N/A N=290 Randomized Single-blind Prevention

Multicultural Healthy Diet to Reduce Cognitive Decline

Diet Modification · Cognitive Decline · Cognitive Change

Bottom Line

View on ClinicalTrials.gov: NCT03240406 ↗

Enrolled (actual)

290

Serious AEs

6.6%

Results posted

Dec 2024

Primary outcome: Primary: Change in Mean Global Composite Cognition Score From Baseline — 0.2; 0.2 Z-score — p=0.259

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Multicultural Healthy Diet (Other); Usual Diet plus Self-Care (Other)
Age: Adult, Older Adult · 40+ yrs
Sex: All
Sponsor: Albert Einstein College of Medicine
Primary completion: Jul 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Mean Global Composite Cognition Score From Baseline	0.2; 0.2	0.259
SECONDARY Dietary Inflammatory Index (DII) Score	1.10; 1.17; 0.70; 1.38	0.001 sig
SECONDARY Energy-Adjusted DII Score	-0.30; -0.30; -0.98; -0.09	<0.001 sig
SECONDARY Total Serum Folate Levels	35.93; 34.72; 35.26; 35.01	0.904
SECONDARY α-Tocopherol Levels	11.39; 11.02; 11.45; 11.26	0.721
SECONDARY α-Carotenoid Levels	0.04; 0.04; 0.04; 0.04	0.769
SECONDARY Vitamin B12 Levels	736.78; 712.89; 718.23; 716.22	0.978
SECONDARY Fatty Acid Profile	10.76; 11.09; 10.91; 10.96; 2.14; 2.12	0.395
SECONDARY Serum Sodium	139.88; 139.89; 140.24; 140.11	0.521
SECONDARY Self-reported Diet Components and Food Groups: Total Moisture	1821; 1812; 1943; 1790	0.101
SECONDARY Self-reported Diet Components and Food Groups: Energy	1622.31; 1608.62; 1545.25; 1560.3	0.645
SECONDARY Self-reported Diet Components and Food Groups: Protein	73.92; 73.31; 73.42; 70.09	0.245
SECONDARY Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices	0.85; 0.77; 0.95; 0.68	0.032 sig
SECONDARY Self-reported Diet Components and Food Groups: Dark Green Vegetables	0.3; 0.33; 0.43; 0.28	<0.001 sig
SECONDARY Self-reported Diet Components and Food Groups: Total Fats	67.3; 66.71; 65.69; 66.77	0.635
SECONDARY Self-reported Diet Components and Food Groups: Solid Fats	26.84; 26.77; 23.14; 26.93	0.019 sig
SECONDARY Self-reported Diet Components and Food Groups: Carbohydrates	181.11; 176.49; 169.66; 169.23	0.639
SECONDARY Self-reported Diet Components and Food Groups: Total Folate From Food	199.05; 197.56; 224.17; 181.69	<0.001 sig
SECONDARY Self-reported Diet Components and Food Groups: Non-food Folate	125.15; 130.78; 109.97; 127.73	0.115
SECONDARY Self-reported Diet Components and Food Groups: Vitamin B-12	4.25; 4.21; 4.18; 4.06	0.847
SECONDARY Self-reported Diet Components and Food Groups: Alpha Carotene	568.66; 448.66; 586.56; 392.19	0.191
SECONDARY Self-reported Diet Components and Food Groups: Beta Carotene	3464.67; 3389.68; 4040.06; 2948.25	0.019 sig
SECONDARY Self-reported Diet Components and Food Groups: Retinol	327.45; 317.48; 302.99; 318.97	0.493
SECONDARY Self-reported Diet Components and Food Groups: Beta Cryptoxanthin	96.49; 57.57; 81.28; 57.41	0.18
SECONDARY Self-reported Diet Components and Food Groups: Lycopene	3905.68; 3558.21; 3685.28; 3244.35	0.379
SECONDARY Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin	2885.48; 2765.1; 3570.56; 2609.09	0.083
SECONDARY Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E)	7.48; 7.59; 8.69; 7.34	0.011 sig
SECONDARY Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids	0.58; 0.44; 0.56; 0.44	0.541
SECONDARY Self-reported Diet Components and Food Groups: EPA (P205)	0.07; 0.06; 0.07; 0.05	0.273
SECONDARY Self-reported Diet Components and Food Groups: DHA (P226)	0.14; 0.12; 0.13; 0.1	0.116
SECONDARY Self-reported Diet Components and Food Groups: DPA (P225)	0.03; 0.03; 0.03; 0.02	0.213
SECONDARY Self-reported Diet Components and Food Groups: Beans and Peas (Legumes)	0.12; 0.1; 0.14; 0.09	0.036 sig
SECONDARY Self-reported Diet Components and Food Groups: Whole Grains	0.75; 0.85; 1.06; 0.90	0.223
SECONDARY Self-reported Diet Components and Food Groups: Cured Meats	0.74; 0.64; 0.63; 0.76	0.119
SECONDARY Self-reported Diet Components and Food Groups: Poultry	1.82; 1.89; 1.79; 1.82	0.841
SECONDARY Self-reported Diet Components and Food Groups: Nuts and Seeds	0.57; 0.58; 0.82; 0.56	0.088
SECONDARY Self-reported Diet Components and Food Groups: Cheeses	0.58; 0.62; 0.51; 0.54	0.893
SECONDARY Self-reported Diet Components and Food Groups: Added Sugars	10.06; 9.91; 7.91; 9.31	0.042 sig
SECONDARY Symbol Search Task Performance	1,874.7; 1,846.4; 1,854.4; 1,800.5; 1,845.0; 1,825.6	0.031 sig
SECONDARY Grid Memory Task Performance	34.0; 35.2; 29.0; 30.4; 26.8; 31.6	0.55
SECONDARY Color Shapes Task Performance	0.6; 0.6; 0.6; 0.6; 0.6; 0.6	0.846

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03240406). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.