NCT02817074

MIND Diet Intervention and Cognitive Decline

MIND Diet Intervention to Prevent Alzheimer's Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 604 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: 65 Years – 84 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Cognitive Decline
• Dementia
• Alzheimer Disease
• Vascular Dementia

Interventions

Type	Name	Description
BEHAVIORAL	MIND Diet	3-year dietary counseling to adhere to the MIND diet and for mild weight loss
BEHAVIORAL	Mild Weight Loss	3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Timeline

• Start date: 2017-01-01
• Primary completion: 2021-06-30
• Completion: 2021-06-30
• First posted: 2016-06-29
• Last updated: 2022-03-23

Locations

2 sites across 1 country: United States