Clinical trial NCT03240406: Multicultural Healthy Diet to Reduce Cognitive Decline
Official title: Multicultural Healthy Diet to Reduce Cognitive Decline & Alzheimer's Disease Risk
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diet Modification
Cognitive Decline
Cognitive Change
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Penn State University
name: Kaiser Permanente
name: University of Minnesota
name: National Institute on Aging (NIA)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2017-08-07
Enrollment: 393
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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.

Eligibility 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

Primary outcomes:
measure: Change in Mean Global Composite Cognition Score From Baseline
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
Secondary outcomes:
measure: Dietary Inflammatory Index (DII) Score
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Energy-Adjusted DII Score
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Total Serum Folate Levels
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: α-Tocopherol Levels
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: α-Carotenoid Levels
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Vitamin B12 Levels
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Fatty Acid Profile
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Serum Sodium
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Total Moisture
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Energy
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Protein
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Dark Green Vegetables
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Total Fats
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Solid Fats
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Carbohydrates
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Total Folate From Food
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Non-food Folate
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Vitamin B-12
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Alpha Carotene
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Beta Carotene
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Retinol
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Beta Cryptoxanthin
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Lycopene
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E)
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: EPA (P205)
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: DHA (P226)
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: DPA (P225)
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Beans and Peas (Legumes)
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Whole Grains
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Cured Meats
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Poultry
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Nuts and Seeds
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Cheeses
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Self-reported Diet Components and Food Groups: Added Sugars
timeFrame: Baseline (Burst 1) and 9 months (Burst 2)
measure: Symbol Search Task Performance
timeFrame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
measure: Grid Memory Task Performance
timeFrame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
measure: Color Shapes Task Performance
timeFrame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Albert Einstein College of Medicine
state: New York
Study officials:
affiliation: Albert Einstein College of Medicine
name: Yasmin Mossavar-Rahmani, Ph.D, RD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.