MIND Diet Intervention to Prevent Alzheimer Disease is a Phase III randomized controlled trial which tests the effects of a 3-year intervention of a hybrid of the Mediterranean and DASH diets, called MIND, on cognitive decline among 604 individuals 65+ years without cognitive impairment who are overweight and have suboptimal diets.
The MIND diet (Mediterranean-DASH Intervention for Neurodegenerative Delay) 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 employs 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 are assessed by measurement of brain macro- and micro-structural integrity in 300 randomly selected participants. Other biochemical markers are assessed in the entire cohort of 604 participants, including: plasma Abeta 42/Abeta 40, brain-derived neurotrophic factor (BDNF) and plasma markers of oxidative stress and inflammation. In addition, the trial examines potential effect mediators and modifiers by a number of cardiovascular risk factors, AD biomarkers, and biological mechanisms.
The 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.
Study Website: http://mind-diet-trial.org/