MIND Diet Intervention and Cognitive Decline (MIND)
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ClinicalTrials.gov Identifier: NCT02817074 |
Recruitment Status :
Completed
First Posted : June 29, 2016
Last Update Posted : March 23, 2022
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Condition or disease | Intervention/treatment | Phase |
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Cognitive Decline Dementia Alzheimer Disease Vascular Dementia | Behavioral: MIND Diet Behavioral: Mild Weight Loss | Not Applicable |
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 |
Actual Primary Completion Date : | June 30, 2021 |
Actual Study Completion Date : | June 30, 2021 |

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
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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
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Behavioral: Mild Weight Loss
3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss |
- 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.
- 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 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.
- 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.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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 |
Inclusion Criteria:
- family history of dementia
- BMI >=25
- suboptimal diet
Exclusion Criteria:
- heavy alcohol use
- severe illness
- cognitively impaired
- psychiatric illness

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
United States, Illinois | |
Rush University | |
Chicago, Illinois, United States, 60612 | |
United States, Massachusetts | |
Harvard School of Public Health | |
Boston, Massachusetts, United States, 02115 |
Principal Investigator: | Lisa L Barnes, Ph.D. | Rush University |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Lisa L. Barnes, PhD, Principal Investigator, Rush University Medical Center |
ClinicalTrials.gov Identifier: | NCT02817074 |
Other Study ID Numbers: |
R01AG051641 ( U.S. NIH Grant/Contract ) 1R01AG052583-01 ( U.S. NIH Grant/Contract ) |
First Posted: | June 29, 2016 Key Record Dates |
Last Update Posted: | March 23, 2022 |
Last Verified: | March 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Electronic data will be made available after trial completion |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 |