Multicultural Healthy Diet to Reduce Cognitive Decline

Cognitive Decline Clinical Trial

— MHD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03240406
• Other study ID #: 2016-6613
• Secondary ID: R01AG055527
• Status: Completed
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: July 3, 2023

Study information

• Verified date: October 2023
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: July 3, 2023
• Est. primary completion date: July 3, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Change
• Cognitive Decline
• Cognitive Dysfunction
• Diet Modification

Intervention

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

Locations

Country	Name	City	State
United States	Albert Einstein College of Medicine	Bronx	New York

Sponsors (5)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine	Kaiser Permanente, National Institute on Aging (NIA), Penn State University, University of Minnesota

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	9 months post baseline