Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 40 Years and 65 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • residency in Co-op City, Bronx, age (between 40-65 yrs)
  • willingness to accept assignment to intervention or comparison diet group
  • willingness to participate in a study where weight loss is not a primary goal
  • sub-optimal diet

Exclusion Criteria

  • cognitively impaired
  • history of traumatic brain injury
  • psychiatric illness
  • history of diabetes treated with a medication that may cause hypoglycemia
  • renal or liver disease
  • uncontrolled hypertension as defined as blood pressure > 140/90 mm Hg
  • history of cardiovascular disease
  • 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

Study Design

Phase
N/A
Study Type
Interventional
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.
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)
Masking Description
The research clinician who assesses cognitive status needs to be blinded to assignment.

Arm Groups

ArmDescriptionAssigned Intervention
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.

Recruiting Locations

Albert Einstein College of Medicine
Bronx, New York 10461
Contact:
Vanessa Claris, B.S.
718-430-3823
vanessa.claris@einstein.yu.edu

More Details

NCT ID
NCT03240406
Status
Recruiting
Sponsor
Albert Einstein College of Medicine, Inc.

Study Contact

Yasmin Mossavar-Rahmani, Ph.D., RD
718-430-2136
yasmin.mossavar-rahmani@einstein.yu.edu

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) who have suboptimal diets. 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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.