MIND Diet Intervention and Cognitive Decline

Alzheimer Disease Clinical Trial

— MIND  

Official title:

MIND Diet Intervention to Prevent Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02817074
• Other study ID #: R01 AG051641
• Secondary ID: 1R01AG052583-01
• Status: Completed
• Phase: N/A
• Start date: January 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2022
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 604
• Est. completion date: June 30, 2021
• Est. primary completion date: June 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years to 84 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Cognitive Decline
• Cognitive Dysfunction
• Dementia
• Dementia, Vascular
• Vascular Dementia

Intervention

Behavioral:
• MIND Diet
3-year dietary counseling to adhere to the MIND diet and for mild weight loss
• Mild Weight Loss
3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Locations

Country	Name	City	State
United States	Harvard School of Public Health	Boston	Massachusetts
United States	Rush University	Chicago	Illinois

Sponsors (4)

Lead Sponsor	Collaborator
Rush University Medical Center	Brigham and Women's Hospital, Harvard School of Public Health (HSPH), National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (2)

Morris MC, Tangney CC, Wang Y, Sacks FM, Barnes LL, Bennett DA, Aggarwal NT. MIND diet slows cognitive decline with aging. Alzheimers Dement. 2015 Sep;11(9):1015-22. doi: 10.1016/j.jalz.2015.04.011. Epub 2015 Jun 15. — View Citation

Morris MC, Tangney CC, Wang Y, Sacks FM, Bennett DA, Aggarwal NT. MIND diet associated with reduced incidence of Alzheimer's disease. Alzheimers Dement. 2015 Sep;11(9):1007-14. doi: 10.1016/j.jalz.2014.11.009. Epub 2015 Feb 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Exploratory aim 1: Incidence of cardiovascular disease	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.	3 years
Other	Exploratory aim 2a: Blood pressure	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 years
Other	Exploratory aim 2b: Total cholesterol	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.	3 years
Other	Exploratory aim 2c: Low-density lipoprotein (LDL)	To evaluate the role of MIND diet on the change of LDL (mg/dL) in plasma from the baseline to 3 and 36 months.	3 years
Other	Exploratory aim 2d: High-density lipoprotein (HDL)	To evaluate the role of MIND diet on the change of HDL (mg/dL) in plasma from the baseline to 3 and 36 months.	3 years
Other	Exploratory aim 2e: Hemoglobin A1c (HbA1c)	To evaluate the role of MIND diet on the change of HbA1c levels in plasma from the baseline to 3 and 36 months.	3 years
Other	Exploratory aim 3: Plasma amyloid beta (Abeta)	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.	3 years
Other	Exploratory aim 4a: C-Reactive Protein (CRP)	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.	3 years
Other	Exploratory aim 4b: Interleukin 6 (IL-6)	To evaluate the role of MIND diet on the change of plasma IL-6 (pg/mL) from the baseline to 3 and 36 months.	3 years
Other	Exploratory aim 4c: Oxidized LDL	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.	3 years
Other	Exploratory aim 4d: Estimated glomerular filtration rate (eGFR)	To evaluate the role of MIND diet on the change of eGFR (mg/dL) from the baseline to 3 and 36 months.	3 years
Other	Exploratory aim 4e: Brain-derived neurotrophic factor	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.	3 years
Other	Exploratory aim 4f: Adiponectin	To evaluate the role of MIND diet on the change of plasma adiponectin (mg/L) levels from the baseline to 3 and 36 months.	3 years
Primary	Change in global cognitive function (composite score)	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.	3 years
Primary	Change in specific cognitive domains	Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function	3 years
Secondary	Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters)	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.	3 years