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MIND Diet Intervention and Cognitive Decline (MIND)

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by Martha Clare Morris, Rush University Medical Center
Sponsor:
Collaborators:
Harvard School of Public Health
Brigham and Women's Hospital
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Martha Clare Morris, Rush University Medical Center
ClinicalTrials.gov Identifier:
NCT02817074
First received: June 23, 2016
Last updated: January 13, 2017
Last verified: January 2017
  Purpose
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.

Condition Intervention Phase
Cognitive Decline Dementia Alzheimer Disease Vascular Dementia Behavioral: MIND Diet Behavioral: Mild Weight Loss Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: MIND Diet Intervention to Prevent Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Martha Clare Morris, Rush University Medical Center:

Primary Outcome Measures:
  • Change in global cognitive score [ Time Frame: 3 years ]
    3-year change in global cognitive score (standardized units) based on battery of 12 cognitive tests. Global cognitive score is based on the average of z-scores of the individual test scores.


Secondary Outcome Measures:
  • Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters) [ Time Frame: 3 years ]
    3-year changes in brain MRI-derived normalized measures of total brain volume (cubic centimeters) and hippocampal volume (cubic centimeters)


Estimated Enrollment: 600
Study Start Date: January 2017
Estimated Study Completion Date: March 2021
Estimated Primary Completion Date: December 2020 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: MIND Diet +Weight loss
3-year intervention of dietary counseling to adhere to the MIND diet plus reduce calorie intake by 250 kcal /day for mild weight loss
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
Placebo Comparator: Usual Diet + Weight Loss
3-year intervention of usual diet + counseling to reduce calorie intake by 250 kcal/day for mild weight loss
Behavioral: Mild Weight Loss
3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss

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.
  Eligibility

Ages Eligible for Study:   65 Years to 84 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • heavy alcohol use
  • severe illness
  • cognitively impaired
  • psychiatric illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02817074

Contacts
Contact: Martha C Morris, Sc.D. 312-942-3223 Martha_C_Morris@rush.edu
Contact: Chiquia Hollings 312-943-2123 Chiquia_S_Hollings@rush.edu

Locations
United States, Illinois
Rush University Recruiting
Chicago, Illinois, United States, 60612
Contact: Martha C Morris, Sc.D.    312-942-3223    Martha_C_Morris@rush.edu   
Contact: Chiquia S Hollings    312-943-2123    Chiquia_S_Hollings@rush.edu   
Sub-Investigator: Lisa L Barnes, Ph.D.         
Sub-Investigator: Neelum L Aggarwal, M.D.         
Sub-Investigator: Konstantinos Arfanakis, Ph.D.         
United States, Massachusetts
Harvard School of Public Health Recruiting
Boston, Massachusetts, United States, 02115
Contact: Frank M Sacks, MD    617-432-1420    fsacks@hsph.harvard.edu   
Contact: Louise Bishop    : 617-998-1043    lbishop@hsph.harvard.edu   
Sponsors and Collaborators
Rush University Medical Center
Harvard School of Public Health
Brigham and Women's Hospital
National Institute on Aging (NIA)
  More Information

Publications:
Responsible Party: Martha Clare Morris, Professor, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02817074     History of Changes
Other Study ID Numbers: R01 AG051641
1R01AG052583-01 ( U.S. NIH Grant/Contract )
Study First Received: June 23, 2016
Last Updated: January 13, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Electronic data will be made available after trial completion

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Cognition Disorders
Dementia, Vascular
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 17, 2017