Multicultural Healthy Diet to Reduce Cognitive Decline

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.