Abstract 10: Serum Metabolomic Signatures of Multiple Healthful Dietary Patterns and Incident Cardiometabolic Diseases in US Hispanics/Latinos

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Guochong Chen ◽  
Jin Choul Chai ◽  
Zhilei Shan ◽  
Bing Yu ◽  
Yasmin Mossavar-Rahmani ◽  
...  
Keyword(s):  
Dietary Patterns ◽  
Dietary Pattern ◽  
Healthy Eating Index ◽  
Health Study ◽  
Cardiometabolic Diseases ◽  
Dietary Index ◽  
Hispanic Community ◽  
Adult Participants ◽  
Underlying Mechanisms ◽  
Dietary Score

Introduction: Healthful dietary patterns are associated with lower cardiometabolic risk, but the underlying mechanisms are not fully understood. Hypothesis: Healthful dietary patterns share widespread metabolomic signatures that are associated with altered risk of cardiometabolic diseases. Methods: We analyzed data from 2976 adult participants free of diabetes and CVD in the Hispanic Community Health Study/Study of Latinos. Scores of three USDA recommended dietary patterns, Healthy Eating Index (HEI)-2015, alternative Mediterranean diet (aMED), and healthful plant-based dietary index (hPDI) were calculated by averaging two 24-hour dietary recalls. Fasting serum metabolomics was performed using an untargeted approach. Dietary pattern associated metabolite modules were clustered using a weighted correlation network analysis, and their associations with 6-year incidence of diabetes and hypertension were further examined. Results: Of 624 known metabolites identified, some were uniquely associated with a single dietary score, while 51 metabolites were significantly associated with all dietary scores ( Figure A ). Eight metabolite modules were clustered based on 184 dietary pattern-related metabolites. Each dietary score was associated with one unique metabolite module, and two modules composed of antioxidants or polyunsaturated fatty acids (PUFA) were associated with all dietary scores ( Figure B ). After multivariable adjustment for demographics, socioeconomics, lifestyles, and BMI, the antioxidant module was significantly associated with lower risk of diabetes (per SD, relative risk (RR) = 0.80 [95% CI 0.69-0.96]) and risk of hypertension (per SD, RR= 0.85 [0.73-0.99]), whereas the PUFA module was not associated with either outcome. Conclusions: Metabolomic signatures positively relating to three common healthful dietary patterns are found to be associated with lower incident cardiometabolic diseases, providing some mechanistic insights into the cardioprotection of high-quality diets.

scholarly journals Association between Dietary Inflammatory Index, Dietary Patterns, Plant-Based Dietary Index and the Risk of Obesity

Nutrients ◽  
2021 ◽  
Vol 13 (5) ◽  
pp. 1536
Author(s):  
Yoko B. Wang ◽  
Nitin Shivappa ◽  
James R. Hébert ◽  
Amanda J. Page ◽  
Tiffany K. Gill ◽  
...  
Keyword(s):  
Dietary Patterns ◽  
Dietary Pattern ◽  
Health Study ◽  
Healthy Plant ◽  
Dietary Inflammatory Index ◽  
Obesity Risk ◽  
North West ◽  
Inflammatory Index ◽  
Dietary Index ◽  
Increased Risk

Evidence on the association between various dietary constructs and obesity risk is limited. This study aims to investigate the longitudinal relationship between different diet indices and dietary patterns with the risk of obesity. Non-obese participants (n = 787) in the North West Adelaide Health Study were followed from 2010 to 2015. The dietary inflammatory index (DII®), plant-based dietary index (PDI) and factor-derived dietary pattern scores were computed based on food frequency questionnaire data. We found the incidence of obesity was 7.62% at the 5-year follow up. In the adjusted model, results from multivariable log-binomial logistic regression showed that a prudent dietary pattern (RRQ5 vs. Q1 = 0.38; 95% CI: 0.15–0.96), healthy PDI (RR = 0.31; 95% CI: 0.12–0.77) and overall PDI (RR = 0.56; 95% CI: 0.23–1.33) were inversely associated with obesity risk. Conversely, the DII (RR = 1.59; 95% CI: 0.72–3.50), a Western dietary pattern (RR = 2.16; 95% CI: 0.76–6.08) and unhealthy PDI (RR = 1.94; 95% CI: 0.81–4.66) were associated with increased risk of obesity. Based on the cubic spline analysis, the association between an unhealthy PDI or diet quality with the risk of obesity was non-linear. In conclusion, an anti-inflammatory diet, healthy diet or consumption of healthy plant-based foods were all associated with a lower risk of developing obesity.

Abstract P209: Sugar and Artificially-sweetened Beverages and 6-year Weight Change: Results From The Hispanic Community Health Study, Study of Latinos

Circulation ◽  
2020 ◽  
Vol 141 (Suppl_1) ◽  
Author(s):  
Samantha Schilsky ◽  
Wayne D Rosamond ◽  
June STEVENS ◽  
Carmen R Isasi ◽  
Martha L DAVIGLUS ◽  
...  
Keyword(s):  
Community Health ◽  
Daily Intake ◽  
Healthy Eating Index ◽  
Overweight And Obesity ◽  
Health Study ◽  
Sugar Intake ◽  
Sweetened Beverages ◽  
Hispanic Community ◽  
The Us ◽  
The U.S

Background: Sugar sweetened beverages (SSBs) are the largest contributor to added sugars and calories in the U.S. diet with highest intake among US Hispanics. The prevalence of obesity in adults in the US is much higher in Hispanics compared to non-Hispanic whites (47% and 38% respectively). Improving our understanding of the association between SSB and artificially sweetened beverage (ASB) consumption and measures of adiposity can inform interventions targeting overweight and obesity. Aim: Examine the independent associations of daily SSB and ASB consumption with 6-year changes in weight, waist circumference (WC) and body mass index (BMI) in Hispanics in the US. Methods: We examined 7402 adults without diabetes aged 18-74yrs at baseline (2008-11) from the Hispanic Community Health Study/Study of Latinos (HCHS/SOL), a multi-site community-based cohort in the US. Baseline exposures of daily SSB and ASB consumption were estimated combining two 24-hour dietary recalls and a Food Propensity Questionnaire using the NCI method to correct for measurement error and account for episodically consumed foods. Complex survey linear regression models were used to examine associations of SSBs and ASBs with 6-year change in weight (kg), WC (cm) and BMI. Models were adjusted for age, gender, center, background, education, employment, marital status, cigarette use, physical activity, healthy eating index, depressive symptoms, non-SSB sugar intake, years in the US and years between visits. Interactions of SSB and ASB with gender and years lived in the U.S. (US born, >10yr, ≤10 yr) were assessed. Results: Overall, 3326 [male=49.7%] and 1244 [male=35.7%] reported daily intake of >2 servings of SSBs and ASBs respectively whereas 2203 [male=26.1%] and 4318 [male=41.2%] reported daily intake < 1 servings of SSBs and ASBs respectively. Daily energy intake (kcal) was higher among those with higher daily SSB consumption [means=14768 and 2008 kcals; <1 serving and >2 servings, respectively] and lower with higher ASB consumption (means=1836 and 1773 kcals; <1 serving and >2 servings, respectively). Daily sugar intake independent of SSBs was higher with daily consumption of both SSB and ASB (<1 serving vs. 2 servings). Non-significant associations were found for daily SSB and ASB intake and changes in adiposity for all measures in males and females. Interaction between years in the U.S. and ASB consumption were significant only for change in weight and BMI [p<0.05]. Among those consuming <1 serving per day of ASBs, there was a larger mean change in weight and BMI for those who spent < 10yr in the U.S. compared to U.S. born. Conclusion: In this diverse Hispanic cohort, 6-year changes in measures of adiposity are not associated with daily SSB or ASB consumption. Modification of the association of ASB and measures of adiposity by years in US suggests further exploration is needed to discern its relationship among Hispanics.

scholarly journals Dietary Pattern and Risk of Multiple Myeloma in Two Large Prospective US Cohort Studies

2019 ◽  
Vol 3 (2) ◽  
Author(s):  
Dong Hoon Lee ◽  
Teresa T Fung ◽  
Fred K Tabung ◽  
Graham A Colditz ◽  
Irene M Ghobrial ◽  
...  
Keyword(s):  
Multiple Myeloma ◽  
Dietary Pattern ◽  
Association Studies ◽  
Positive Association ◽  
Healthy Eating Index ◽  
Health Study ◽  
Men Health ◽  
Cox Proportional Hazard Models ◽  
Inflammatory Pattern

AbstractBackgroundThe limited data on specific dietary components and risk of multiple myeloma (MM) show no consistent association. Studies have not examined the association of dietary pattern with MM risk.MethodsIn prospective cohorts of 69 751 women (Nurses’ Health Study, 1984–2014) and 47 232 men (Health Professionals Follow-up Study, 1986–2014), we examined the association between dietary pattern and risk of MM using Cox proportional hazard models. Diet was assessed repeatedly every 4 years with food frequency questionnaires and was used to calculate dietary patterns including the Alternate Healthy Eating Index-2010, Alternate Mediterranean Diet, Dietary Approaches to Stop Hypertension, Prudent and Western patterns, the empirical dietary inflammatory pattern (EDIP), and empirical dietary indices for insulin resistance (EDIR) and hyperinsulinemia (EDIH).ResultsDuring 2 792 257 person-years of follow-up, we identified 478 incident MM cases (215 women, 263 men). In men, high EDIP was statistically significantly associated with a 16% increase in MM risk (hazard ratio [HR] = 1.16, 95% confidence interval [CI] = 1.02 to 1.32 per 1-SD increase). Moreover, EDIR and EDIH had a suggestive positive association (EDIR: HR = 1.09, 95% CI = 0.96 to 1.24; and EDIH: HR = 1.11, 95% CI = 0.97 to 1.28 per 1-SD increase). We observed no other associations with MM risk in men and no associations for any dietary pattern with MM risk in women.ConclusionsWe present the first evidence for a role of diets with higher inflammatory or insulinemic potential in MM development. Further studies are warranted to explore these associations in other populations, including the apparent restriction to men.

scholarly journals Empirically Derived Dietary Patterns Using Robust Profile Clustering in the Hispanic Community Health Study/Study of Latinos

2020 ◽  
Vol 150 (10) ◽  
pp. 2825-2834
Author(s):  
Briana J K Stephenson ◽  
Daniela Sotres-Alvarez ◽  
Anna-Maria Siega-Riz ◽  
Yasmin Mossavar-Rahmani ◽  
Martha L Daviglus ◽  
...  
Keyword(s):  
United States ◽  
Community Health ◽  
Dietary Patterns ◽  
Latent Class ◽  
The United States ◽  
Ethnic Background ◽  
Latent Class Models ◽  
Nutrition Intervention ◽  
Health Study ◽  
Hispanic Community

ABSTRACT Background Latent class models (LCMs) have been used in exploring dietary behaviors over a wide set of foods and beverages in a given population, but are prone to overgeneralize these habits in the presence of variation by subpopulations. Objectives This study aimed to highlight unique dietary consumption differences by both study site and ethnic background of Hispanic/Latino populations in the United States, that otherwise might be missed in a traditional LCM of the overall population. This was achieved using a new model-based clustering method, referred to as robust profile clustering (RPC). Methods A total of 11,320 individuals aged 18–74 y from the Hispanic Community Health Study/Study of Latinos (2008–2011) with complete diet data were classified into 9 subpopulations, defined by study site (Bronx, Chicago, Miami, San Diego) and ethnic background. At baseline, dietary intake was ascertained using a food propensity questionnaire. Dietary patterns were derived from 132 food groups using the RPC method to identify patterns of the general Hispanic/Latino population and those specific to an identified subpopulation. Dietary patterns derived from the RPC were compared to those identified from an LCM. Results The LCM identified 48 shared consumption behaviors of foods and beverages across the entire cohort, whereas significant consumption differences in subpopulations were identified in the RPC model for these same foods. Several foods were common within study site (e.g., chicken, orange juice, milk), ethnic background (e.g., papayas, plantain, coffee), or both (e.g., rice, tomatoes, seafood). Post hoc testing revealed an improved model fit in the RPC model [Deviance Information Criterion DICRPC = 2.3 × 104, DICLCM  = 9.5 × 106]. Conclusions Dietary pattern behaviors of Hispanics/Latinos in the United States tend to align by ethnic background for some foods and by location for other foods. Consideration of both factors is imperative to better understand their contributions to population health and developing targeted nutrition intervention studies.

scholarly journals Patterns of Egg Consumption Can Help Contribute to Nutrient Recommendations and Are Associated with Diet Quality and Shortfall Nutrient Intakes

Nutrients ◽  
2021 ◽  
Vol 13 (11) ◽  
pp. 4094
Author(s):  
Yanni Papanikolaou ◽  
Victor L. Fulgoni
Keyword(s):  
Vitamin E ◽  
Vitamin A ◽  
Vitamin C ◽  
Diet Quality ◽  
Dietary Patterns ◽  
Dietary Pattern ◽  
Healthy Eating Index ◽  
Nutrient Intakes ◽  
Egg Consumption ◽  
Healthy Dietary Pattern

Limited data are available on how eggs are consumed in the typical American eating pattern and the contribution to usual intakes, diet quality and in meeting recommendations. The objectives of the present analysis included identifying how eggs are consumed within U.S. dietary patterns and how these patterns are associated with the usual intakes of shortfall nutrients and diet quality (Healthy Eating Index 2015) using data from the combined National Health and Nutrition Examination Survey (NHANES) from 2001–2016. An additional objective included assessing the differences between egg consumers and egg non-consumers in nutrient intakes and nutrient adequacy. Several egg-containing dietary patterns were identified, and two egg patterns were associated with a greater diet quality compared to a no egg pattern (p < 0.0001). Most egg patterns identified were similar in diet quality scores when compared to the no egg pattern; however, the two egg patterns had lower diet quality scores. Egg consumption combined with a greater intake of total protein foods, seafood and plant protein, total vegetables, total fruit, whole fruit, whole grains and dairy foods, and a lower intake of refined grains and added sugars contributed to an improved diet quality, supporting that no one food is responsible for a healthy dietary pattern. Egg consumers demonstrated significantly higher intakes of dietary fiber, calcium, magnesium, potassium, total choline, vitamin A, vitamin C, vitamin D and vitamin E when compared to egg non-consumers. A comparison of egg consumers and egg non-consumers found egg consumers had significantly less percentages of the population below the EAR for calcium, iron, magnesium, vitamin A, vitamin C and vitamin E. Similarly, the percentage of the population above the recommendations for potassium and choline were greater for egg consumers vs. egg non-consumers. In egg consumers, 24.4% of the population was above the AI for dietary choline when compared to 4.3% of egg non-consumers (p < 0.0001). Findings from the present analysis demonstrate that eggs and egg-containing foods can be an important part of a healthy dietary pattern when balanced accordingly with other nutrient-dense foods.

scholarly journals Dietary Pattern Indices and Incident Peripheral Arterial Disease in Women: A Prospective Cohort Study

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 513-513
Author(s):  
Guochong Chen ◽  
Yasmin Mossavar-Rahmani ◽  
Xiaonan Xue ◽  
Bernhard Haring ◽  
Aladdin Shadyab ◽  
...  
Keyword(s):  
Postmenopausal Women ◽  
Healthy Eating ◽  
Dietary Patterns ◽  
Dietary Pattern ◽  
Lower Risk ◽  
Kidney Diseases ◽  
Healthy Eating Index ◽  
Cox Proportional Hazards ◽  
Processed Meat ◽  
Incident Cases

Abstract Objectives We aimed to evaluate diet quality as reflected by multiple a priori dietary pattern indices in relation to incident PAD. Methods We included 138,506 US postmenopausal women aged 50–79 years without known PAD at baseline (1993–1998) of the Women's Health Initiative. Score of 4 dietary pattern indices, including the alternate Mediterranean diet (aMED) index, the alternate Healthy Eating Index (AHEI)-2010, the Dietary Approaches to Stop Hypertension (DASH) diet index, and the Healthy Eating Index (HEI)-2015, were derived using data collected by a validated food frequency questionnaire. Incident cases of symptomatic PAD in the lower extremities were ascertained and adjudicated through March 2019 by reviewing medical record. Hazard ratios (HR) and 95% confidence interval (CI) were estimated using Cox proportional hazards models, with adjustment for multiple potential confounders including known risk factors for PAD (i.e., smoking, high blood pressure, dyslipidemia, and diabetes). Results During a median 18.6 years of follow-up, 1036 incident cases of PAD were identified. All 4 dietary pattern indices were inversely associated with risk of PAD. The multivariable-adjusted HRs (95% CI) comparing the highest with the lowest score quartiles were 0.74 (0.61–0.91) for aMED index (P-trend across quartile = 0.010), 0.79 (0.65–0.95) for AHEI-2010 (P-trend &lt; 0.001), 0.66 (0.55–0.80) for DASH index (P-trend &lt; 0.001), and 0.68 (0.56–0.82) for HEI-2015 (P-trend &lt; 0.001). Among major foods/nutrients contributing to these dietary patterns, intakes of whole grains (top vs. bottom quartile, HR = 0.81; P-trend = 0.01), legumes (HR = 0.77; P-trend = 0.004), dietary fiber (HR = 0.78; P-trend = 0.01), and vegetable protein (HR = 0.76; P-trend = 0.006) were associated with lower risk of PAD, whereas intakes of red meat (HR = 1.38; P-trend = 0.003), processed meat (HR = 1.36; P-trend = 0.004), and regular soft drinks (HR = 1.26; P-trend = 0.01) were associated with higher risk. Conclusions Adherence to various recommended dietary patterns is associated with lower risk of PAD in a nationwide cohort of US postmenopausal women. Our findings may extend the range of cardiovascular diseases that are potentially preventable by adopting a healthy dietary pattern. Funding Sources National Heart, Lung, and Blood Institute; and National Institute of Diabetes and Digestive and Kidney Diseases.

scholarly journals Dietary patterns and risk of incident chronic kidney disease: the Atherosclerosis Risk in Communities study

2019 ◽  
Vol 110 (3) ◽  
pp. 713-721 ◽  
Author(s):  
Emily A Hu ◽  
Lyn M Steffen ◽  
Morgan E Grams ◽  
Deidra C Crews ◽  
Josef Coresh ◽  
...  
Keyword(s):  
Kidney Disease ◽  
Healthy Eating ◽  
Dietary Patterns ◽  
Lower Risk ◽  
Filtration Rate ◽  
Estimated Glomerular Filtration Rate ◽  
Healthy Eating Index ◽  
Atherosclerosis Risk In Communities ◽  
Atherosclerosis Risk ◽  
Dietary Score

ABSTRACTBackgroundAdherence to healthy dietary patterns, measured by the Healthy Eating Index (HEI), Alternative Healthy Eating Index (AHEI), and alternate Mediterranean diet (aMed) scores, is associated with a reduced risk of cardiovascular disease. The association between these scores and chronic kidney disease (CKD) is undetermined.ObjectiveWe aimed to estimate the association between the HEI, AHEI, and aMed scores and risk of incident CKD.MethodsWe conducted a prospective analysis in 12,155 participants aged 45–64 y from the Atherosclerosis Risk in Communities (ARIC) Study. We calculated HEI-2015, AHEI-2010, and aMed scores for each participant and categorized them into quintiles of each dietary score. Incident CKD was defined as an estimated glomerular filtration rate <60 mL/min/1.73 m2 accompanied by ≥25% decline in estimated glomerular filtration rate, a kidney disease–related hospitalization or death, or end-stage renal disease. We used cause-specific hazard models to estimate risk of CKD from the quintile of the dietary score through to 31 December 2017.ResultsThere were 3980 cases of incident CKD over a median follow-up of 24 y. Participants who had higher adherence to the HEI-2015, AHEI-2010, and aMed scores were more likely to be female, have higher educational attainment, higher income level, be nonsmokers, more physically active, and diabetic compared with participants who scored lower. All 3 dietary scores were associated with lower CKD risk (P-trend < 0.001). Participants who were in the highest quintile of HEI-2015 score had a 17% lower risk of CKD (HR: 0.83; 95% CI: 0.74, 0.92) compared with participants in the lowest quintile. Those in quintile 5 of AHEI-2010 and aMed scores, respectively, had a 20% and 13% lower risk of CKD compared with those in quintile 1.ConclusionHigher adherence to healthy dietary patterns during middle age was associated with lower risk of CKD.

Abstract P077: Differences and Similarities in Dietary Pattern and Nutrient Profiles between the Sexes and Blacks and Whites. The Adventist Health Study 2

Circulation ◽  
2012 ◽  
Vol 125 (suppl_10) ◽  
Author(s):  
Nico S Rizzo ◽  
Karen Jaceldo-Siegl ◽  
Gary Fraser
Keyword(s):  
Dietary Patterns ◽  
Dietary Pattern ◽  
Saturated Fatty Acids ◽  
Linear Regression Analysis ◽  
Health Study ◽  
Nutrient Intakes ◽  
Higher Plant ◽  
Cross Sectional ◽  
Blacks And Whites ◽  
Adventist Health Study

Objective: To describe the associations between dietary patterns with nutrient intakes differentiated by sex and race. Methods: Cross-sectional study of 71751 subjects (mean age 59 years, 65% female, 76% white) from the Adventist Health Study 2. Participants completed a 204-item validated semi-quantitative food frequency questionnaire. Five dietary patterns were established: non vegetarian, semi vegetarians, pesco vegetarians, lacto ovo vegetarians and strict vegetarians. ANCOVA and linear regression analysis were used to determine differences of nutrient intakes by dietary patterns. Non-dietary variables, such as age, smoking and physical activity were taken into account and associations between dietary pattern and BMI were compared. Analysis was repeated by stratifying for sex and race. Results: Strict vegetarians had the lowest BMI, with graded higher BMI levels for dietary patterns with greater fractions of animal plant protein, total fat and saturated fatty acids but similar total caloric intakes. Mean nutrient intake was more dissimilar across dietary pattern than between the sexes or blacks and whites. In general nutrient intakes were more similar between males and females than between blacks and whites with blacks revealing a strikingly higher percentage of non vegetarians than whites. Supplement intakes were often markedly higher in females than in males and higher in whites than in blacks with mean micronutrient intakes for all dietary patterns being well above the estimated average requirements for American adults in both sexes and blacks and whites. Conclusions: All groups met current American nutrient requirements. Nutrient intakes varied more markedly between dietary pattern than between sex or race. Lower BMI levels were associated with dietary patterns characterized by higher plant food intake despite generally similar caloric intake across dietary patterns warranting further investigation.

Prospective Study of Plant-Based Dietary Patterns and Diabetes in Puerto Rican Adults

2021 ◽  
Author(s):  
Ashley C Flores ◽  
Christopher Heron ◽  
Jung In Kim ◽  
Bryan Martin ◽  
Laila Al-Shaar ◽  
...  
Keyword(s):  
Puerto Rican ◽  
Dietary Patterns ◽  
Diabetes Management ◽  
Depressive Symptomatology ◽  
Plasma Concentrations ◽  
Cox Proportional Hazards ◽  
Hypoglycemic Agents ◽  
Health Study ◽  
Dietary Index

ABSTRACT Background Vegetarian-type dietary patterns have been associated with reducing the risk of developing diabetes and may function as an effective strategy for diabetes management. Objectives We aimed to examine the associations between adherence to plant-based diet indices and the risk of developing diabetes in the Boston Puerto Rican Health Study. Methods Puerto Rican adults (n = 646), aged 45–75 y and free of diabetes at baseline, were included. Dietary intake was assessed via a validated FFQ. Three plant-based dietary indices were calculated: an overall plant-based diet index (PDI), a healthful plant-based diet index (hPDI), and an unhealthful plant-based diet index (uPDI). Incident diabetes was defined as fasting plasma glucose ≥ 126 mg/dL (7.0 mmol/L), glycated hemoglobin ≥ 6.5% (48 mmol/mol), or use of hypoglycemic agents during follow-up. Cox proportional hazards were used to evaluate associations between the dietary patterns and incidence of diabetes, adjusting for potential confounders, such as age, sex, socioeconomic status, lifestyle factors, obesity, total energy intake, depressive symptomatology, and plasma concentrations of lipids. Results During a mean of 4.2 y of follow-up, we identified 134 diabetes cases. After adjustment for covariates, higher hPDI was associated with lower risk of developing diabetes (adjusted HR for the highest compared with the lowest tertile: 0.54; 95% CI: 0.31, 0.94; P-trend = 0.03). In contrast, the PDI and uPDI were not significantly associated with the risk of diabetes (P-trend &gt; 0.3 for both). Conclusions The healthful plant-based dietary index, but not the total plant-based dietary index, was inversely associated with diabetes risk. These findings suggest that the quality of plant-based diets must be considered when recommending plant-based diets for the prevention of diabetes. This trial was registered at clinicaltrials.gov as NCT01231958.

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