Multicultural Healthy Diet to Reduce Cognitive Decline (MHD)
Primary Purpose
Diet Modification, Cognitive Decline, Cognitive Change
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Multicultural Healthy Diet
Usual Diet plus Self-Care
Sponsored by

About this trial
This is an interventional prevention trial for Diet Modification
Eligibility Criteria
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
Sites / Locations
- Albert Einstein College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Anti-inflammatory dietary intervention
Usual Diet plus Self-Care
Arm Description
18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,
18 month intervention of usual diet plus self-care modules
Outcomes
Primary Outcome Measures
Change in composite cognition score
9 month change in composite cognition score (standardized unit) based on battery of ambulatory cognitive measures assessing visuospatial working memory, processing speed and short-term associative memory binding. Composite score is based on the average of z-scores of the individual test scores.
Secondary Outcome Measures
Full Information
NCT ID
NCT03240406
First Posted
August 1, 2017
Last Updated
July 11, 2023
Sponsor
Albert Einstein College of Medicine
Collaborators
Penn State University, Kaiser Permanente, University of Minnesota, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT03240406
Brief Title
Multicultural Healthy Diet to Reduce Cognitive Decline
Acronym
MHD
Official Title
Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 2, 2018 (Actual)
Primary Completion Date
July 3, 2023 (Actual)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
Penn State University, Kaiser Permanente, University of Minnesota, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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 markers of oxidative stress and 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diet Modification, Cognitive Decline, Cognitive Change
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
Outcomes Assessor
Masking Description
The research clinician who assesses cognitive status needs to be blinded to assignment.
Allocation
Randomized
Enrollment
290 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Anti-inflammatory dietary intervention
Arm Type
Active Comparator
Arm Description
18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,
Arm Title
Usual Diet plus Self-Care
Arm Type
Placebo Comparator
Arm Description
18 month intervention of usual diet plus self-care modules
Intervention Type
Other
Intervention Name(s)
Multicultural Healthy Diet
Intervention Description
An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential
Intervention Type
Other
Intervention Name(s)
Usual Diet plus Self-Care
Intervention Description
Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.
Primary Outcome Measure Information:
Title
Change in composite cognition score
Description
9 month change in composite cognition score (standardized unit) based on battery of ambulatory cognitive measures assessing visuospatial working memory, processing speed and short-term associative memory binding. Composite score is based on the average of z-scores of the individual test scores.
Time Frame
9 months post baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasmin Mossavar-Rahmani, Ph.D, RD
Organizational Affiliation
Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein College of Medicine
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines
IPD Sharing Time Frame
Reasonable time after completion of data analysis and key manuscripts
IPD Sharing Access Criteria
Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines.
Citations:
PubMed Identifier
36396064
Citation
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.
Results Reference
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Multicultural Healthy Diet to Reduce Cognitive Decline
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