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Multicultural Healthy Diet to Reduce Cognitive Decline (MHD)

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ClinicalTrials.gov Identifier: NCT03240406
Recruitment Status : Recruiting
First Posted : August 7, 2017
Last Update Posted : July 31, 2019
Sponsor:
Collaborators:
Penn State University
University of Pennsylvania
University of Minnesota
National Institute on Aging (NIA)
Information provided by (Responsible Party):
Yasmin Mossavar-Rahmani, Albert Einstein College of Medicine

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.

Condition or disease Intervention/treatment Phase
Diet Modification Cognitive Decline Cognitive Change Other: Multicultural Healthy Diet Other: Usual Diet plus Self-Care Not Applicable

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 326 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 University of Pennsylvania and the laboratory for biospecimen analysis is at the University of Minnesota.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 326 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Single (Outcomes Assessor)
Masking Description: The research clinician who assesses cognitive status needs to be blinded to assignment.
Primary Purpose: Prevention
Official Title: Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : September 14, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Anti-inflammatory dietary intervention
18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,
Other: Multicultural Healthy Diet
An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential

Placebo Comparator: Usual Diet plus Self-Care
18 month intervention of usual diet plus self-care modules
Other: Usual Diet plus Self-Care
Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.




Primary Outcome Measures :
  1. Change in composite cognition score [ Time Frame: 9 months post baseline ]
    9 month change in composite cognition score (standardized unit) based on battery of ambulatory cognitive measures assessing spatial working memory, short-term memory, processing speed and self-reported mental sharpness. Composite score is based on the average of z-scores of the individual test scores.



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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240406


Contacts
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Contact: Yasmin Mossavar-Rahmani, Ph.D., RD 718-430-2136 yasmin.mossavar-rahmani@einstein.yu.edu
Contact: Mindy Katz, MPH 718-430-3885 mindy.katz@einstein.yu.edu

Locations
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United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10461
Contact: Vanessa Claris, B.S.    718-430-3823    vanessa.claris@einstein.yu.edu   
Contact: Mindy J. Katz, MPH    718-430-3888    mindy.katz@einstein.yu.edu   
Principal Investigator: Yasmin Mossavar-Rahmani, Ph.D.         
Sponsors and Collaborators
Albert Einstein College of Medicine
Penn State University
University of Pennsylvania
University of Minnesota
National Institute on Aging (NIA)
Investigators
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Principal Investigator: Yasmin Mossavar-Rahmani, Ph.D, RD Albert Einstein College of Medicine

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Responsible Party: Yasmin Mossavar-Rahmani, Associate Professor of Clinical Epidemiology & Population Health, Albert Einstein College of Medicine
ClinicalTrials.gov Identifier: NCT03240406     History of Changes
Other Study ID Numbers: 2016-6613
R01AG055527 ( U.S. NIH Grant/Contract )
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: July 31, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines
Supporting Materials: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Anti-Inflammatory Agents