Multicultural Healthy Diet to Reduce Cognitive Decline (MHD)
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ClinicalTrials.gov Identifier: NCT03240406 |
Recruitment Status :
Active, not recruiting
First Posted : August 7, 2017
Last Update Posted : October 14, 2022
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Condition or disease | Intervention/treatment | Phase |
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Diet Modification Cognitive Decline Cognitive Change | Other: Multicultural Healthy Diet Other: Usual Diet plus Self-Care | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 290 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 : | June 30, 2023 |
Estimated Study Completion Date : | August 30, 2023 |

Arm | Intervention/treatment |
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Active Comparator: Anti-inflammatory dietary intervention
18 month intervention of dietary counseling to adhere to the Multicultural Healthy Diet or the anti-inflammatory diet,
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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
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Other: Usual Diet plus Self-Care
Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging. |
- 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 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.

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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 |
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

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
United States, New York | |
Albert Einstein College of Medicine | |
Bronx, New York, United States, 10461 |
Principal Investigator: | Yasmin Mossavar-Rahmani, Ph.D, RD | Albert Einstein College of Medicine |
Responsible Party: | Yasmin Mossavar-Rahmani, Professor of Epidemiology & Population Health, Albert Einstein College of Medicine |
ClinicalTrials.gov Identifier: | NCT03240406 |
Other Study ID Numbers: |
2016-6613 R01AG055527 ( U.S. NIH Grant/Contract ) |
First Posted: | August 7, 2017 Key Record Dates |
Last Update Posted: | October 14, 2022 |
Last Verified: | October 2022 |
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. |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Cognitive Dysfunction Cognition Disorders Neurocognitive Disorders Mental Disorders |