Multicultural Healthy Diet to Reduce Cognitive Decline

NCT03240406 | Completed Results DMC

• 4 other identifiers: 2016-6613R01AG055527K99AG056670UL1TR002556
• Study Type: interventional
• Target: 393
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diet Modification; Cognitive Decline; Cognitive Change

Outcome Measures

Primary Outcomes (1)

• Change in Mean Global Composite Cognition Score From Baseline

  Change in global composite cognition score (standardized unit) is computed as the average of the three domain-specific Z-scores of the participant's performance on three ambulatory cognitive assessments: visuospatial working memory (Dot Grid Memory), processing speed (Symbol Search), and short-term associative memory binding (Color Shapes Task) at 9 months post baseline (Burst 1). Z-scores are centered at a population mean of "0" (i.e., a Z-score of "0" signifies that the data point(s) is equal to the population mean at study baseline for all three tasks in the composite average; positive Z-score group values indicate the number of standard deviations the data point(s) is above the mean and negative Z-score group values indicate the number of standard deviations the data point(s) is below the mean). Mean change in global composite Z-score from baseline will be reported by study arm. Increase in composite Z-scores from baseline are associated with improved cognition.

  Baseline (Burst 1) and 9 months (Burst 2)

Secondary Outcomes (40)

• Dietary Inflammatory Index (DII) Score

  Baseline (Burst 1) and 9 months (Burst 2)

• Energy-Adjusted DII Score

  Baseline (Burst 1) and 9 months (Burst 2)

• Total Serum Folate Levels

  Baseline (Burst 1) and 9 months (Burst 2)

• α-Tocopherol Levels

  Baseline (Burst 1) and 9 months (Burst 2)

• α-Carotenoid Levels

  Baseline (Burst 1) and 9 months (Burst 2)

Study Arms (2)

Anti-inflammatory dietary intervention

ACTIVE COMPARATOR

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

Other: Multicultural Healthy Diet

Usual Diet plus Self-Care

PLACEBO COMPARATOR

18 month intervention of usual diet plus self-care modules

Other: Usual Diet plus Self-Care

Interventions

Multicultural Healthy Diet OTHER

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

Anti-inflammatory dietary intervention

Usual Diet plus Self-Care OTHER

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

Usual Diet plus Self-Care

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Penn State University: collaborator
• Kaiser Permanente: collaborator
• University of Minnesota: collaborator
• National Institute on Aging (NIA): collaborator
• National Center for Advancing Translational Sciences (NCATS): collaborator

Study Sites (1)

Albert Einstein College of Medicine

The Bronx, New York, 10461, United States

Location

Related Publications (3)

• 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.

  PMID: 36396064 BACKGROUND

• 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.

  PMID: 40412481 DERIVED

• 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.

  PMID: 39427230 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Self Care

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation; Health Services; Health Care Facilities Workforce and Services

Results Point of Contact

• Title: Dr. Yasmin Mossavar-Rahmani
• Organization: Albert Einstein College of Medicine

yasmin.mossavar-rahmani@einsteinmed.edu

718-430-2136

Study Officials

• Yasmin Mossavar-Rahmani, Ph.D, RD

  Albert Einstein College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The research clinician who assesses cognitive status needs to be blinded to assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Epidemiology & Population Health

Model Details: 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.

Study Record Dates

• First Submitted: August 1, 2017
• First Posted: August 7, 2017
• Study Start: October 2, 2018
• Primary Completion: July 3, 2023
• Study Completion: August 30, 2023
• Last Updated: December 12, 2024
• Results First Posted: December 12, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Reasonable time after completion of data analysis and key manuscripts
• Access Criteria: Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines.

Locations

US (1)