MIND Diet Intervention and Cognitive Decline

Study Overview
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Brief Summary
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Phase III randomized controlled trial designed to test the effects of a 3-year intervention of the MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) on cognitive decline and brain neurodegeneration among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets.

Detailed Description
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Mediterranean-DASH Diet Intervention for Neurodegenerative Delay (MIND) is a Phase III randomized controlled trial designed to test the effects of a 3-year intervention of a hybrid of the Mediterranean and DASH diets, called MIND, on cognitive decline among 600 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets. The proposed MIND diet is a hybrid of the Mediterranean and DASH diets but with selected modifications based on the most compelling evidence in the diet-dementia field. The MIND diet has the same basic components of the DASH and Mediterranean diets, such as emphasis on natural plant-based foods and limited animal and high saturated fat foods, but uniquely specifies green leafy vegetables and berries as well as food component servings that reflect the nutrition-dementia evidence. The trial will employ a parallel group design comparing the effects on cognitive outcomes of the MIND intervention diet plus mild caloric restriction for weight loss to the control diet, usual diet with mild caloric restriction for weight loss. Biological effects of the MIND diet will be assessed by measurement of brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers will be assessed in the entire cohort of 600 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, the trial will examine potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers, and biological mechanisms. The proposed study has two clinical sites, one in Chicago (Rush University) and one in Boston (Harvard University), and centralized laboratories for data coordinating and analyses (Brigham & Women's Hospital), neuroimaging analyses (Rush University), and specialized laboratories for tissue biochemical analyses.

Official Title
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MIND Diet Intervention to Prevent Alzheimer's Disease

Conditions
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Vascular Dementia, Cognitive Decline, Dementia, Alzheimer Disease

Intervention / Treatment
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* Behavioral: MIND Diet
* Behavioral: Mild Weight Loss


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: family history of dementia BMI >=25 suboptimal diet Exclusion Criteria: heavy alcohol use severe illness cognitively impaired psychiatric illness

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 84 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MIND Diet +Weight loss<br>3-year intervention of dietary counseling to adhere to the MIND diet plus reduce calorie intake by 250 kcal /day for mild weight loss | Behavioral: MIND Diet<br>* 3-year dietary counseling to adhere to the MIND diet and for mild weight loss<br>Behavioral: Mild Weight Loss<br>* 3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss<br>|
| Placebo Comparator: Usual Diet + Weight Loss<br>3-year intervention of usual diet + counseling to reduce calorie intake by 250 kcal/day for mild weight loss | Behavioral: Mild Weight Loss<br>* 3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in global cognitive function (composite score) | Global cognitive function assessment is based on a battery of 12 cognitive tests [1. Word list Memory; 2. Word List Recall; 3. Word List Recognition; 4. Logical Memory (East Boston Story Immediate Recall); 5. Logical Memory (East Boston Story Delayed Recall); 6. Verbal Fluency; 7. Multilingual Naming Test; 8. Trail A; 9. Trail B; 10. Flanker Inhibitory Control; 11. Oral Symbol Digit Modalities Test; and 12. Pattern Comparison. Individual test scores will be summarized by calculating the z-score for each test based on the mean and standard deviation of the sample distribution - averaging z-scores across tests will yield a composite score for global cognitive function. Cognitive function will be assessed at the baseline, 6, 12, 24, and 36 months to determine the time-course of cognitive change. | 3 years | 
| Change in specific cognitive domains | Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters) | Changes in brain MRI-derived normalized measures of total brain volume (cubic centimeters) and hippocampal volume (cubic centimeters) and white/gray matter, segmented gray matter regions, white matter lesions, and thickness of segmented cortical regions. | 3 years |