Skip to main content
Clinical Trials/NCT02817074
NCT02817074CompletedNot Applicable

MIND Diet Intervention to Prevent Alzheimer's Disease

Rush University Medical Center4 sites in 1 country604 target enrollmentStarted: January 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
604
Locations
4
Primary Endpoint
Change in specific cognitive domains

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
65 Years to 84 Years (Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

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

Exclusion Criteria

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

Outcomes

Primary Outcomes

Change in specific cognitive domains

Time Frame: 3 years

Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function

Change in global cognitive function (composite score)

Time Frame: 3 years

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.

Secondary Outcomes

  • Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters)(3 years)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lisa L. Barnes, PhD

Principal Investigator

Rush University Medical Center

Study Sites (4)

Loading locations...

Similar Trials