Table 4.
Variable | Pre-Screen | SV1 | Run-in (Week) | Baseline Visits 1 and 2 | Month 3 | Month 6 | Month 12 | Month 24 | Month 36 | |||
---|---|---|---|---|---|---|---|---|---|---|---|---|
1 | 2 | 3 | 4 | |||||||||
Pre-Screen Eligibility Form | X | |||||||||||
Family History AD | X | |||||||||||
MIND Diet Screener | X | |||||||||||
Consent | X | |||||||||||
Health/Med History | X | |||||||||||
Montreal cognitive assessment | X | |||||||||||
Height | X | X | ||||||||||
Weight | X | X | X | X | X | X | ||||||
Blood Pressure | X | X | X | X | X | |||||||
Waist Circumference | X | X | X | X | X | |||||||
Food Records | X | X | X | X | ||||||||
Diet Randomization | X | |||||||||||
Initial Diet Instruction | X | |||||||||||
MRI1 | X | X | ||||||||||
Diet Intervention | X | X | X | X | X | |||||||
Move Monitor2 | X | X | X | X | ||||||||
Fasting Blood draw 3 | X | X | X | X | X | |||||||
Spot Urine4 | X | X | X | X | X | |||||||
MIND Interview5 | X | X | X | X | X | |||||||
Medication usage questionnaire | X | X | X | X | X | |||||||
24 hr Dietary Recall | X | X | X | X | X | |||||||
Food Frequency Questionnaire | X | X | X | X | X | |||||||
Cognitive Battery6 | X | X | X | X | X |
Sample of 300 participants; 150 at each site; 150 on each diet
Participants from the Rush site will be asked to wear a physical activity sensor (the McRoberts Move Monitor+) on seven consecutive days
Fasting blood collected on participants at baseline and at months 3, 12, 24, and 36. Measures will include abeta40/42, HbA1c, APOE-ε4 genotyping (Baseline ONLY), BDNF, CRP, IL-6, adiponectin, oxidized LDL, total cholesterol, HDL cholesterol, triglycerides, folate, Vitamin B12, tocopherols, carotenoids, and fatty acids.
Spot urine (Total Polyphenols with creatinine) collected on participants at baseline and at months 3, 12, 24, and 36.
MIND Interview includes: Medical history, CES-D 10-item, Neuroticism Scale 4-item, Yale Physical Activity Scale, Cognitive Activities, Functional Status, Demographics, and Tobacco usage.
Cognitive Battery includes: East Boston Immediate Story recall, Multilingual Naming Test, Word List Memory, Word List Recall, Word List Recognition, Pattern Comparison (NIH toolbox) Verbal Fluency, Logical Memory (East Boston delayed story recall), Trails test A and B, Flanker Inhibitory Control (NIH toolbox), Oral Digit Symbol test (NIH toolbox)