MIND Diet Intervention and Cognitive Decline

NCT ID: NCT02817074

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 604 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-01-31
• Study Completion Date: 2021-06-30

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.

Conditions

Cognitive Decline; Dementia; Alzheimer Disease; Vascular Dementia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

MIND Diet

Intervention Type: BEHAVIORAL

3-year dietary counseling to adhere to the MIND diet and for mild weight loss

Mild Weight Loss

Intervention Type: BEHAVIORAL

3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Usual Diet + Weight Loss

3-year intervention of usual diet + counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Group Type: PLACEBO_COMPARATOR

Mild Weight Loss

Intervention Type: BEHAVIORAL

3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Interventions

MIND Diet

3-year dietary counseling to adhere to the MIND diet and for mild weight loss

Intervention Type: BEHAVIORAL

Mild Weight Loss

3-year dietary counseling to reduce calorie intake by 250 kcal/day for mild weight loss

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

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

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 84 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Harvard School of Public Health (HSPH)

OTHER

Sponsor Role: collaborator

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Lisa L. Barnes, PhD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lisa L Barnes, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rush University

Locations

Rush University

Chicago, Illinois, United States

Harvard School of Public Health

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26086182 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25681666 (View on PubMed)

Halloway S, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL, Dhana K. Effect modifiers of the MIND diet for cognition in older adults: The MIND diet trial. Alzheimers Dement. 2025 Oct;21(10):e70731. doi: 10.1002/alz.70731.

Reference Type: DERIVED

PMID: 41058007 (View on PubMed)

Dhana K, Aggarwal NT, Voigt RM, Ventrelle J, Rajan KB, Kaddurah-Daouk R, Marcovina SM, Liu X, Agarwal P, Tangney C, Arfanakis K, Sacks FM, Barnes LL. Effect of weight loss through dietary interventions on cardiometabolic health in older adults. Int J Obes (Lond). 2025 Oct 3. doi: 10.1038/s41366-025-01902-6. Online ahead of print.

Reference Type: DERIVED

PMID: 41044190 (View on PubMed)

Liu X, Sacks FM, Beck T, Tangney CC, Willett WC, Yassine H, Dhana K, Aggarwal NT, Rajan KB, Barnes LL. Apolipoprotein E epsilon4-dependent associations between carotenoids and cognitive decline: Findings from the MIND (Mediterranean-DASH Intervention for Neurodegenerative delay) randomized controlled trial. Am J Clin Nutr. 2025 Aug 27:S0002-9165(25)00469-1. doi: 10.1016/j.ajcnut.2025.08.012. Online ahead of print.

Reference Type: DERIVED

PMID: 40876538 (View on PubMed)

Barnes LL, Dhana K, Liu X, Carey VJ, Ventrelle J, Johnson K, Hollings CS, Bishop L, Laranjo N, Stubbs BJ, Reilly X, Agarwal P, Zhang S, Grodstein F, Tangney CC, Holland TM, Aggarwal NT, Arfanakis K, Morris MC, Sacks FM. Trial of the MIND Diet for Prevention of Cognitive Decline in Older Persons. N Engl J Med. 2023 Aug 17;389(7):602-611. doi: 10.1056/NEJMoa2302368. Epub 2023 Jul 18.

Reference Type: DERIVED

PMID: 37466280 (View on PubMed)

Liu X, Dhana K, Furtado JD, Agarwal P, Aggarwal NT, Tangney C, Laranjo N, Carey V, Barnes LL, Sacks FM. Higher circulating alpha-carotene was associated with better cognitive function: an evaluation among the MIND trial participants. J Nutr Sci. 2021 Aug 16;10:e64. doi: 10.1017/jns.2021.56. eCollection 2021.

Reference Type: DERIVED

PMID: 34527222 (View on PubMed)

Lefevre-Arbogast S, Dhana K, Aggarwal NT, Zhang S, Agarwal P, Liu X, Laranjo N, Carey V, Sacks F, Barnes LL, Arfanakis K. Vitamin D Intake and Brain Cortical Thickness in Community-Dwelling Overweight Older Adults: A Cross-Sectional Study. J Nutr. 2021 Sep 4;151(9):2760-2767. doi: 10.1093/jn/nxab168.

Reference Type: DERIVED

PMID: 34113981 (View on PubMed)

Halloway S, Dhana K, Desai P, Agarwal P, Holland T, Aggarwal NT, Evers J, Sacks FM, Carey VJ, Barnes LL. Free-Living Standing Activity as Assessed by Seismic Accelerometers and Cognitive Function in Community-Dwelling Older Adults: The MIND Trial. J Gerontol A Biol Sci Med Sci. 2021 Oct 13;76(11):1981-1987. doi: 10.1093/gerona/glab106.

Reference Type: DERIVED

PMID: 33835152 (View on PubMed)

Liu X, Morris MC, Dhana K, Ventrelle J, Johnson K, Bishop L, Hollings CS, Boulin A, Laranjo N, Stubbs BJ, Reilly X, Carey VJ, Wang Y, Furtado JD, Marcovina SM, Tangney C, Aggarwal NT, Arfanakis K, Sacks FM, Barnes LL. Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) study: Rationale, design and baseline characteristics of a randomized control trial of the MIND diet on cognitive decline. Contemp Clin Trials. 2021 Mar;102:106270. doi: 10.1016/j.cct.2021.106270. Epub 2021 Jan 9.

Reference Type: DERIVED

PMID: 33434704 (View on PubMed)

Other Identifiers

1R01AG052583-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R01AG051641

Identifier Type: NIH

Identifier Source: org_study_id

View Link