Multicultural Healthy Diet to Reduce Cognitive Decline (MHD)

December 10, 2024 updated by: Yasmin Mossavar-Rahmani, Albert Einstein College of Medicine

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
393

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Albert Einstein College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Mean Global Composite Cognition Score From Baseline
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Change in global composite cognition score (standardized unit) is computed as the average of the three domain-specific Z-scores of the participant's performance on three ambulatory cognitive assessments: visuospatial working memory (Dot Grid Memory), processing speed (Symbol Search), and short-term associative memory binding (Color Shapes Task) at 9 months post baseline (Burst 1). Z-scores are centered at a population mean of "0" (i.e., a Z-score of "0" signifies that the data point(s) is equal to the population mean at study baseline for all three tasks in the composite average; positive Z-score group values indicate the number of standard deviations the data point(s) is above the mean and negative Z-score group values indicate the number of standard deviations the data point(s) is below the mean). Mean change in global composite Z-score from baseline will be reported by study arm. Increase in composite Z-scores from baseline are associated with improved cognition.
Baseline (Burst 1) and 9 months (Burst 2)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Dietary Inflammatory Index (DII) Score
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
DII score was determined by an algorithm that summarized the inflammatory potential of the diet. The DII score represents a weighted sum of the self-reported quantities of 28 foods, each translated into Z-scores using a global comparative database consisting of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the standard deviation (SD). Z-scores are centered at a population mean of "0" (i.e., a Z-score of "0" signifies that the data point(s) is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point(s) is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher Z-score values are indicative of a more pro-inflammatory diet.
Baseline (Burst 1) and 9 months (Burst 2)
Energy-Adjusted DII Score
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Energy-adjusted DII score was determined by an algorithm that summarized the inflammatory potential of the diet. This score represents a weighted sum of self-reported quantities of 28 foods per 1000 kilocalories of consumption that were then translated into Z-scores using a global comparative database of data from 11 countries by subtracting from the individual's self-report value the mean of the global database, then dividing by the SD. Z-scores are centered at a population mean of 0 (i.e., a Z-score of 0 signifies that the data point is = to the population mean at study baseline for all 3 tasks in the composite average; positive and negative Z-score group values indicate the number of SD the data point is above or below the mean, respectively). For this study, possible scoring range for 28 food parameters was -8 to 8 based on ref: Hebert JR, et.al., Perspective: The Dietary Inflammatory Index (DII®): Adv Nutr. 2019;10:185-95. Higher values are indicative of a more inflammatory diet.
Baseline (Burst 1) and 9 months (Burst 2)
Total Serum Folate Levels
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota Advanced Research & Diagnostic Laboratory (ARDL) for total folate analysis by a validated serum folate assay. Mean total folate levels are summarized by study arm and reported in nmol/L. The lower limit of detection (LLOD) for mean total folate is 4.54 nmol/L and the upper limit of detection (ULOD) 90.8 nmol/L. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern such as eating more green leafy vegetables.
Baseline (Burst 1) and 9 months (Burst 2)
α-Tocopherol Levels
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL for α-tocopherol analysis by an HPLC method. α-Tocopherols were measured with a diode array detector equipped HPLC system. Mean α-tocopherol levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker from this laboratory (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.
Baseline (Burst 1) and 9 months (Burst 2)
α-Carotenoid Levels
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Blood plasma specimens were collected and processed at Baseline and 9-months post-intervention from a sub-sample and shipped to University of Minnesota ARDL lab for α-carotenoid analysis by an HPLC method. α-Carotenoids were measured with a diode array detector equipped HPLC system. Mean α-carotenoid levels are summarized by study arm and reported in mcg/mL. There are no reference ranges for this biomarker (other than non-negative values). Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.
Baseline (Burst 1) and 9 months (Burst 2)
Vitamin B12 Levels
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Blood sera specimens were collected and processed at Baseline and 9-months post-intervention and shipped to University of Minnesota ARDL laboratory for Vitamin B12 analysis by a validated Vitamin B12 assay. Mean Vitamin B12 levels are summarized by study arm and reported in pg/mL. Reference ranges for this biomarker are: 232-1245 pg/mL and LLOD is 100 pg/mL. Increase in this biomarker from baseline for MHD participants indicates possible adherence to an MHD dietary pattern.
Baseline (Burst 1) and 9 months (Burst 2)
Fatty Acid Profile
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)

Blood plasma specimens were collected and processed at Baseline and 9-months follow-up for a sub-sample and shipped to University of Minnesota ARDL laboratory for total fatty acid analysis by a gas chromatography method. Fatty acids are expressed as a percent of total fatty acids. Fatty acids are compared with each sample rather than measured against a standard and the range of percentage values for each fatty acid is 0-100%. Mean percentage plasma levels of the following fatty acids will be summarized by study arm for Burst 2: Sum of monounsaturated fatty acids (n=6); Long chain saturated fatty acids (fatty acids with 20 or more carbons (n=3)); EPA (eicosapentaenoic acid); DHA (docosahexaenoic acid); n3 DPA (omega three docosapentaenoic acid).

Monounsaturated fat is a composite of 6 fatty acids: 16:1n7 cis, 17:1n7T, 18:1n9 cis,18:1n7 cis, 20:1n9, and 24:1n9 Long chain saturated fat is a composite of 3 fatty acids: 22:0, 23:0, and 24:0
Baseline (Burst 1) and 9 months (Burst 2)
Serum Sodium
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Serum specimens were collected and processed at Baseline and 9-months follow-up and shipped to University of Minnesota ARDL laboratory for analysis on Roche Cobas 8000 Chemistry Analyzer. Mean serum sodium levels are summarized by study arm and reported in mmol/L. Reference range is 136-145 mmol/L and the lower LOD is 80 mmol/L. Decreased serum sodium levels from baseline may indicate dehydration.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Total Moisture
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Total Moisture obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total moisture from diet was captured by the MOIS variable field within the ASA24. This field is quantified in grams (g) of water. Possible results values are limited to values > 0 (i.e., positive values). Basic descriptive statistics were used to summarize data by arm.ASA-2018 and 2020
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Energy
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Energy obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total energy from diet was captured by the KCAL variable field within the ASA24. This field represents kilocalories (kcal) of energy. Possible results values are to values > 500kcal. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Protein
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Protein obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Protein from the diet was captured by the PROT variable field within the ASA24. This field represents grams (g) of protein consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Total Intact Fruits + Fruit Juices
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Total Intact fruits and fruit juices obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Intact fruit and fruit juice consumption from the diet was captured by the F_TOTAL variable field within the ASA24. This field represents total fruit consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Dark Green Vegetables
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Dark Green Vegetables obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Dark green vegetable consumption from the diet was captured by the V_DRKGR variable field within the ASA24. This field represents dark green vegetable consumption in cup equivalents (cup eq). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Total Fats
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Total fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total fats from the diet, which consisted of total saturated fatty acids, total monounsaturated fatty acids, and total polyunsaturated fatty acids, was captured by the TFAT variable field within the ASA24. This field represents grams (g) of total fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Solid Fats
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Solid fats obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Solid fats from the diet was captured by the DISCFAT_SOL variable field within the ASA24. This field represents grams (g) of solid fats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Carbohydrates
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Carbohydrates obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Carbohydrates from the diet was captured by the CARB variable field within the ASA24. This field represents grams (g) of carbohydrates consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Total Folate From Food
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Total Folate from food obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Total Folate from food was captured by the FF variable field within the ASA24. This field represents micrograms (mcg) of total folate from food consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Non-food Folate
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Non-food Folate obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Non-food Folate was captured by the FDFE variable field within the ASA24. This field represents micrograms (mcg) of Non-food Folate consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Vitamin B-12
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Vitamin B-12 obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Vitamin B-12 was captured by the VB12 variable field within the ASA24. This field represents micrograms (mcg) of Vitamin B-12 consumed (including supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Alpha Carotene
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Alpha Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Carotene from the diet was captured by the ACAR variable field within the ASA24. This field represents micrograms (mcg) of Alpha Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Beta Carotene
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Beta Carotene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Carotene from the diet was captured by the BCAR variable field within the ASA24. This field represents micrograms (mcg) of Beta Carotene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Retinol
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Retinol obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Retinol from the diet was captured by the RET variable field within the ASA24. This field represents micrograms (mcg) of Retinol consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Beta Cryptoxanthin
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Beta Cryptoxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Beta Cryptoxanthin from the diet was captured by the CRYP variable field within the ASA24. This field represents micrograms (mcg) of Beta Cryptoxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Lycopene
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Lycopene obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lycopene from the diet was captured by the LYCO variable field within the ASA24. This field represents micrograms (mcg) of Lycopene consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Lutein + Zeaxanthin
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Lutein + Zeaxanthin obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Lutein + Zeaxanthin from the diet was captured by the LZ variable field within the ASA24. This field represents micrograms (mcg) of Lutein + Zeaxanthin consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Alpha Tocopherol (Vitamin E)
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Alpha Tocopherol (Vitamin E) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Alpha Tocopherol from the diet was captured by the ATOC variable field within the ASA24. This field represents micrograms (mg) of Alpha Tocopherol consumed (including from supplemental sources). Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Seafood High in n-3 Fatty Acids
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Seafood high in n-3 fatty acids obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Seafood high in n-3 fatty acids from the diet was captured by the M_FISH_HI variable field within the ASA24. This field represents ounce equivalents (oz eq) of Seafood high in n-3 fatty acids consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: EPA (P205)
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
EPA (P205) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. EPA (P205) from the diet was captured by the P205 variable field within the ASA24. This field represents grams (g) of EPA (P205) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: DHA (P226)
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
DHA (P226) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DHA (P226) from the diet was captured by the P226 variable field within the ASA24. This field represents grams (g) of DHA (P226) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: DPA (P225)
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
DPA (P225) obtained from the participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. DPA (P225) from the diet was captured by the P225 variable field within the ASA24. This field represents grams (g) of DPA (P225) consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Beans and Peas (Legumes)
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Beans and peas (Legumes) consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Legumes information from the diet was captured by the V_LEGUMES variable field within the ASA24. This field represents cup equivalents (cup eq) of legumes consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Whole Grains
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Whole grains consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Whole grains information from the diet was captured by the G_WHOLE variable field within the ASA24. This field represents ounce equivalents (oz eq) of whole grains consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Cured Meats
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Cured meats consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cured meats information from the diet was captured by the PF_CUREDMEAT variable field within the ASA24. This field represents ounce equivalents (oz eq) of cured meats consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Poultry
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Poultry consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Poultry information from the diet was captured by the PF_POULT variable field within the ASA24. This field represents ounce equivalents (oz eq) of poultry consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Nuts and Seeds
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Nuts and seeds consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Nuts and seeds information from the diet was captured by the PF_NUTSDS variable field within the ASA24. This field represents ounce equivalents (oz eq) of nuts and seeds consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Cheeses
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Cheeses consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Cheese information from the diet was captured by the D_CHEESE variable field within the ASA24. This field represents cup equivalents (cup eq) of cheeses consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Self-reported Diet Components and Food Groups: Added Sugars
Time Frame: Baseline (Burst 1) and 9 months (Burst 2)
Added sugars consumed as part of participants' diet was derived as a parameter of the self-reported diet components and food groups from the 2018 and 2020 versions of the Automated Self-reported Self-administered 24 hour food records (ASA24-2018 and ASA24-2020) at baseline and 9 month follow-up. Added sugars information from the diet was captured by the ADD_SUGARS variable field within the ASA24. This field represents tablespoon equivalents (tsp eq) of added sugars consumed. Possible results values are limited to non-negative values. Basic descriptive statistics were used to summarize data by arm.
Baseline (Burst 1) and 9 months (Burst 2)
Symbol Search Task Performance
Time Frame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Symbol Search Task Performance is an ambulatory cognitive assessment of processing speed/attention. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). Mean response time in milliseconds (ms) for accurate trials will be determined and reported. Possible values ranges for Symbol Search Task Performance are >0 ms (i.e., positive values). Lower Symbol Search Task Performance values in mean response time are indicative of improvement in cognitive processing.
Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Grid Memory Task Performance
Time Frame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Grid Memory Task Performance is an ambulatory cognitive assessment of visuospatial working memory. The task is administered 5 times daily throughout each 7-day measurement Burst (Baseline, 9 months, 18 months, 27 months). The mean error distance (pixel Euclidean distance, represented in pixels) of the red dots between study and recall arrays will be quantified and reported based on the completion of 4 trials. Possible value ranges for pixels are >0 (i.e., positive values). Lower pixel values are indicative of improved short-term recall and visuospatial working memory.
Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Color Shapes Task Performance
Time Frame: Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention
Color Shapes Task Performance is an ambulatory cognitive assessment of short-term associative visual memory. The task is administered 5 times daily throughout each 7-day measurement Burst. The task had 2 conditions, signal present and signal absent. Hit rate represents the proportion of trials where participants correctly responded that signal was present. False alarm rate represents the proportion of trials where a signal was absent where participants incorrectly responded that a signal was present. Corrected Recognition Score represents the overall sensitivity to the signal and is calculated by subtracting the False alarm rate from the Hit rate and is summarized by study arm as described in Hakun, et.al., (2024). Mobile Monitoring of Cognitive Change (M2C2): High-Frequency Assessments and Protocol Reporting Guidelines. Possible ranges for Corrected Recognition Score are -1 to 1. Higher Corrected Recognition Rate values are indicative of better short term associative memory-binding.
Baseline (Burst 1), and 9 months (Burst 2), 18 months (Burst 3), and 27 months (Burst 4) post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Albert Einstein College of Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute on Aging (NIA)
University of Minnesota
Penn State University
Kaiser Permanente
National Center for Advancing Translational Sciences (NCATS)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yasmin Mossavar-Rahmani, Ph.D, RD, Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 3, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 1, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 4, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 12, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2016-6613
  • R01AG055527 (U.S. NIH Grant/Contract)
  • UL1TR002556 (U.S. NIH Grant/Contract)
  • K99AG056670 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines

IPD Sharing Time Frame

Reasonable time after completion of data analysis and key manuscripts

IPD Sharing Access Criteria

Data and specimens will be shared with potential collaborators, after obtaining participant consent, consistent with HIPPA guidelines.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Dietary Supplements

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