MIND Diet Intervention and Cognitive Decline

Rush

Status: Completed

Conditions: Alzheimer Disease; Vascular Dementia; Cognitive Decline; Dementia

Treatments: Behavioral: Mild Weight Loss; Behavioral: MIND Diet

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02817074

1R01AG052583-01 (U.S. NIH Grant/Contract)

R01AG051641

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 604 patients

Sex: All

Ages: 65 to 84 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• family history of dementia
• BMI >=25
• suboptimal diet

Exclusion criteria

• heavy alcohol use
• severe illness
• cognitively impaired
• psychiatric illness

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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604 participants in 2 patient groups, including a placebo group

MIND Diet +Weight loss

Active Comparator group

Description:

3-year intervention of dietary counseling to adhere to the MIND diet plus reduce calorie intake by 250 kcal /day for mild weight loss

Treatment:

Behavioral: MIND Diet

Behavioral: Mild Weight Loss

Usual Diet + Weight Loss

Placebo Comparator group

Description:

3-year intervention of usual diet + counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Treatment:

Behavioral: Mild Weight Loss