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MIND Diet Intervention and Cognitive Decline (MIND)

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ClinicalTrials.gov Identifier: NCT02817074
Recruitment Status : Active, not recruiting
First Posted : June 29, 2016
Last Update Posted : April 13, 2021
Sponsor:
Collaborators:
Harvard School of Public Health
Brigham and Women's Hospital
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Lisa L. Barnes, PhD, Rush University Medical Center

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.

Condition or disease Intervention/treatment Phase
Cognitive Decline Dementia Alzheimer Disease Vascular Dementia Behavioral: MIND Diet Behavioral: Mild Weight Loss Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 604 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: MIND Diet Intervention to Prevent Alzheimer's Disease
Actual Study Start Date : January 2017
Estimated Primary Completion Date : April 2021
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Weight Control

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.

  2. Change in specific cognitive domains [ Time Frame: 3 years ]
    Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function


Secondary Outcome Measures :
  1. Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters) [ Time Frame: 3 years ]
    Changes in brain MRI-derived normalized measures of total brain volume (cubic centimeters) and hippocampal volume (cubic centimeters) and white/gray matter, segmented gray matter regions, white matter lesions, and thickness of segmented cortical regions.


Other Outcome Measures:
  1. Exploratory aim 1: Incidence of cardiovascular disease [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the risk of incident cardiovascular disease. Cardiovascular disease is defined as the presence of coronary heart disease, cerebrovascular disease, and/or heart failure.

  2. Exploratory aim 2a: Blood pressure [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of systolic and diastolic blood pressure (mmHg) from the baseline to 6, 12, 24, and 36 months

  3. Exploratory aim 2b: Total cholesterol [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of total cholesterol (mg/dL), in plasma from the baseline to 3 and 36 months.

  4. Exploratory aim 2c: Low-density lipoprotein (LDL) [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of LDL (mg/dL) in plasma from the baseline to 3 and 36 months.

  5. Exploratory aim 2d: High-density lipoprotein (HDL) [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of HDL (mg/dL) in plasma from the baseline to 3 and 36 months.

  6. Exploratory aim 2e: Hemoglobin A1c (HbA1c) [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of HbA1c levels in plasma from the baseline to 3 and 36 months.

  7. Exploratory aim 3: Plasma amyloid beta (Abeta) [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of plasma Abeta 40 (pg/ml), Abeta42 (pg/ml), and ratio Abeta40/Abeta42 from the baseline to 3 and 36 months.

  8. Exploratory aim 4a: C-Reactive Protein (CRP) [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of CRP (mg/L) levels in plasma from the baseline to 3 and 36 months.

  9. Exploratory aim 4b: Interleukin 6 (IL-6) [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of plasma IL-6 (pg/mL) from the baseline to 3 and 36 months.

  10. Exploratory aim 4c: Oxidized LDL [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of oxidized LDL (mg/dl) in plasma from the baseline to 3 and 36 months.

  11. Exploratory aim 4d: Estimated glomerular filtration rate (eGFR) [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of eGFR (mg/dL) from the baseline to 3 and 36 months.

  12. Exploratory aim 4e: Brain-derived neurotrophic factor [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of plasma Brain-derived neurotrophic factor (pg/mL) from the baseline to 3 and 36 months.

  13. Exploratory aim 4f: Adiponectin [ Time Frame: 3 years ]
    To evaluate the role of MIND diet on the change of plasma adiponectin (mg/L) levels from the baseline to 3 and 36 months.



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Ages Eligible for Study:   65 Years to 84 Years   (Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02817074


Locations
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United States, Illinois
Rush University
Chicago, Illinois, United States, 60612
United States, Massachusetts
Harvard School of Public Health
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Rush University Medical Center
Harvard School of Public Health
Brigham and Women's Hospital
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Lisa L Barnes, Ph.D. Rush University
Publications:
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Responsible Party: Lisa L. Barnes, PhD, Principal Investigator, Rush University Medical Center
ClinicalTrials.gov Identifier: NCT02817074    
Other Study ID Numbers: R01 AG051641
1R01AG052583-01 ( U.S. NIH Grant/Contract )
First Posted: June 29, 2016    Key Record Dates
Last Update Posted: April 13, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Electronic data will be made available after trial completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Dementia, Vascular
Cognitive Dysfunction
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cognition Disorders
Cerebrovascular Disorders
Intracranial Arteriosclerosis
Intracranial Arterial Diseases
Leukoencephalopathies
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases