NCT02817074

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
604

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2016

Completed
6 months until next milestone

Study Start

First participant enrolled

January 1, 2017

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

4.5 years

First QC Date

June 23, 2016

Last Update Submit

March 21, 2022

Conditions

Cognitive DeclineDementiaAlzheimer DiseaseVascular Dementia

Outcome Measures

Primary Outcomes (2)

  • 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

  • Change in specific cognitive domains

    Change in specific cognitive domains: episodic memory, semantic memory, perceptual speed, and executive function

    3 years

Secondary Outcomes (1)

  • Change in brain MRI total brain /intracranial volume (cubic centimeters) and hippocampal/intracranial volume (cubic centimeters)

    3 years

Other Outcomes (13)

  • Exploratory aim 1: Incidence of cardiovascular disease

    3 years

  • Exploratory aim 2a: Blood pressure

    3 years

  • Exploratory aim 2b: Total cholesterol

    3 years

  • +10 more other outcomes

Study Arms (2)

MIND Diet +Weight loss

ACTIVE COMPARATOR

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 DietBehavioral: Mild Weight Loss

Usual Diet + Weight Loss

PLACEBO COMPARATOR

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

Behavioral: Mild Weight Loss

Interventions

MIND DietBEHAVIORAL

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

MIND Diet +Weight loss
Mild Weight LossBEHAVIORAL

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

MIND Diet +Weight lossUsual Diet + Weight Loss

Eligibility Criteria

Age65 Years - 84 Years
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rush University

Chicago, Illinois, 60612, United States

Location

Harvard School of Public Health

Boston, Massachusetts, 02115, United States

Location

Related Publications (10)

  • 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.

    PMID: 26086182BACKGROUND

  • 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.

    PMID: 25681666BACKGROUND

  • 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.

    PMID: 41058007DERIVED

  • 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 Dec;49(12):2503-2510. doi: 10.1038/s41366-025-01902-6. Epub 2025 Oct 3.

    PMID: 41044190DERIVED

  • 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 Nov;122(5):1289-1297. doi: 10.1016/j.ajcnut.2025.08.012. Epub 2025 Aug 27.

    PMID: 40876538DERIVED

  • 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.

    PMID: 37466280DERIVED

  • 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.

    PMID: 34527222DERIVED

  • 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.

    PMID: 34113981DERIVED

  • 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.

    PMID: 33835152DERIVED

  • 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.

    PMID: 33434704DERIVED

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer DiseaseDementia, Vascular

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesCerebrovascular DisordersIntracranial ArteriosclerosisIntracranial Arterial DiseasesLeukoencephalopathiesArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Lisa L Barnes, Ph.D.

    Rush University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 23, 2016

First Posted

June 29, 2016

Study Start

January 1, 2017

Primary Completion

June 30, 2021

Study Completion

June 30, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will share

Electronic data will be made available after trial completion

Locations

US(2)