NCT03240406

Multicultural Healthy Diet to Reduce Cognitive Decline

Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 393 (actual)
• Sponsor: Albert Einstein College of Medicine · Academic / Other
• Sex: All
• Age: 40 Years – 65 Years
• Healthy volunteers: Accepted

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 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

• Diet Modification
• Cognitive Decline
• Cognitive Change

Interventions

Type	Name	Description
OTHER	Multicultural Healthy Diet	An anti-inflammatory dietary pattern consists of a dietary pattern that has high anti-inflammatory potential
OTHER	Usual Diet plus Self-Care	Usual diet plus sessions that focus on self-care such as dealing with aches and pains of aging.

Timeline

• Start date: 2018-10-02
• Primary completion: 2023-07-03
• Completion: 2023-08-30
• First posted: 2017-08-07
• Last updated: 2024-12-12
• Results posted: 2024-12-12

Locations

1 site across 1 country: United States