Changes in Glycemic Load Are Positively Associated with Small Changes in Primary Stress Markers of Allostatic Load in Puerto Rican Women.

BACKGROUND: Puerto Ricans experience a high prevalence of type 2 diabetes. Dietary glycemic load (GL) and allostatic load (AL) have been linked with diabetes. AL, the wear and tear on the body from chronic stress, starts with secretion of primary stress markers from activation of the hypothalamic-pituitary-adrenal (HPA) axis, sympathetic nervous system (SNS), and immune system. GL can act as a physiological stressor, contributing to the primary AL response. OBJECTIVE: We examined the relation between GL and a composite score of primary stress markers of AL in Puerto Rican adults. METHODS: Data were from the Boston Puerto Rican Health Study, a cohort study of Puerto Ricans, aged 45-75 y, including 262 men and 697 women with complete data at baseline and 2-y follow-up. GL was calculated from dietary intake obtained with an FFQ. Sex-specific composite primary AL scores included markers of the HPA axis (cortisol and dehydroepiandrosterone sulfate), SNS (epinephrine and norepinephrine), and immune system (C-reactive protein). Linear regression models were stratified by sex and adjusted for covariates. RESULTS: Mean ± SD baseline GL score was 155 ± 28 for men and 135 ± 34 for women. Mean primary stress AL score was 1.25 ± 1.14 for men and 1.25 ± 1.06 for women. GL was not associated with AL score in men. In women, increasing GL from baseline to 2 y was significantly associated with increasing AL, after adjusting for sociodemographics, physical activity, smoking, BMI, menopause, and baseline AL score (ß = 0.03; P = 0.049). Results became marginally significant after further adjustment for chronic diseases (P = 0.06) and intake of fats (P values: saturated fats = 0.08; trans fats = 0.06; unsaturated fats = 0.07), but the magnitude of the association remained unchanged. CONCLUSIONS: Increasing GL over 2 y was positively associated with increasing composite score of primary markers of AL in Puerto Rican women. More studies are needed to confirm our findings.

Impact of incident diabetes on atherosclerotic cardiovascular disease according to statin use history among postmenopausal women.

To compare impact of incident diabetes on atherosclerotic cardiovascular disease (ASCVD) risk among postmenopausal women according to statin use. Prospective data from 120,499 postmenopausal women without prevalent diabetes or cardiovascular disease at baseline from the Women's Health Initiative were used. Incident diabetes was self-reported annually and defined as treatment with pills or injectable medication for diabetes. Current statin use was determined at enrollment and years 1, 3, 6, 9 and 13.5 in the three clinical trial arms, and at baseline, year 3, and 13.5 for the observational study. The primary outcome was incident ASCVD events, self-reported annually and adjudicated by blinded local and central physicians. Incident diabetes and statin use status were fitted as time-varying covariates in Cox regression models to assess ASCVD risk during an average follow-up of 13.6 years. For those not on statins at the time of diabetes diagnosis, there was a 42 % increased risk of ASCVD [hazard ratio (HR) 1.42, 95 % CI 1.28-1.58] among women with incident diabetes versus those without diabetes. Among women on statins, there was a 39 % increased risk of ASCVD (HR 1.39, 95 % CI 1.12-1.74) in women with incident diabetes versus those without diabetes. The increased ASCVD risk due to diabetes was similar between women before or after initiating statins (P = 0.89). Whether diabetes was diagnosed before or after statin use did not alter the increased risk of ASCVD associated with diabetes. Mitigating the increased incidence of diabetes in statin users could increase the ASCVD benefit-to-risk ratio of statins.

Single-component versus multicomponent dietary goals for the metabolic syndrome: a randomized trial.

BACKGROUND: Few studies have compared diets to determine whether a program focused on 1 dietary change results in collateral effects on other untargeted healthy diet components. OBJECTIVE: To evaluate a diet focused on increased fiber consumption versus the multicomponent American Heart Association (AHA) dietary guidelines. DESIGN: Randomized, controlled trial from June 2009 to January 2014. (ClinicalTrials.gov: NCT00911885). SETTING: Worcester, Massachusetts. PARTICIPANTS: 240 adults with the metabolic syndrome. INTERVENTION: Participants engaged in individual and group sessions. MEASUREMENTS: Primary outcome was weight change at 12 months. RESULTS: At 12 months, mean change in weight was -2.1 kg (95% CI, -2.9 to -1.3 kg) in the high-fiber diet group versus -2.7 kg (CI, -3.5 to -2.0 kg) in the AHA diet group. The mean between-group difference was 0.6 kg (CI, -0.5 to 1.7 kg). During the trial, 12 (9.9%) and 15 (12.6%) participants dropped out of the high-fiber and AHA diet groups, respectively (P = 0.55). Eight participants developed diabetes (hemoglobin A1c level ≥6.5%) during the trial: 7 in the high-fiber diet group and 1 in the AHA diet group (P = 0.066). LIMITATIONS: Generalizability is unknown. Maintenance of weight loss after cessation of group sessions at 12 months was not assessed. Definitive conclusions cannot be made about dietary equivalence because the study was powered for superiority. CONCLUSION: The more complex AHA diet may result in up to 1.7 kg more weight loss; however, a simplified approach to weight reduction emphasizing only increased fiber intake may be a reasonable alternative for persons with difficulty adhering to more complicated diet regimens. PRIMARY FUNDING SOURCE: National Heart, Lung, and Blood Institute.

A population-based dietary inflammatory index predicts levels of C-reactive protein in the Seasonal Variation of Blood Cholesterol Study (SEASONS).

OBJECTIVE: To perform construct validation of the population-based Dietary Inflammatory Index (DII) using dietary data from two different dietary assessments and serum high-sensitivity C-reactive protein (hs-CRP) as the construct validator. DESIGN: Using data derived from (i) three 24 h dietary recalls (24HR) at baseline and at the end of each subsequent quarter (i.e. up to fifteen over a year) and (ii) a 7 d dietary recall (7DDR) measured at baseline and then quarterly, regression analyses were conducted to test the effect of the DII score on serum hs-CRP as dichotomous (≤3 mg/l, >3 mg/l), while controlling for important potential confounders. SETTING: Existing data from the Seasonal Variation of Blood Cholesterol Study (SEASONS), a longitudinal observational study of healthy participants recruited in Worcester, MA, USA and participants were followed for 1 year. SUBJECTS: Participants who had at least one hs-CRP measurement over her/his 1-year participation (n 495 for 24HR, n 559 for 7DDR). RESULTS: Higher DII scores were associated with values of hs-CRP >3 mg/l (OR = 1·08; 95 % CI 1·01, 1·16, P = 0·035 for the 24HR; and OR = 1·10; 95 % CI 1·02, 1·19, P = 0·015 for the 7DDR). CONCLUSIONS: The population-based DII was associated with interval changes in hs-CRP using both the 24HR and 7DDR. The success of this first-of-a-kind attempt at relating individuals' intakes of inflammation-modulating foods using this refined DII, and the finding that there is virtually no drop-off in predictive capability using a structured questionnaire in comparison to the 24HR standard, sets the stage for use of the DII in a wide variety of other epidemiological and clinical studies.

All-cause, cardiovascular, and cancer mortality rates in postmenopausal white, black, Hispanic, and Asian women with and without diabetes in the United States: the Women's Health Initiative, 1993-2009.

Using data from the Women's Health Initiative (1993-2009; n = 158,833 participants, of whom 84.1% were white, 9.2% were black, 4.1% were Hispanic, and 2.6% were Asian), we compared all-cause, cardiovascular, and cancer mortality rates in white, black, Hispanic, and Asian postmenopausal women with and without diabetes. Cox proportional hazard models were used for the comparison from which hazard ratios and 95% confidence intervals were computed. Within each racial/ethnic subgroup, women with diabetes had an approximately 2-3 times higher risk of all-cause, cardiovascular, and cancer mortality than did those without diabetes. However, the hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups. Population attributable risk percentages (PARPs) take into account both the prevalence of diabetes and hazard ratios. For all-cause mortality, whites had the lowest PARP (11.1, 95% confidence interval (CI): 10.1, 12.1), followed by Asians (12.9, 95% CI: 4.7, 20.9), blacks (19.4, 95% CI: 15.0, 23.7), and Hispanics (23.2, 95% CI: 14.8, 31.2). To our knowledge, the present study is the first to show that hazard ratios for mortality outcomes were not significantly different between racial/ethnic subgroups when stratified by diabetes status. Because of the "amplifying" effect of diabetes prevalence, efforts to reduce racial/ethnic disparities in the rate of death from diabetes should focus on prevention of diabetes.

Can attention control conditions have detrimental effects on behavioral medicine randomized trials?

OBJECTIVE: Attention control (AC) conditions are used to balance nonspecific attention in randomized trials of behavioral interventions. Very little guidance about which behavioral interventions and outcomes merit AC is available in the literature. The primary aim of the present study is to demonstrate a scenario in which use of AC in a behavioral randomized trial was unnecessary and possibly detrimental. METHODS: Exploratory analyses were performed in a randomized controlled trial that tested whether a patient-centered counseling intervention reduced low-density lipoprotein cholesterol levels in 355 participants with peripheral arterial disease, compared with AC and usual care (UC) conditions. The patient-centered counseling intervention was designed to activate participants to ask their physician for lipid-lowering medication and/or increase dose intensity, increase medication adherence, and reduce fat intake. The AC condition involved attention-matched telephone-delivered health education, and the UC condition consisted of an educational pamphlet. RESULTS: At 12-month follow-up, the mean low-density lipoprotein cholesterol changes were -11.1 and -6.8 mg/dL in the UC and AC conditions, respectively (p=.17). The proportion of participants who increased the use or dose intensity of medication was significantly lower in AC than in UC: 17.5% versus 30.5% (p=.03). No significant difference in other outcomes was observed between AC and UC. CONCLUSIONS: AC has significantly worse medication outcomes, and there is no indication of a therapeutic effect on other end points. Implications for the use of AC in behavioral randomized trials are discussed. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00217919.

Phone-delivered mindfulness training for patients with implantable cardioverter defibrillators: results of a pilot randomized controlled trial.

BACKGROUND: The reduction in adrenergic activity and anxiety associated with meditation may be beneficial for patients with implantable cardioverter defibrillators. PURPOSE: This study aims to determine the feasibility of a phone-delivered mindfulness intervention in patients with defibrillators and to obtain preliminary indications of efficacy on mindfulness and anxiety. METHODS: Clinically stable outpatients were randomized to a mindfulness intervention (eight weekly individual phone sessions) or to a scripted follow-up phone call. We used the Hospital Anxiety and Depression Scale and the Five Facets of Mindfulness to measure anxiety and mindfulness, and multivariate linear regression to estimate the intervention effect on pre-post-intervention changes in these variables. RESULTS: We enrolled 45 patients (23 mindfulness and 22 control; age, 43-83; 30 % women). Retention was 93 %; attendance was 94 %. Mindfulness (beta = 3.31; p = 0.04) and anxiety (beta = -1.15; p = 0.059) improved in the mindfulness group. CONCLUSIONS: Mindfulness training can be effectively phone-delivered and may improve mindfulness and anxiety in cardiac defibrillator outpatients.

Vitamin D supplementation and depression in the women's health initiative calcium and vitamin D trial.

While observational studies have suggested that vitamin D deficiency increases risk of depression, few clinical trials have tested whether vitamin D supplementation affects the occurrence of depression symptoms. The authors evaluated the impact of daily supplementation with 400 IU of vitamin D(3) combined with 1,000 mg of elemental calcium on measures of depression in a randomized, double-blinded US trial comprising 36,282 postmenopausal women. The Burnam scale and current use of antidepressant medication were used to assess depressive symptoms at randomization (1995-2000). Two years later, women again reported on their antidepressant use, and 2,263 completed a second Burnam scale. After 2 years, women randomized to receive vitamin D and calcium had an odds ratio for experiencing depressive symptoms (Burnam score ≥0.06) of 1.16 (95% confidence interval: 0.86, 1.56) compared with women in the placebo group. Supplementation was not associated with antidepressant use (odds ratio = 1.01, 95% confidence interval: 0.92, 1.12) or continuous depressive symptom score. Results stratified by baseline vitamin D and calcium intake, solar irradiance, and other factors were similar. The findings do not support a relation between supplementation with 400 IU/day of vitamin D(3) along with calcium and depression in older women. Additional trials testing higher doses of vitamin D are needed to determine whether this nutrient may help prevent or treat depression.

Prospective analysis of association between use of statins and melanoma risk in the Women's Health Initiative.

BACKGROUND: Melanoma is the most lethal form of skin cancer, with an estimated 68,130 new cases and 8700 deaths in the United States in 2010. The increasing incidence and high death rate associated with metastatic disease support the need to focus on prevention. The authors used data from the Women's Health Initiative (WHI) to assess whether 3-hydroxy-3 methylglutaryl coenzyme A inhibitors (statins) are associated with a decreased risk of melanoma. METHODS: The study population consisted of 119,726 postmenopausal white women, in which 1099 cases of malignant melanoma were identified over an average (± standard deviation) of 11.6 ± 3.2 years. All diagnoses were confirmed by medical record review and pathology reports. Information on statin use was collected at baseline and during follow-up. Self-administered and interview-administered questionnaires were used to collect information on other risk factors. Cox proportional hazards regression was used to calculate hazard ratios (HRs) with 95% confidence intervals (CIs). Analyses investigated the association of any statin use, type, potency, lipophilic status, and duration of use with melanoma. RESULTS: Statins were used by 8824 women (7.4%) at baseline. The annualized rate of melanoma was 0.09% among statin users and 0.09% among nonusers The multivariable adjusted HR for statin users compared with nonusers was 1.14 (95% CI, 0.91-1.43). There were no significant differences in risk based on statin type, potency, category, duration, or in time-dependent models. CONCLUSIONS: There was no significant association between statin use and melanoma risk among postmenopausal women in the WHI.

Outcomes of a Latino community-based intervention for the prevention of diabetes: the Lawrence Latino Diabetes Prevention Project.

OBJECTIVES: We tested the effectiveness of a community-based, literacy-sensitive, and culturally tailored lifestyle intervention on weight loss and diabetes risk reduction among low-income, Spanish-speaking Latinos at increased diabetes risk. METHODS: Three hundred twelve participants from Lawrence, Massachusetts, were randomly assigned to lifestyle intervention care (IC) or usual care (UC) between 2004 and 2007. The intervention was implemented by trained Spanish-speaking individuals from the community. Each participant was followed for 1 year. RESULTS: The participants' mean age was 52 years; 59% had less than a high school education. The 1-year retention rate was 94%. Compared with the UC group, the IC group had a modest but significant weight reduction (-2.5 vs 0.63 lb; P = .04) and a clinically meaningful reduction in hemoglobin A1c (-0.10% vs -0.04%; P = .009). Likewise, insulin resistance improved significantly in the IC compared with the UC group. The IC group also had greater reductions in percentage of calories from total and saturated fat. CONCLUSIONS: We developed an inexpensive, culturally sensitive diabetes prevention program that resulted in weight loss, improved HbA1c, and improved insulin resistance in a high-risk Latino population.

Design and methods for a pilot study of a phone-delivered, mindfulness-based intervention in patients with implantable cardioverter defibrillators.

Background. Meditation practices are associated with a reduction in adrenergic activity that may benefit patients with severe cardiac arrhythmias. This paper describes the design and methods of a pilot study testing the feasibility of a phone-delivered mindfulness-based intervention (MBI) for treatment of anxiety in patients with implantable cardioverter defibrillators (ICDs). Design and Methods. Consecutive, clinically stable outpatients (n = 52) will be screened for study eligibility within a month of an ICD-related procedure or ICD shock and will be randomly assigned to MBI or to usual care. MBI patients will receive eight weekly individual phone sessions based on two mindfulness practices (awareness of breath and body scan) plus home practice with a CD for 20 minutes daily. Patients assigned to usual care will be offered the standard care planned by the hospital. Assessments will occur at baseline and at the completion of the intervention (between 9 and 12 weeks after randomization). The primary study outcome is feasibility; secondary outcomes include anxiety, mindfulness, and number of administered shocks during the intervention period. Conclusions. If proven feasible and effective, phone-delivered mindfulness-based interventions could improve psychological distress in ICD outpatients with serious cardiovascular conditions.

Gender differences in cholesterol-lowering medication prescribing in peripheral artery disease.

Among 320 patients with lower extremity peripheral artery disease (PAD) and low-density lipoprotein-cholesterol (LDL-C) levels > 70 mg/dl, we determined whether male sex, higher education, and greater self-efficacy for willingness to request therapy from one's physician were associated with increases in LDL-C-lowering medication and achievement of an LDL-C level < 70 mg/dl at 1-year follow-up. Participants were enrolled in a randomized controlled clinical trial to determine whether a telephone counseling intervention can help PAD patients achieve an LDL-C level < 70 mg/dl, compared to usual care and attention control conditions, respectively. Adjusting for age, race, comorbidities, PAD severity, and other covariates, male sex (odds ratio = 3.33, 95% confidence interval = 1.64 to 6.77, p = 0.001) was associated with a higher likelihood of adding cholesterol-lowering medication during follow-up, but was not associated with achieving an LDL-C < 70 mg/dl (odds ratio = 1.09, 95% confidence interval = 0.55 to 2.18). No associations of education level or self-efficacy with study outcomes were identified. In conclusion, male PAD patients with baseline LDL-C levels ≥ 70 mg/dl were more likely to intensify LDL-C-lowering medication during 1-year follow-up than female PAD patients. Despite greater increases in LDL-C-lowering medication among female PAD patients, there was no difference in the degree of LDL-C lowering during the study between men and women with PAD.

Religion and healthy lifestyle behaviors among postmenopausal women: the women's health initiative.

Worship attendance has been associated with longer survival in prospective cohort studies. A possible explanation is that religious involvement may promote healthier lifestyle choices. Therefore, we examined whether attendance is associated with healthy behaviors, i.e. use of preventive medicine services, non-smoking, moderate drinking, exercising regularly, and with healthy dietary habits. The population included 71,689 post-menopausal women enrolled in the Women's Health Initiative observational study free of chronic diseases at baseline. Attendance and lifestyle behaviors information was collected at baseline using self-administered questionnaires. Healthy behaviors were modeled as a function of attendance using logistic regression. After adjustment for confounders, worship attendance (less than weekly, weekly, and more than weekly vs. never) was positively associated with use of preventive services [OR for mammograms: 1.34 (1.19, 1.51), 1.41 (1.26, 1.57), 1.33 (1.17, 1.52); breast self exams: 1.14 (1.02, 1.27), 1.33 (1.21, 1.48), 1.25 (1.1, 1.43); PAP smears: 1.22 (1.01, 1.47-weekly vs. none)]; non-smoking: [1.41 (1.35, 1.48), 1.76 (1.69, 1.84), 2.27 (2.15, 2.39)]; moderate drinking [1.35 (1.27, 1.45), 1.60 (1.52, 1.7), 2.19 (2.0, 2.4)]; and fiber intake [1.08 (1.03, 1.14), 1.16 (1.11, 1.22), 1.31 (1.23, 1.39), respectively], but not with regular exercise or with lower saturated fat and caloric intake. These findings suggest that worship attendance is associated with certain, but not all, healthy behaviors. Further research is needed to get a deeper understanding of the relationship between religious involvement and healthy lifestyle behaviors and of the inconsistent patterns in this association.

What are patients actually eating: the dietary practices of cardiovascular disease patients.

PURPOSE OF REVIEW: To examine dietary quality for patients after a coronary heart disease (CHD) event using a selective review. RECENT FINDINGS: Poor dietary quality is a risk for patients before and after CHD events. Although cardiac rehabilitation programs often contain a nutrition education component and are advised for many patients, few patients attend cardiac rehabilitation. The American population experiences many difficulties with adherence to a higher-quality diet. A diet high in dietary quality is important in reducing risk of recurrent disease, yet few patients who have faced life-threatening cardiac events are adherent to such dietary recommendations. SUMMARY: A review of the literature indicates the need for postevent dietary evaluation and effective nutrition counseling with ongoing follow-up. In addition, we need to demonstrate the effectiveness of such approaches.

The dietary quality of persons with heart failure in NHANES 1999-2006.

BACKGROUND: Dietary quality may impact heart failure outcomes. However, the current status of the dietary quality of persons with heart failure has not been previously reported. OBJECTIVE: To describe sodium intake, patient factors associated with sodium intake and overall dietary quality in a national sample of persons with heart failure. DESIGN: Analysis of repeated cross-sectional probability sample surveys using data from National Health and Nutrition Examination Surveys (NHANES) of 1999-2000, 2001-2002, 2003-2004 and 2005-2006. PARTICIPANTS: The study sample consisted of 574 persons with self-reported heart failure (mean age = 70 years; 52% women). MEASUREMENTS: Diet of each survey participant was assessed using single 24 hour recall. Dietary nutrients of interest included sodium, the mainstay of heart failure dietary recommendations, and additionally potassium, calcium, magnesium, fish oils, saturated fat and fiber. Specific dietary goals were based on established guidelines. RESULTS: Mean sodium intake was 2,719 mg, with 34% consuming less than 2,000 mg per day. Patient factors associated with greater sodium intake included male gender, lower education, lower income and no reported diagnosis of hypertension. Mean potassium intake was 2,367 mg/day, with no differences by type of diuretic used or renal disease status. Adherence rates to established guidelines for other nutrients were 13% for calcium, 10% for magnesium, 2% for fish oils, 13% for saturated fat and 4% for fiber. CONCLUSIONS: Dietary quality of persons with self-reported heart failure was poor. Public health approaches and clinical dietary interventions are needed for persons with this increasingly prevalent clinical syndrome.

Attitudes and behavior of peripheral arterial disease patients toward influencing their physician's prescription of cholesterol-lowering medication.

Among 355 peripheral arterial disease (PAD) patients with low density lipoprotein cholesterol (LDL-C) levels > or = 70 mg/dl, we assessed knowledge regarding optimal LDL levels and the importance of LDL-C-lowering therapy. We also assessed PAD participants' behaviors and attitudes regarding their engagement with their physician in treatment decisions for LDL-C lowering. The average baseline LDL-C level of participants was 103.4 mg/dl +/- 30.7 mg/dl. Seventy-six percent of participants were taking at least one cholesterol-lowering medication. Sixty-six percent were unable to define their optimal LDL-C. Only 47% strongly agreed that their own actions and decisions could reduce their LDL-C. Just 29.8% were aware that patients who request specific medications from their physician were more likely to receive them, and 16% had asked their physician whether they should be taking more cholesterol-lowering medication. These findings suggest that further study is needed to identify effective interventions to educate PAD patients and their physicians about the importance of cholesterol-lowering therapy and to encourage PAD patients to participate with their physician in decisions regarding cholesterol-lowering treatment. Clinical Trial Registration - URL: http://www.clinicaltrials.gov. Unique identifier: NCT00217919.

Seasonal and sex variation of high-sensitivity C-reactive protein in healthy adults: a longitudinal study.

BACKGROUND: Cross-sectional studies have reported seasonal variation in high-sensitivity C-reactive protein (hsCRP). However, longitudinal data are lacking. METHODS: We collected data on diet, physical activity, psychosocial factors, physiology, and anthropometric measurements from 534 healthy adults (mean age 48 years, 48.5% women, 87% white) at quarterly intervals over a 1-year period between 1994 and 1998. Using sinusoidal regression models, we estimated peak-to-trough amplitude and phase of the peaks. RESULTS: At baseline, average hsCRP was 1.72 mg/L (men, 1.75 mg/L; women, 1.68 mg/L). Overall seasonal variation amplitude was 0.16 mg/L (95% CI 0.02 to 0.30) and was lower in men (0.10 mg/L, 95% CI -0.11 to 0.31) than in women (0.23 mg/L, 95% CI 0.04 to 0.42). In both sexes, hsCRP peaked in November, with a corresponding trough in May. Relative plasma volume, waist and hip circumference, diastolic blood pressure, and depression scores were major factors associated with changes in amplitude of seasonal variation of hsCRP, and taken together explain most of the observed seasonal change. There was a 20% increase in the percentage of participants classified in the high-risk category for hsCRP (> or =3 mg/L) during late fall and early winter compared with late spring and early summer. CONCLUSIONS: Concentrations of hsCRP were modestly increased in fall and winter compared to summer, with greater seasonal amplitude of variation observed in women. Conventional classification methods fail to consider seasonality in hsCRP and may result in substantial misclassifications in the spring and fall. Future clinical practice and research should take these variations into account.

A new dietary inflammatory index predicts interval changes in serum high-sensitivity C-reactive protein.

Inflammation is associated with a number of chronic conditions, such as cancer and cardiovascular disease. Reducing inflammation may help prevent or treat these conditions. Diet has consistently been shown to modulate inflammation. To facilitate research into the inflammatory effect of diet on health in humans, we sought to develop and validate an Inflammatory Index designed to assess the inflammatory potential of individuals' diets. An Inflammatory Index was developed based on the results of an extensive literature search. Using data from a longitudinal observational study that carefully measured diet and the inflammatory marker, serum high-sensitivity (hs) C-reactive protein (CRP), in approximately 600 adults for 1 y, we conducted analyses to test the effect of Inflammatory Index score on hs-CRP as a continuous and dichotomous (3 mg/L) indicator of inflammatory response, while controlling for important potential confounders. Results based on continuous measures of hs-CRP suggested that an increasing Inflammatory Index score (representing movement toward an antiinflammatory diet) was associated with a decrease in hs-CRP. Analyses using hs-CRP as a dichotomous variable showed that an antiinflammatory diet was associated with a decrease in the odds of an elevated hs-CRP (P = 0.049). The results are consistent with the ability of the Inflammatory Index to predict hs-CRP and provide additional evidence that diet plays a role in the regulation of inflammation, even after careful control of a wide variety of potential confounders.

Methodology of a diabetes prevention translational research project utilizing a community-academic partnership for implementation in an underserved Latino community.

BACKGROUND: Latinos comprise the largest racial/ethnic group in the United States and have 2-3 times the prevalence of type 2 diabetes mellitus as Caucasians. METHODS AND DESIGN: The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a >/= 30% probability of developing diabetes in the next 7.5 years per a predictive equation. The project was conducted in Lawrence, Massachusetts, a predominantly Caribbean-origin urban Latino community. Individuals were identified primarily from a community health center's patient panel, screened for study eligibility, randomized to either a usual care or a lifestyle intervention condition, and followed for one year. Like the efficacious Diabetes Prevention Program (DPP), the LLDPP intervention targeted weight loss through dietary change and increased physical activity. However, unlike the DPP, the LLDPP intervention was less intensive, tailored to literacy needs and cultural preferences, and delivered in Spanish. The group format of the intervention (13 group sessions over 1 year) was complemented by 3 individual home visits and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist. Study measures included demographics, Stern predictive equation components (age, gender, ethnicity, fasting glucose, systolic blood pressure, HDL-cholesterol, body mass index, and family history of diabetes), glycosylated hemoglobin, dietary intake, physical activity, depressive symptoms, social support, quality of life, and medication use. Body weight was measured at baseline, 6-months, and one-year; all other measures were assessed at baseline and one-year. All surveys were orally administered in Spanish. RESULTS: A community-academic partnership enabled the successful recruitment, intervention, and assessment of Latinos at risk of diabetes with a one-year study retention rate of 93%. TRIAL REGISTRATION: NCT00810290.

Design and methods for testing a simple dietary message to improve weight loss and dietary quality.

BACKGROUND: The current food pyramid guidelines have been criticized because of their complexity and the knowledge required for users to understand the recommendations. Simplification of a dietary message to focus on a single key aspect of dietary quality, e.g., fiber intake, may make the message much easier to comprehend and adhere, such that respondents can achieve greater weight loss, better dietary quality and overall metabolic health. METHODS AND DESIGN: This is a randomized controlled clinical trial with two equal sized arms. In total, 240 obese adults who meet diagnostic criteria for the metabolic syndrome will be randomized to one of the two conditions: 1) a high fiber diet and 2) the American Heart Association (AHA) diet. In the high fiber diet condition, patients will be given instruction only on achieving daily dietary fiber intake of 30 g or more. In the AHA diet condition, patients will be instructed to make the several dietary changes recommended by the AHA 2006 guidelines. The trial examines participant weight loss and dietary quality as well as changes in components of the metabolic syndrome, inflammatory biomarkers, low-density lipoprotein cholesterol levels, insulin levels, and glycosolated hemoglobin. Potential mediators, i.e., diet adherence and perceived ease of the diet, and the intervention effect on weight change will also be examined. DISCUSSIONS: The purpose of this paper is to outline the study design and methods for testing the simple message of increasing dietary fiber. If the simple dietary approach is found efficacious for weight loss; and, improves dietary quality, metabolic health, and adherence, it might then be used to develop a simple public health message. TRIAL REGISTRATION: NCT00911885.