MIND Diet Intervention and Cognitive Decline
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Alzheimer Disease, Cognitive Studies, Cognitive Studies, Cardiology, Neurology |
| Therapuetic Areas: | Cardiology / Vascular Diseases, Neurology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 65 - 84 |
| Updated: | 6/28/2018 |
| Start Date: | January 2017 |
| End Date: | April 2021 |
MIND Diet Intervention to Prevent Alzheimer's Disease
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.
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.
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.
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.
Inclusion Criteria:
- family history of dementia
- BMI >=25
- suboptimal diet
Exclusion Criteria:
- heavy alcohol use
- severe illness
- cognitively impaired
- psychiatric illness
We found this trial at
2
sites
Click here to add this to my saved trials
Click here to add this to my saved trials