This study is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease.
This is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease. Patients who eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into three groups by a 1:1:1 ratio. Patients in first arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. Patients in the second arm will receive intervention of exercise and cognitive training. Patients in the third arm will receive regular health advice. We hypothesize that the multi-domain intervention will reduce impairment in the study group compared to the control group during the 2-year intervention period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
180
Low inflammatory-index diet
Guided muscle strength training and stretching exercises
Cognitive training will be implemented in person
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
RECRUITINGChange from baseline global cognitive function at one year
Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE)
Time frame: One year
Change from baseline memory at one year
Change from baseline verbal memory using the Auditory verbal learning test (AVLT)
Time frame: One year
Change from baseline visual spatial ability and visual memory at one year
Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)
Time frame: One year
Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test
Executive function
Time frame: One year
Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)
Neural connectivity by functional MRI
Time frame: One year
Changes in structural brain MRI including volume of hippocampus and other specific brain regions
Brain structure by MRI
Time frame: One year
Changes in Inflammatory biomarkers
Serum interleukins and tumor necrosis factors
Time frame: One year
Changes in gut microbiota
Number of genera and abundance of microbiota in feces and blood
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Time frame: One year
Changes in Metabolic biomarkers
Low-density lipoprotein, high-density lipoprotein, and total cholesterol
Time frame: One year