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Criterion validation of nutrient profiling systems: a systematic review and meta-analysis.
Barrett, EM, Afrin, H, Rayner, M, Pettigrew, S, Gaines, A, Maganja, D, Jones, A, Mozaffarian, D, Beck, EJ, Neal, B, et al
The American journal of clinical nutrition. 2024;(1):145-163
Abstract
BACKGROUND Nutrient profiling systems (NPSs) use algorithms to evaluate the nutritional quality of foods and beverages. Criterion validation, which assesses the relationship between consuming foods rated as healthier by the NPS and objective measures of health, is essential to ensure the accuracy of NPSs. OBJECTIVE We examined and compared NPSs that have undergone criterion validity testing in relation to diet-related disease risk and risk markers. METHODS Academic databases were searched for prospective cohort and cross-sectional studies published before November, 2022. NPSs were eligible if they incorporated multiple nutrients or food components using an algorithm to determine an overall summary indicator (e.g., a score or rank) for individual foods. Studies were included if they assessed the criterion validity of an eligible NPS. Validation evidence was first summarized in narrative form by NPS, with random effects meta-analysis where ≥2 prospective cohort studies assessed the same NPS and outcomes. RESULTS Of 4519 publications identified, 29 describing 9 NPSs were included in the review. The Nutri-Score NPS was assessed as having substantial criterion validation evidence. Highest compared with lowest diet quality as defined by the Nutri-Score was associated with significantly lower risk of cardiovascular disease (hazard ratio [HR]: 0.74; 95% confidence interval [CI]: 0.59, 0.93; n = 6), cancer (HR: 0.75; 95% CI: 0.59, 0.94; n = 5), all-cause mortality (HR: 0.74; 95% CI; 0.59, 0.91; n = 4) and change in body mass index (HR: 0.68; 95% CI: 0.50, 0.92; n = 3). The Food Standards Agency NPS, Health Star Rating, Nutrient Profiling Scoring Criterion, Food Compass, Overall Nutrition Quality Index, and the Nutrient-Rich Food Index were determined as having intermediate criterion validation evidence. Two other NPSs were determined as having limited criterion validation evidence. CONCLUSIONS We found limited criterion validation studies compared with the number of NPSs estimated to exist. Greater emphasis on conducting and reporting on criterion validation studies across varied contexts may improve the confidence in existing NPSs.
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"Food Is Medicine" Strategies for Nutrition Security and Cardiometabolic Health Equity: JACC State-of-the-Art Review.
Mozaffarian, D, Aspry, KE, Garfield, K, Kris-Etherton, P, Seligman, H, Velarde, GP, Williams, K, Yang, E, ,
Journal of the American College of Cardiology. 2024;(8):843-864
Abstract
"Food Is Medicine" (FIM) represents a spectrum of food-based interventions integrated into health care for patients with specific health conditions and often social needs. Programs include medically tailored meals, groceries, and produce prescriptions, with varying levels of nutrition and culinary education. Supportive advances include expanded care pathways and payment models, e-screening for food and nutrition security, and curricular and accreditation requirements for medical nutrition education. Evidence supports positive effects of FIM on food insecurity, diet quality, glucose control, hypertension, body weight, disease self-management, self-perceived physical and mental health, and cost-effectiveness or cost savings. However, most studies to date are quasiexperimental or pre/post interventions; larger randomized trials are ongoing. New national and local programs and policies are rapidly accelerating FIM within health care. Remaining research gaps require rigorous, iterative evaluation. Successful incorporation of FIM into health care will require multiparty partnerships to assess, optimize, and scale these promising treatments to advance health and health equity.
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The Gut Microbial Metabolite Trimethylamine N-oxide, Incident CKD, and Kidney Function Decline.
Wang, M, Tang, WHW, Li, XS, de Oliveira Otto, MC, Lee, Y, Lemaitre, RN, Fretts, A, Nemet, I, Sotoodehnia, N, Sitlani, CM, et al
Journal of the American Society of Nephrology : JASN. 2024
Abstract
BACKGROUND Trimethylamine N-oxide (TMAO) is a gut microbiota-derived metabolite of dietary phosphatidylcholine and carnitine. Experimentally, TMAO causes kidney injury and tubulointerstitial fibrosis. Little is known about prospective associations between TMAO and kidney outcomes, especially incident CKD. We hypothesized that higher plasma TMAO levels would be associated with higher risk of incident CKD and greater rate of kidney function decline. METHODS We included 10,564 participants from two community-based, prospective cohorts with estimated glomerular filtration rate (eGFR) ≥ 60 mL/min/1.73m2 to assess incident CKD. TMAO was measured using targeted mass spectrometry at baseline and one follow-up visit. Creatinine and Cystatin C were measured up to 4 times during follow-up and used to compute eGFR. Incident CKD was defined as an eGFR decline ≥ 30% from baseline and a resulting eGFR<60 ml/min/1.73 m2. Time-varying Cox models assessed the association of serial TMAO measures with incident CKD, adjusting for sociodemographic, lifestyle, diet, and cardiovascular disease risk factors. Linear mixed models assessed the association with annualized eGFR change in 10,009 participants with at least one follow-up eGFR measure without exclusions for baseline eGFR levels. RESULTS During a median follow-up of 9.4 years (interquartile range: 9.1-11.6 years), 979 incident CKD events occurred. Higher TMAO levels associated with higher risk of incident CKD (2nd to 5th vs. 1st quintile HR[95%CI]= 1.65 [1.22-2.23], 1.68 [1.26-2.25], 2.28 [1.72-3.02], and 2.24[1.68-2.98], respectively) and greater annualized eGFR decline ( 2nd to 5th vs. 1st quintile annualized eGFR change= -0.21 [-0.32, -0.09], -0.17 [-0.29, -0.05], -0.35 [-0.47, -0.22], and -0.43[-0.56, -0.30], respectively) with monotonic dose-response relationships. These associations were consistent across different racial/ethnic groups examined. The association with eGFR decline was similar to or larger than that seen for established CKD risk factors including diabetes, per 10 mmHg of higher systolic blood pressure, per 10 years of older age, and Black race. CONCLUSIONS In community-based US adults, higher serial measures of plasma TMAO were associated with higher risk of incident CKD and greater annualized kidney function decline.
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Diet and Food and Nutrition Insecurity and Cardiometabolic Disease.
Brandt, EJ, Mozaffarian, D, Leung, CW, Berkowitz, SA, Murthy, VL
Circulation research. 2023;(12):1692-1706
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Abstract
Poor nutrition is the leading cause of poor health, health care spending, and lost productivity in the United States and globally, which acts through cardiometabolic diseases as precursors to cardiovascular disease, cancer, and other conditions. There is great interest in how the social determinants of health (the conditions in which people are born, live, work, develop, and age) impact cardiometabolic disease. Food insecurity is an example of a powerful social determinant of health that impacts health outcomes. Nutrition insecurity, a distinct but related concept to food insecurity, is a direct determinant of health. In this article, we provide an overview of how diet in early life relates to cardiometabolic disease and then continue to focus on the concepts of food insecurity and nutrition insecurity. In the discussions herein we make important distinctions between the concepts of food insecurity and nutrition insecurity and provide a review of their concepts, histories, measurement and assessment devices, trends and prevalence, and links to health and health disparities. The discussions here set the stage for future research and practice to directly address the negative consequences of food and nutrition insecurity.
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Plasma Trimethylamine-N-Oxide and Incident Ischemic Stroke: The Cardiovascular Health Study and the Multi-Ethnic Study of Atherosclerosis.
Lemaitre, RN, Jensen, PN, Wang, Z, Fretts, AM, Sitlani, CM, Nemet, I, Sotoodehnia, N, de Oliveira Otto, MC, Zhu, W, Budoff, M, et al
Journal of the American Heart Association. 2023;(16):e8711
Abstract
Background The association of circulating trimethylamine-N-oxide (TMAO) with stroke has received limited attention. To address this gap, we examined the associations of serial measures of plasma TMAO with incident ischemic stroke. Methods and Results We used a prospective cohort design with data pooled from 2 cohorts. The settings were the CHS (Cardiovascular Health Study), a cohort of older adults, and the MESA (Multi-Ethnic Study of Atherosclerosis), both in the United States. We measured plasma concentrations of TMAO at baseline and again during the follow-up using high-performance liquid chromatography and mass spectrometry. We assessed the association of plasma TMAO with incident ischemic stroke using proportional hazards regression adjusted for risk factors. The combined cohorts included 11 785 participants without a history of stroke, on average 73 (CHS) and 62 (MESA) years old at baseline, including 60% (CHS) and 53% (MESA) women. We identified 1031 total incident ischemic strokes during a median 15-year follow-up in the combined cohorts. In multivariable analyses, TMAO was significantly associated with incident ischemic stroke risk (hazard ratios comparing a doubling of TMAO 1.11 [1.03-1.18], P=0.004). The association was linear over the range of TMAO concentrations and appeared restricted to those without diagnosed coronary heart disease. An association with hemorrhagic stroke was not found. Conclusions Plasma TMAO levels are associated with incident ischemic stroke in a diverse population. Registration URL: https://www.clinicaltrials.gov. Unique identifier: NCT00005133.
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Association of omega 3 polyunsaturated fatty acids with incident chronic kidney disease: pooled analysis of 19 cohorts.
Ong, KL, Marklund, M, Huang, L, Rye, KA, Hui, N, Pan, XF, Rebholz, CM, Kim, H, Steffen, LM, van Westing, AC, et al
BMJ (Clinical research ed.). 2023;:e072909
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Abstract
OBJECTIVE To assess the prospective associations of circulating levels of omega 3 polyunsaturated fatty acid (n-3 PUFA) biomarkers (including plant derived α linolenic acid and seafood derived eicosapentaenoic acid, docosapentaenoic acid, and docosahexaenoic acid) with incident chronic kidney disease (CKD). DESIGN Pooled analysis. DATA SOURCES A consortium of 19 studies from 12 countries identified up to May 2020. STUDY SELECTION Prospective studies with measured n-3 PUFA biomarker data and incident CKD based on estimated glomerular filtration rate. DATA EXTRACTION AND SYNTHESIS Each participating cohort conducted de novo analysis with prespecified and consistent exposures, outcomes, covariates, and models. The results were pooled across cohorts using inverse variance weighted meta-analysis. MAIN OUTCOME MEASURES Primary outcome of incident CKD was defined as new onset estimated glomerular filtration rate <60 mL/min/1.73 m2. In a sensitivity analysis, incident CKD was defined as new onset estimated glomerular filtration rate <60 mL/min/1.73 m2 and <75% of baseline rate. RESULTS 25 570 participants were included in the primary outcome analysis and 4944 (19.3%) developed incident CKD during follow-up (weighted median 11.3 years). In multivariable adjusted models, higher levels of total seafood n-3 PUFAs were associated with a lower incident CKD risk (relative risk per interquintile range 0.92, 95% confidence interval 0.86 to 0.98; P=0.009, I2=9.9%). In categorical analyses, participants with total seafood n-3 PUFA level in the highest fifth had 13% lower risk of incident CKD compared with those in the lowest fifth (0.87, 0.80 to 0.96; P=0.005, I2=0.0%). Plant derived α linolenic acid levels were not associated with incident CKD (1.00, 0.94 to 1.06; P=0.94, I2=5.8%). Similar results were obtained in the sensitivity analysis. The association appeared consistent across subgroups by age (≥60 v <60 years), estimated glomerular filtration rate (60-89 v ≥90 mL/min/1.73 m2), hypertension, diabetes, and coronary heart disease at baseline. CONCLUSIONS Higher seafood derived n-3 PUFA levels were associated with lower risk of incident CKD, although this association was not found for plant derived n-3 PUFAs. These results support a favourable role for seafood derived n-3 PUFAs in preventing CKD.
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n-6 fatty acid biomarkers and incident atrial fibrillation: an individual participant-level pooled analysis of 11 international prospective studies.
Garg, PK, Guan, W, Nomura, S, Weir, NL, Tintle, N, Virtanen, JK, Hirakawa, Y, Qian, F, Sun, Q, Rimm, E, et al
The American journal of clinical nutrition. 2023;(5):921-929
Abstract
BACKGROUND The presence of atrial fibrillation (AF) is associated with an over 2-fold increased risk of stroke, heart failure, and cardiovascular mortality. Long chain n-6 PUFAs have been suggested to have a variety of beneficial biologic effects that may reduce AF development; however, prior studies evaluating this relationship are limited. OBJECTIVES We prospectively evaluated the association between circulating levels of linoleic acid (LA) and arachidonic acid (AA) with incident AF. METHODS We used participant-level data from a global consortium of 11 prospective cohort studies with measurements of LA and AA in adults (aged ≥18 y). Participating studies conducted de novo analyses using a prespecified analytical plan with harmonized definitions for exposures, outcomes, covariates, and subgroups. Associations were pooled using inverse-variance weighted meta-analysis. RESULTS Among 41,335 participants, 6173 incident cases of AF were ascertained, with median follow-up time of 14 y. In multivariable analysis, per interquintile range (difference between the 10th and 90th percentiles for each fatty acid), circulating n-6 levels were not associated with incident AF. For LA, the hazard ratio per interquintile range was 0.96 (95% confidence interval [CI]: 0.89, 1.04), and for AA, 1.02 (95% CI: 0.94, 1.10), with little evidence of heterogeneity between cohorts. Associations were similarly nonsignificant across subgroups of age, race, and biomarker fraction. CONCLUSIONS Biomarkers of n-6 fatty acids including LA and AA are not associated with incident AF. These findings suggest that overall effects of n-6 PUFAs on influencing AF development are neutral.
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Effect of a Nutrition Intervention on Mediterranean Diet Adherence Among Firefighters: A Cluster Randomized Clinical Trial.
Hershey, MS, Chang, CR, Sotos-Prieto, M, Fernandez-Montero, A, Cash, SB, Christophi, CA, Folta, SC, Muegge, C, Kleinschmidt, V, Moffatt, S, et al
JAMA network open. 2023;(8):e2329147
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IMPORTANCE US firefighters are a working population at risk of chronic diseases, including obesity, cardiovascular disease, and cancer. This risk may be mitigated by a healthy diet. OBJECTIVE To evaluate the effect of a Mediterranean nutrition intervention using a behavioral/environmental approach (firefighter/fire station/home) at the individual participant level. DESIGN, SETTING, AND PARTICIPANTS This 12-month cluster randomized clinical trial included US career firefighters from fire stations and homes within 2 Indiana fire departments. Participants were randomized by fire station to either Mediterranean diet or control (usual care). The study was conducted from October 2016 to December 2019, and data were analyzed in November 2022. INTERVENTION For the first 12 months of the study, firefighters located at fire stations randomized to the intervention group were provided with access to supermarket discounts and free samples of Mediterranean diet foods, online nutrition education platforms, email announcements and reminders, family and peer education and support, and chef demonstrations. Firefighters in fire stations allocated to the control group received no intervention and were instructed to follow their usual diet. MAIN OUTCOMES AND MEASURES Change in dietary habits at 12 months as measured by a modified Mediterranean diet score (range, 0 to 51 points) at baseline and 6-month and 12-month follow-up. Cardiometabolic parameters were secondary outcomes. RESULTS Of 485 included firefighters, 458 (94.4%) were male, and the mean (SD) age was 47 (7.5) years. A total of 241 firefighters (27 fire stations) were randomized to the Mediterranean nutrition intervention, and 244 (25 fire stations) were randomized to usual diet. Outcomes were analyzed using generalized linear mixed models for modified Mediterranean diet score at 6 months (n = 336) and 12 months (n = 260), adjusting for baseline age, sex, race and ethnicity, fire department, physical activity, and waist circumference. In the intervention group compared with the control group, the modified Mediterranean diet score significantly increased by 2.01 points (95% CI, 0.62-3.40; P = .005) at 6 months and by 2.67 points (95% CI, 1.14-4.20; P = .001) at 12 months. Among secondary outcomes, changes in cardiometabolic risk factors were not statistically significant at 1 year. Results from analyses with multilevel multiple imputation for missingness were similar. CONCLUSIONS AND RELEVANCE In this Mediterranean nutrition intervention of multicomponent behavioral/environmental changes, career firefighters had increased adherence to a Mediterranean diet. TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT02941757.
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Nicotinamide riboside and pterostilbene reduces markers of hepatic inflammation in NAFLD: A double-blind, placebo-controlled clinical trial.
Dellinger, RW, Holmes, HE, Hu-Seliger, T, Butt, RW, Harrison, SA, Mozaffarian, D, Chen, O, Guarente, L
Hepatology (Baltimore, Md.). 2023;(3):863-877
Abstract
BACKGROUND AND AIMS The prevalence of NAFLD is increasing globally and on a path to becoming the most frequent cause of chronic liver disease. Strategies for the prevention and treatment of NAFLD are urgently needed. APPROACH AND RESULTS A 6-month prospective, randomized, double-blind, placebo-controlled clinical trial was conducted to assess the efficacy of daily NRPT (commercially known as Basis, a combination of nicotinamide riboside and pterostilbene) supplementation in 111 adults with NAFLD. The study consisted of three arms: placebo, recommended daily dose of NRPT (NRPT 1×), and a double dose of NRPT (NRPT 2×). NRPT appeared safe and well tolerated. At the end of the study, no significant change was seen in the primary endpoint of hepatic fat fraction with respect to placebo. However, among prespecified secondary outcomes, a time-dependent decrease in the circulating levels of the liver enzymes alanine aminotransferase (ALT) and gamma-glutamyltransferase (GGT) was observed in the NRPT 1× group, and this decrease was significant with respect to placebo. Furthermore, a significant decrease in the circulating levels of the toxic lipid ceramide 14:0 was also observed in the NRPT 1× group versus placebo, and this decrease was associated with a decrease in ALT in individuals of this group. A dose-dependent effect was not observed with respect to ALT, GGT, or ceramide 14:0 in the NRPT 2× group. CONCLUSIONS This study demonstrates that NRPT at the recommended dose is safe and may hold promise in lowering markers of hepatic inflammation in patients with NAFLD.
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Protocol for a randomized controlled trial of medically tailored meals compared to usual care among individuals with type 2 diabetes in Australia.
Law, KK, Coyle, DH, Neal, B, Huang, L, Barrett, EM, Arnott, C, Chow, CK, Di Tanna, GL, Lung, T, Mozaffarian, D, et al
Contemporary clinical trials. 2023;:107307
Abstract
BACKGROUND 'Food is medicine' strategies aim to integrate food-based nutrition interventions into healthcare systems and are of growing interest to healthcare providers and policy makers. 'Medically Tailored Meals' (MTM) is one such intervention, which involves the 'prescription' by healthcare providers of subsidized, pre-prepared meals for individuals to prevent or manage chronic conditions, combined with nutrition education. OBJECTIVE This study will test the efficacy of an MTM program in Australia among participants with type 2 diabetes (T2D) and hyperglycemia, who experience difficulties accessing and eating nutritious food. METHODS This study will be a two-arm parallel trial (goal n = 212) with individuals randomized in a 1:1 ratio to a MTM intervention group or a control group (106 per arm). Over 26 weeks, the intervention group will be prescribed 20 MTM per fortnight and up to 3 sessions with an accredited dietitian. Controls will continue with their usual care. The primary outcome is glycated hemoglobin (HbA1c, %) and secondary outcomes include differences in blood pressure, blood lipids and weight, all measured at 26 weeks. Process and economic data will be analyzed to assess the feasibility, acceptability, scalability, and cost-effectiveness of the intervention. Recruitment commenced in the first quarter of 2023, with analyses and results anticipated to be available by March 2025. DISCUSSION Few randomized controlled trials have assessed the impact of MTM on clinical outcomes. This Australian-first trial will generate robust data to inform the case for sustained, large-scale implementation of MTM to improve the management of T2D among vulnerable populations. ANZCTR ACTRN12622000852752. PROTOCOL VERSION Version 1.1, July 2023.