窗: Three month of allocated diet phase
arteriolar and venular densities
Physical function 1 - gait speed change
时间窗: Three month of allocated diet phase
Gait speed measurements
Cognitive functional change
时间窗: Three month of allocated diet phase
Subjective and objective cognitive functional measurements (MMSE and comprehensive neuropsychological tests for verbal memory, attention, visuospatial function, executive function, and language)
Physical function 3 - stand from chair speed change
时间窗: Three month of allocated diet phase
Five times of stand from chair speed measurements
Brain MRI functional change - total and regional voxel-based brain functional features change
时间窗: Three month of allocated diet phase
Resting functional MRI signal analsyes
Brain MRI neurovascular lesion change - small vessel disease markers
时间窗: Three month of allocated diet phase
white matter hyperintensities, lacune and cerebral microbleeds assessments
Brain MRI structural change - total and regional voxel-based brain parenchymal features change
时间窗: Three month of allocated diet phase
Brain gray matter/white matter volumes and diffusion tensor imaging measurements
次要结局
- AD circulatory biomarkers(Three month of allocated diet phase)
研究者
Chih-Ping Chung
Professor M.D.
Taipei Veterans General Hospital, Taiwan