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Multicultural Healthy Diet to Reduce Cognitive Decline

NCT ID: NCT03240406

Last Updated: 2024-12-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

393 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2023-08-30

Brief Summary

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This is a pilot randomized controlled clinical trial is designed to investigate whether the Multicultural Healthy Diet (MHD), an anti-Inflammatory diet tailored to a multi-cultural population, can improve cognitive functioning in a middle aged (40-65 yr) urban population in Bronx, New York compared to a usual diet.

Detailed Description

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The Multicultural Healthy Diet (MHD) is a pilot randomized controlled clinical trial designed to test the effects of an 18 month intervention on cognitive function among 290 middle-aged individuals (40-65 yr). MHD is an anti-inflammatory diet tailored to a multicultural population. The emphasis of the intervention is on plant-based foods and limited animal and high saturated fat foods with focus on anti-inflammatory foods/food components specific to the cultural context of the participants. The trial will employ a parallel group design comparing the effects of the dietary intervention (MHD) on cognitive status to those of the control diet or usual diet plus modules on self-care matters such as dealing with aches and pains of aging, obtaining a health care proxy ,etc. To show that MHD can be adapted to this population serum biomarkers indicative of the MHD diet pattern such as fatty acid profile as well as other key nutrition biomarkers will be evaluated. Other aims include testing whether the MHD intervention can benefit cognitive function using real-time ambulatory assessments. The investigators will also assess plasma and serum markers of inflammation. Components of the MHD diet that are associated with stable or improved measures of cognition will also be evaluated. The clinical site for the proposed study is at the Albert Einstein College of Medicine; the ambulatory cognitive assessment reading center is at Pennsylvania State University, State College; the statistical core is at the Kaiser Permanente Washington Health Research Institute and the laboratory for biospecimen analysis is at the University of Minnesota.

Conditions

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Diet Modification Cognitive Decline Cognitive Change

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This is a pilot randomized clinical trial to the effects of an anti-inflammatory diet on cognition in a middle-aged cohort. The comparison arm will receive information on self-care matters such as aches and pains of aging.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The research clinician who assesses cognitive status needs to be blinded to assignment.

Study Groups

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Anti-inflammatory dietary intervention

18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,

Group Type ACTIVE_COMPARATOR

Multicultural Healthy Diet

Intervention Type OTHER

An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential

Usual Diet plus Self-Care

18 month intervention of usual diet plus self-care modules

Group Type PLACEBO_COMPARATOR

Usual Diet plus Self-Care

Intervention Type OTHER

Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.

Interventions

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Multicultural Healthy Diet

An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential

Intervention Type OTHER

Usual Diet plus Self-Care

Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* living, working, attending school or visiting Co-op City, Bronx (e.g. for shopping, doctors' visits, etc.) or communities neighboring Co-op City and between 40-65 yr of age
* willingness to accept assignment to intervention or comparison diet group
* willingness to participate in a study where weight loss is not a primary goal

Exclusion Criteria

* cognitively impaired
* history of traumatic brain injury
* psychiatric illness
* history of diabetes and experiencing hypoglycemia
* liver disease
* uncontrolled hypertension as defined as blood pressure \> 140/90 mm Hg
* history of cardiovascular disease that affects physical functioning
* severe chronic illness
* low literacy
* history of alcohol or drug dependence
* hematologic disease or malignancy not in remission for more than 5 years
* visual, auditory, or motor impairment that precludes cognitive testing.
* chronic kidney disease on dialysis or special diet
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Penn State University

OTHER

Sponsor Role collaborator

Kaiser Permanente

OTHER

Sponsor Role collaborator

University of Minnesota

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

Sponsor Role collaborator

Albert Einstein College of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Mossavar-Rahmani

Professor of Epidemiology & Population Health

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yasmin Mossavar-Rahmani, Ph.D, RD

Role: PRINCIPAL_INVESTIGATOR

Albert Einstein College of Medicine

Locations

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Albert Einstein College of Medicine

The Bronx, New York, United States

Site Status

Countries

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United States

References

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Mossavar-Rahmani Y, Shaw PA, Hakun JG, Katz MJ, Wylie-Rosett J, Sliwinski MJ. Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk: Study protocol for a pilot randomized controlled trial. Contemp Clin Trials. 2023 Jan;124:107006. doi: 10.1016/j.cct.2022.107006. Epub 2022 Nov 14.

Reference Type BACKGROUND
PMID: 36396064 (View on PubMed)

Mossavar-Rahmani Y, Hyun N, Hakun JG, Katz MJ, Pavlovic JM, Zetterberg H, Wang Z, Yang JB, Wylie-Rosett J, Hebert JR, Sliwinski MJ, Shaw PA. The effects of the Multicultural Healthy Diet on cognitive decline and Alzheimer's disease risk: a phase II randomized controlled trial in middle-aged adults. Am J Clin Nutr. 2025 Jul;122(1):48-59. doi: 10.1016/j.ajcnut.2025.05.011. Epub 2025 May 22.

Reference Type DERIVED
PMID: 40412481 (View on PubMed)

Hakun JG, Benson L, Qiu T, Elbich DB, Katz M, Shaw PA, Sliwinski MJ, Mossavar-Rahmani Y. Cognitive Health Benefits of Everyday Physical Activity in a Diverse Sample of Middle-Aged Adults. Ann Behav Med. 2025 Jan 4;59(1):kaae059. doi: 10.1093/abm/kaae059.

Reference Type DERIVED
PMID: 39427230 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R01AG055527

Identifier Type: NIH

Identifier Source: secondary_id

View Link

K99AG056670

Identifier Type: NIH

Identifier Source: secondary_id

View Link

UL1TR002556

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2016-6613

Identifier Type: -

Identifier Source: org_study_id