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MIND Diet Intervention and Cognitive Decline (MIND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02817074
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : June 26, 2018
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

Tracking Information
First Submitted Date  ICMJE June 23, 2016
First Posted Date  ICMJE June 29, 2016
Last Update Posted Date June 26, 2018
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 25, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 25, 2016)
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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE MIND Diet Intervention and Cognitive Decline
Official Title  ICMJE MIND Diet Intervention to Prevent Alzheimer's Disease
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Cognitive Decline
  • Dementia
  • Alzheimer Disease
  • Vascular Dementia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Behavioral: MIND Diet
    • Behavioral: 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
    Intervention: Behavioral: Mild Weight Loss
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: June 22, 2018)
604
Original Estimated Enrollment  ICMJE
 (submitted: June 25, 2016)
600
Estimated Study Completion Date  ICMJE April 2021
Estimated Primary Completion Date April 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • heavy alcohol use
  • severe illness
  • cognitively impaired
  • psychiatric illness
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 65 Years to 84 Years   (Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02817074
Other Study ID Numbers  ICMJE R01 AG051641
1R01AG052583-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Electronic data will be made available after trial completion
Responsible Party Martha Clare Morris, Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE
  • Harvard School of Public Health
  • Brigham and Women's Hospital
  • National Institute on Aging (NIA)
Investigators  ICMJE
Principal Investigator: Martha C Morris, Sc.D. Rush University
PRS Account Rush University Medical Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP