Effects of intermittent versus continuous energy restriction for weight loss on diet quality and eating behavior. A randomized trial.

BACKGROUND/OBJECTIVES: Weight loss diets affect food choices and control of eating. We evaluated the effects of intermittent energy restriction (IER) vs. continuous energy restriction (CER) on nutritional composition and eating behavior. SUBJECT/METHODS: Individuals with BMI 30-45 kg/m2, abdominal obesity and ≥1 additional metabolic syndrome component were randomized to IER vs. CER with similar energy restriction. Of 112 participants, 98 completed weighed dietary records and the Three Factor Eating Questionnaire at baseline and three months. In statistical analysis, changes were adjusted for baseline values. RESULTS: Weight loss, energy intake, and macronutrient composition were similar in the IER and CER groups. The CER group reported a greater increase in fruit and berries (45 g/day [95% CI 21, 71] vs. 2 g/day [-28, 33]; p = 0.047) and vegetables (135 g/day [91, 179] vs. 65 g/day [35, 96]; p = 0.010) than the IER group. Fiber intake increased in the CER compared to the IER group (1.0 g/MJ/day [0.8, 1.2] vs. 0.2 [0.0, 0.4]; p < 0.001). Sugar intake was reduced in the CER compared to the IER group (-2.2E% [-3.2, -2.2] vs. -0.1E% [-1.2, 1.0]; p = 0.007). Intakes of folate, potassium, and magnesium decreased more in the IER than the CER group, while vitamin C increased more in the CER group (all p-values <0.014). Both diets improved eating behavior scores, but cognitive restraint increased more in the CER than the IER group (34 [30, 39] vs. 17 [12, 22]; p = 0.013). CONCLUSIONS: Men and women with obesity had more favorable changes in nutritional composition and eating behavior with CER than IER.

Exploring the effect of a lifestyle intervention on cancer risk: 43-year follow-up of the randomized Oslo diet and antismoking study.

BACKGROUND/OBJECTIVES: The Oslo diet and antismoking study showed that counselling for a healthy lifestyle reduced lifelong coronary mortality in high-risk men. We explored whether the same counselling reduced also cancer risk. METHODS: The study randomly allocated males at high coronary risk to either a 5-year intervention for lifestyle changes (cholesterol-lowering dietary changes, weight loss and stopping smoking) or a control group (1 : 1) in 1972/73. We explored the incidence and mortality of all cancers and cancer forms related to smoking, BMI or diet up to 43 years after randomization. RESULTS: A total of 595 men in the intervention and 621 in the control group were included. At inclusion median age was 45 years, 588 (48.4%) subjects were overweight (BMI > 25 kg m-2 ) and 925 (76.1%) current smokers. The intervention did not reduce the risk of cancer after 43 years (adjusted hazard ratio (HR) 0.96, 95% confidence interval (CI) 0.80-1.15). In the first 25 years of follow-up, among the 1088 (89.5%) men who were overweight/obese and/or smokers, the intervention reduced the incidence of those cancer forms related to smoking, BMI or diet (including carcinoma of the respiratory, digestive and urinary tracts; adjusted HR 0.69; 95% CI 0.49-0.99). The intervention had no significant effect on incidence beyond 25 years, or on mortality. CONCLUSIONS: The 5-year counselling for a healthy lifestyle did not reduce the overall cancer risk in the very long term. However, in the first 25 years, the counselling reduced the risk of relevant cancer types in overweight/obese subjects and smokers.

Effect of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk: A randomized 1-year trial.

BACKGROUND & AIMS: Long-term adherence to conventional weight-loss diets is limited while intermittent fasting has risen in popularity. We compared the effects of intermittent versus continuous energy restriction on weight loss, maintenance and cardiometabolic risk factors in adults with abdominal obesity and ≥1 additional component of metabolic syndrome. METHODS & RESULTS: In total 112 participants (men [50%] and women [50%]) aged 21-70 years with BMI 30-45 kg/m2 (mean 35.2 [SD 3.7]) were randomized to intermittent or continuous energy restriction. A 6-month weight-loss phase including 10 visits with dieticians was followed by a 6-month maintenance phase without additional face-to-face counselling. The intermittent energy restriction group was advised to consume 400/600 kcal (female/male) on two non-consecutive days. Based on dietary records both groups reduced energy intake by ∼26-28%. Weight loss was similar among participants in the intermittent and continuous energy restriction groups (8.0 kg [SD 6.5] versus 9.0 kg [SD 7.1]; p = 0.6). There were favorable improvements in waist circumference, blood pressure, triglycerides and HDL-cholesterol with no difference between groups. Weight regain was minimal and similar between the intermittent and continuous energy restriction groups (1.1 kg [SD 3.8] versus 0.4 kg [SD 4.0]; p = 0.6). Intermittent restriction participants reported higher hunger scores than continuous restriction participants on a subjective numeric rating scale (4.7 [SD 2.2] vs 3.6 [SD 2.2]; p = 0.002). CONCLUSIONS: Both intermittent and continuous energy restriction resulted in similar weight loss, maintenance and improvements in cardiovascular risk factors after one year. However, feelings of hunger may be more pronounced during intermittent energy restriction. TRIAL REGISTRATION: www.clinicaltrials.govNCT02480504.

Associations between persistent organic pollutants and metabolic syndrome in morbidly obese individuals.

BACKGROUND AND AIMS: Persons with "metabolically healthy" obesity may develop cardiometabolic complications at a lower rate than equally obese persons with evident metabolic syndrome. Even morbidly obese individuals vary in risk profile. Persistent organic pollutants (POPs) are widespread environmental chemicals that impair metabolic homeostasis. We explored whether prevalence of metabolic syndrome in morbidly obese individuals is associated with serum concentrations of POPs. METHODS AND RESULTS: A cross-sectional study among 161 men and 270 women with BMI >35 kg/m2 and comorbidity, or >40 kg/m2. Circulating concentrations of 15 POPs were stratified by number of metabolic syndrome components. In multiple logistic regression analysis odds ratios between top quartile POPs and metabolic risk factors versus POPs below the top quartile were calculated adjusting for age, gender, body mass index, smoking status, alcohol consumption and cholesterol concentrations. Age-adjusted concentrations of trans-nonachlor and dioxin-like and non-dioxin-like polychlorinated biphenyls (PCBs) increased with number of metabolic syndrome components in both genders (p < 0.001), while the organochlorine pesticides HCB, ß-HCH and p,p'DDE increased only in women (p < 0.008). Organochlorine pesticides in the top quartile were associated with metabolic syndrome as were dioxin-like and non-dioxin-like PCBs (OR 2.3 [95% CI 1.3-4.0]; OR 2.5 [95% CI 1.3-4.8] and 2.0 [95% CI 1.1-3.8], respectively). Organochlorine pesticides were associated with HDL cholesterol and glucose (OR = 2.0 [95% CI = 1.1-3.4]; 2.4 [95% CI = 1.4-4.0], respectively). Dioxin-like PCBs were associated with diastolic blood pressure, glucose and homeostatic model assessment-insulin resistance index (OR = 2.0 [95% CI = 1.1-3.6], 2.1 [95% CI = 1.2-3.6] and 2.1 [95% CI = 1.0-4.3], respectively). CONCLUSION: In subjects with morbid obesity, metabolic syndrome was related to circulating levels of organochlorine pesticides and PCBs suggesting that these compounds aggravate clinically relevant complications of obesity.

Resting heart rate and the risk of cardiovascular disease, total cancer, and all-cause mortality - A systematic review and dose-response meta-analysis of prospective studies.

BACKGROUND AND AIM: Epidemiological studies have reported increased risk of cardiovascular disease, cancer and all-cause mortality with greater resting heart rate, however, the evidence is not consistent. Differences by gender, adjustment for confounding factors, as well as the potential impact of subclinical disease are not clear. A previous meta-analysis missed a large number of studies, and data for atrial fibrillation have not been summarized before. We therefore aimed to clarify these associations in a systematic review and meta-analysis of prospective studies. METHODS AND RESULTS: PubMed and Embase were searched up to 29 March 2017. Summary RRs and 95% confidence intervals (CIs) were calculated using random effects models. Eighty seven studies were included. The summary RR per 10 beats per minute increase in resting heart rate was 1.07 (95% CI: 1.05-1.10, I2 = 61.9%, n = 31) for coronary heart disease, 1.09 (95% CI: 1.00-1.18, I2 = 62.3%, n = 5) for sudden cardiac death, 1.18 (95% CI: 1.10-1.27, I2 = 74.5%, n = 8) for heart failure, 0.97 (95% CI: 0.92-1.02, I2 = 91.4%, n = 9) for atrial fibrillation, 1.06 (95% CI: 1.02-1.10, I2 = 59.5%, n = 16) for total stroke, 1.15 (95% CI: 1.11-1.18, I2 = 84.3%, n = 35) for cardiovascular disease, 1.14 (95% CI: 1.06-1.23, I2 = 90.2%, n = 12) for total cancer, and 1.17 (95% CI: 1.14-1.19, I2 = 94.0%, n = 48) for all-cause mortality. There was a positive dose-response relationship for all outcomes except for atrial fibrillation for which there was a J-shaped association. CONCLUSION: This meta-analysis found an increased risk of coronary heart disease, sudden cardiac death, heart failure, atrial fibrillation, stroke, cardiovascular disease, total cancer and all-cause mortality with greater resting heart rate.

Tobacco smoking and the risk of diverticular disease - a systematic review and meta-analysis of prospective studies.

AIM: This systematic review and meta-analysis aimed to clarify whether tobacco smoking is associated with an increased risk of diverticular disease. METHOD: The PubMed and Embase databases were searched for studies of smoking and diverticular disease up to 19 February 2016. Prospective studies that reported adjusted relative risk (RR) estimates and 95% confidence intervals (CIs) of diverticular disease associated with current or previous smoking were included. Summary RRs were estimated using a random effects model. RESULTS: We identified five prospective studies which comprised 6076 cases of incident diverticular disease (diverticulosis and diverticulitis) among 385 291 participants and three studies with 1118 cases of complications related to diverticular disease (abscess or perforation) among 292 965. The summary RR for incident diverticular disease was 1.36 (95% CI 1.15-1.61, I2  = 84%, n = 4) for current smokers, 1.17 (95% CI 1.05-1.31, I2  = 49%, n = 4) for former smokers and 1.29 (95% CI 1.16-1.44, I2  = 62%, n = 5) for ever smokers. The summary RR was 1.11 (95% CI 0.99-1.25, I2  = 82%, n = 4) per 10 cigarettes per day. Although there was some indication of nonlinearity there was a dose-dependent positive association with increasing number of cigarettes smoked per day. There was some evidence that smoking also increases the risk of complications of diverticular disease, but the number of studies was small. CONCLUSION: The current meta-analysis provides evidence that tobacco smoking is associated with an increased incidence of diverticular disease and related complications.

Physical activity and the risk of preterm birth: a systematic review and meta-analysis of epidemiological studies.

BACKGROUND: Physical activity has been inconsistently associated with risk of preterm birth, and the strength of the association and the shape of the dose-response relationship needs clarification. OBJECTIVES: To conduct a systematic review and dose-response meta-analysis to clarify the association between physical activity and risk of preterm birth. SEARCH STRATEGY: PubMed, Embase and Ovid databases were searched for relevant studies up to 9 February 2017. SELECTION CRITERIA: Studies with a prospective cohort, case-cohort, nested case-control or randomized study design were included. DATA COLLECTION AND ANALYSIS: Data were extracted by one reviewer and checked for accuracy by a second reviewer. Summary relative risks (RRs) were estimated using a random effects model. MAIN RESULTS: Forty-one studies (43 publications) including 20 randomized trials and 21 cohort studies were included. The summary RR for high versus low activity was 0.87 [95% confidence interval (CI): 0.70-1.06, I2 = 17%, n = 5] for physical activity before pregnancy, and it was 0.86 (95% CI: 0.78-0.95, I2 = 0%, n = 30) for early pregnancy physical activity. The summary RR for a 3 hours per week increment in leisure-time activity was 0.90 (95% CI: 0.85-0.95, I2 = 0%, n = 5). There was evidence of a nonlinear association between physical activity and preterm birth, Pnonlinearity < 0.0001, with the lowest risk observed at 2-4 hours per week of activity. CONCLUSION: This meta-analysis suggests that higher leisure-time activity is associated with reduced risk of preterm birth. Further randomized controlled trials with sufficient frequency and duration of activity to reduce the risk and with larger sample sizes are needed to conclusively demonstrate an association. TWEETABLE ABSTRACT: Physically active compared with inactive women have an 10-14% reduction in the risk of preterm birth.

Smoking cessation improves cardiometabolic risk in overweight and obese subjects treated with varenicline and dietary counseling.

BACKGROUND AND AIM: Weight gain after stopping smoking potentially counteracts improvements in cardiometabolic risks. We investigated changes in metabolic syndrome (MetS) components and homeostasis assessment model insulin resistance (HOMA-IR) in smokers given dietary counseling during their quit attempt. METHODS AND RESULTS: Smokers (≥10 cigarettes/day) with BMI 25-40 kg/m2 were randomized to a low-carbohydrate or low-fat diet and treated with a standard course of varenicline for 12 weeks. Quitters were assessed according to the Russell standard (≤5 cigarettes after the quit date) validated with expired breath carbon monoxide (CO) < 10 ppm. Of 122 randomized participants, 108 (89%) completed clinical and laboratory assessments at 12 weeks. As changes in metabolic risk factors did not differ between dietary groups, we combined the groups to compare quitters to continuing smokers. We found similar weight change among 78 validated quitters as 30 continuing smokers (-0.1 ± 3.0 kg vs 0.3 ± 3.1 kg; p = 0.7) and change in waist circumference (-2.0 ± 3.8 cm vs -0.9 ± 3.9 cm; p = 0.2). Changes in triglyceride concentrations (-0.16 ± 0.52 mmol/l vs 0.21 ± 0.95 mmol/l; p = 0.015) and diastolic blood pressure (-0.9 ± 6 mmHg vs 1.9 ± 8 mmHg; p = 0.039) were more favorable in quitters. Changes in other cardiometabolic risks and HOMA-IR did not differ between quitters and continuous smokers, nor did energy intake or resting metabolic rate. CONCLUSION: Dyslipidemia and blood pressure improved and no early weight gain was seen in quitters, suggesting that dietary intervention can mitigate some of the effects of stopping smoking on cardiometabolic risk factors in overweight and obese smokers. CLINICAL TRIALS REGISTRATION: NCT01069458.

The effect of a vegetarian versus conventional hypocaloric diet on serum concentrations of persistent organic pollutants in patients with type 2 diabetes.

BACKGROUND AND AIMS: The aim of this study was to explore the effect of a vegetarian versus conventional diet on the serum levels of persistent organic pollutants (POPs) in patients with T2D after 12 weeks of dietary intervention and to assess their relationships with metabolic parameters. METHODS AND RESULTS: Men and women with T2D were randomly assigned to follow either a vegetarian diet without fish or meat (n = 37) or an isocaloric conventional antidiabetic diet (n = 37). Both diets were energy restricted (minus 500 kcal/day). All foods were provided to the participants. At randomization (week 0) and 12 weeks, the meal test was performed to assess the ß-cell function and serum levels of 24 POPs. Dioxins and dioxin-like POPs were analyzed by isotope dilution high-resolution gas chromatography (HRGC) and mass spectrometry after cleanup of the silica and carbon columns. Non-dioxin-like POPs were analyzed by gas chromatography with an electron capture detector (GC-ECD). Statistical analyses used were repeated-measures analysis of variance (ANOVA), a multivariate regression model, and Pearson's correlations. We observed a statistically nonsignificant trend toward increases in the serum levels of most POPs in response to both hypocaloric diets with no differences between groups. In the groups combined, the change in serum concentrations of total POPs was correlated to changes in HbA1c (r = +0.34; p < 0.01), fasting plasma glucose (r = +0.41; p < 0.01) levels, and ß-cell function measured as insulin secretion at a reference glucose level (r = -0.37; p < 0.01), independent of the changes in body weight and volume of visceral fat. CONCLUSION: Short-term hypocaloric vegetarian and conventional diets did not reduce the POP levels, possibly due to mobilization of fat stores. Our findings support the relationship between POPs and diabetes, especially ß-cell function. TRIAL REGISTRATION: ClinicalTrials.gov number, NCT00883038, completed.

Development of composite outcomes for individual patient data (IPD) meta-analysis on the effects of diet and lifestyle in pregnancy: a Delphi survey.

OBJECTIVE: To develop maternal, fetal, and neonatal composite outcomes relevant to the evaluation of diet and lifestyle interventions in pregnancy by individual patient data (IPD) meta-analysis. DESIGN: Delphi survey. SETTING: The International Weight Management in Pregnancy (i-WIP) collaborative network. Sample Twenty-six researchers from the i-WIP collaborative network from 11 countries. METHODS: A two-generational Delphi survey involving members of the i-WIP collaborative network (26 members in 11 countries) was undertaken to prioritise the individual outcomes for their importance in clinical care. The final components of the composite outcomes were identified using pre-specified criteria. MAIN OUTCOME MEASURES: Composite outcomes considered to be important for the evaluation of the effect of diet and lifestyle in pregnancy. RESULTS: Of the 36 maternal outcomes, nine were prioritised and the following were included in the final composite: pre-eclampsia or pregnancy-induced hypertension, gestational diabetes mellitus (GDM), elective or emergency caesarean section, and preterm delivery. Of the 27 fetal and neonatal outcomes, nine were further evaluated, with the final composite consisting of intrauterine death, small for gestational age, large for gestational age, and admission to a neonatal intensive care unit (NICU). CONCLUSIONS: Our work has identified the components of maternal, fetal, and neonatal composite outcomes required for the assessment of diet and lifestyle interventions in pregnancy by IPD meta-analysis.

A lower reduction in umbilical artery pulsatility in mid-pregnancy predicts higher infant blood pressure six months after birth.

AIM: The Norwegian-based Cardiovascular Risk Reduction Diet in Pregnancy study found that a cholesterol-lowering diet during pregnancy was associated with an accentuated reduction in the umbilical artery pulsatility index. This follow-up study assessed the possible association between the index and the infants' blood pressure at six months of age. METHODS: In the original study, pregnant women consumed an anti-atherogenic or usual diet from gestational weeks 17-20 to birth and underwent Doppler velocimetry at 24, 30 and 36 gestational weeks. In this follow-up study, blood pressure was measured in 105 mother-infant pairs in the intervention group and 106 mother-infant pairs in the control group six months after birth. RESULTS: Mean systolic and diastolic blood pressures were not significantly different between both groups. When the groups were combined, multivariate linear analyses showed that a lower versus higher reduction (≥-0.17 versus <-0.17) in the umbilical artery pulsatility index between gestational weeks 24 and 30 and maternal diastolic blood pressure at six months postpartum were significant predictors of higher infant systolic blood pressure (p = 0.03, 0.01, respectively). CONCLUSION: A lower reduction in umbilical pulsatility index in mid-pregnancy was associated with higher infant blood pressure at six months of age. This suggests that fetoplacental intrauterine factors may influence future cardiovascular risk.

Talking about quitting with people who enjoy smoking

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A high-fibre bean-rich diet versus a low-carbohydrate diet for obesity.

BACKGROUND: High-fibre and low-carbohydrate diets may enhance satiety and promote weight loss. We compared a diet rich in beans aiming to increase dietary fibre and promote weight loss with a low-carbohydrate diet in a randomised controlled trial to assess effect and tolerability of the high-fibre bean-rich diet. METHODS AND RESULTS: One hundred and seventy-three women and men, with a mean body mass index of approximately 36 kg m(-2) (one-fifth with diabetes type 2) were randomised to a high-fibre bean-rich diet that achieved mean (SD) fibre intakes of 35.5 (18.6) g day(-1) for women and 42.5 (30.3) g day(-1) for men, or a low-carbohydrate diet. Both diets were induced gradually over 4 weeks and included a 3-day feeding phase. Among 123 (71.1%) completers at 16 weeks, mean (SD) weight loss was 4.1 (4.0) kg in the high-fibre versus 5.2 (4.5) kg in the low-carbohydrate group [difference, 1.1 kg, 95% confidence interval (CI) = -2.6 to -0.5; P = 0.2], with results similar to the intent-to-treat population. Low-density lipoprotein (LDL)-cholesterol levels decreased with the high-fibre diet (difference in LDL-cholesterol versus low-carbohydrate diet, 0.2 mmol L(-1) , 95% CI = 0.01-0.44 mmol L(-1) ; P = 0.045), as did total cholesterol (P = 0.038), whereas changes in other lipids and glucose did not differ. After 52 weeks, the low-carbohydrate (n = 24) group tended to retain weight loss better than the high-fibre group (P = 0.06), although total cholesterol remained lower with the bean-rich diet (P = 0.049). CONCLUSIONS: A high-fibre bean-rich diet was as effective as a low-carbohydrate diet for weight loss, although only the bean-rich diet lowered atherogenic lipids.

Kiwifruit decreases blood pressure and whole-blood platelet aggregation in male smokers.

Lifestyle modifications to reduce risk factors for cardiovascular diseases such as blood pressure (BP) and smoking have been emphasized. Fruits and vegetables may modify such risk factors. The major aim of this randomized, controlled trial was to investigate the effects of (1) kiwifruits and (2) an antioxidant-rich diet compared with (3) a control group on BP and platelet aggregation (that is, whole-blood platelet aggregation) after 8 weeks in male smokers (age 44-74 years, n=102). The kiwifruit group received 3 kiwifruits per day, whereas the antioxidant-rich diet group received a comprehensive combination of antioxidant-rich foods. In the kiwifruit group, reductions of 10 mm Hg in systolic BP and 9 mm Hg in diastolic BP were observed (P=0.019 and P=0.016 (change from baseline in the kiwifruit group compared with change from baseline in the control group)). In the antioxidant-rich diet group, a reduction of 10 mm Hg in systolic BP was observed among hypertensives (P=0.045). Additionally, a 15% reduction in platelet aggregation and an 11% reduction in angiotensin-converting enzyme activity was observed in the kiwifruit group (P=0.009 and P=0.034). No effects on these parameters were observed in the antioxidant-rich diet group. This study suggest that intake of kiwifruit may have beneficial effects on BP and platelet aggregation in male smokers.

Relationship of vitamin D levels to blood pressure in a biethnic population.

BACKGROUND AND AIMS: Accumulating epidemiological and clinical studies have suggested that vitamin D insufficiency may be associated with hypertension. Blacks tend to have lower vitamin D levels than Whites, but it is unclear whether this difference explains the higher blood pressure (BP) observed in Blacks in a population with healthy lifestyle practices. METHODS AND RESULTS: We examined cross-sectional data in the Adventist Health Study-2 (AHS-2), a cohort of non-smoking, mostly non-drinking men and women following a range of diets from vegan to non-vegetarian. Each participant provided dietary, demographic, lifestyle and medical history data. Measurements of weight, height, waist circumference, percent body fat and blood pressure and fasting blood samples were obtained from a randomly selected non-diabetic sample of 284 Blacks and 284 Whites aged 30-95 years. Multiple regression analyses were used to assess independent relationships between blood pressure and 25(OH)D levels. Levels of 25(OH)D were inversely associated with systolic BP in Whites after control for age, gender, BMI, and use of BP-lowering medications (ß-coefficient -0.23 [95% CI, -0.43, -0.03; p = 0.02]). This relationship was not seen in Blacks (ß-coefficient 0.08 [95% CI, -0.14, 0.30; p = 0.4]). Results were similar when controlling for waist circumference or percentage body fat instead of BMI. No relationship between serum 25(OH)D and diastolic BP was seen. CONCLUSION: Systolic BP is inversely associated with 25(OH)D levels in Whites but not in Blacks. Vitamin D may not be a major contributor to the White-Black differential in BP.

Vegetarian diets and incidence of diabetes in the Adventist Health Study-2.

AIM: To evaluate the relationship of diet to incident diabetes among non-Black and Black participants in the Adventist Health Study-2. METHODS AND RESULTS: Participants were 15,200 men and 26,187 women (17.3% Blacks) across the U.S. and Canada who were free of diabetes and who provided demographic, anthropometric, lifestyle and dietary data. Participants were grouped as vegan, lacto ovo vegetarian, pesco vegetarian, semi-vegetarian or non-vegetarian (reference group). A follow-up questionnaire after two years elicited information on the development of diabetes. Cases of diabetes developed in 0.54% of vegans, 1.08% of lacto ovo vegetarians, 1.29% of pesco vegetarians, 0.92% of semi-vegetarians and 2.12% of non-vegetarians. Blacks had an increased risk compared to non-Blacks (odds ratio [OR] 1.364; 95% confidence interval [CI], 1.093-1.702). In multiple logistic regression analysis controlling for age, gender, education, income, television watching, physical activity, sleep, alcohol use, smoking and BMI, vegans (OR 0.381; 95% CI 0.236-0.617), lacto ovo vegetarians (OR 0.618; 95% CI 0.503-0.760) and semi-vegetarians (OR 0.486, 95% CI 0.312-0.755) had a lower risk of diabetes than non-vegetarians. In non-Blacks vegan, lacto ovo and semi-vegetarian diets were protective against diabetes (OR 0.429, 95% CI 0.249-0.740; OR 0.684, 95% CI 0.542-0.862; OR 0.501, 95% CI 0.303-0.827); among Blacks vegan and lacto ovo vegetarian diets were protective (OR 0.304, 95% CI 0.110-0.842; OR 0.472, 95% CI 0.270-0.825). These associations were strengthened when BMI was removed from the analyses. CONCLUSION: Vegetarian diets (vegan, lacto ovo, semi-) were associated with a substantial and independent reduction in diabetes incidence. In Blacks the dimension of the protection associated with vegetarian diets was as great as the excess risk associated with Black ethnicity.

A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study.

OBJECTIVE: To evaluate the efficacy, safety and tolerability of taranabant in obese and overweight patients. DESIGN: Double-blind, randomized, placebo-controlled study. SUBJECTS: Patients were >or=18 years old, with body mass index of 27-43 kg m(-2), and 51% with metabolic syndrome (MS) randomized to placebo (N=417) or taranabant 2 mg (N=414), 4 mg (N=415) or 6 mg (N=1256) for 104 weeks. MEASUREMENTS: Key efficacy measurements included body weight, waist circumference (WC), lipid and glycemic end points. RESULTS: On the basis of risk/benefit assessments, the 6-mg dose was discontinued during year 1 (patients on 6 mg were down-dosed to 2 mg or placebo) and the 4-mg dose was discontinued during year 2 (patients on 4 mg were down-dosed to 2 mg). Changes from baseline in body weight at week 52 (all-patients-treated population, last observation carried forward analysis) were -2.6, -6.6 and -8.1 kg, respectively, for placebo and taranabant 2 and 4 mg (both doses P<0.001 vs placebo). For patients who completed year 1, changes from baseline in body weight at week 104 were -1.4, -6.4 and -7.6 kg for placebo and taranabant 2 and 4 mg, respectively (both doses P<0.001 vs placebo). The proportions of patients at weeks 52 and 104 who lost at least 5 and 10% of their baseline body weight were significantly higher and the proportions of patients who met criteria for MS were significantly lower for taranabant 2 and 4 mg vs placebo. The incidence of adverse experiences classified in the gastrointestinal, nervous, psychiatric, cutaneous and vascular organ systems were generally observed to be dose related with taranabant vs placebo. CONCLUSION: Taranabant at the 2- and 4-mg dose was effective in achieving clinically significant weight loss over 2 years and was associated with dose-related increases in adverse experiences. On the basis of these and other data, an assessment was made that the overall safety and efficacy profile of taranabant did not support its further development for the treatment of obesity.

Plant sterols from rapeseed and tall oils: effects on lipids, fat-soluble vitamins and plant sterol concentrations.

BACKGROUND AND AIMS: Data comparing the impact of different sources of plant sterols on CVD risk factors and antioxidant levels is scarce. We evaluated the effects of plant sterols from rapeseed and tall oils on serum lipids, lipoproteins, fat-soluble vitamins and plant sterol concentrations. METHODS AND RESULTS: This was a double-blinded, randomized, crossover trial in which 59 hypercholesterolemic subjects consumed 25 g/day of margarine for 4 weeks separated by 1 week washout periods. The two experimental margarines provided 2g/day of plant sterols from rapeseed or tall oil. The control margarine had no added plant sterols. The control margarine reduced LDL cholesterol by 4.5% (95% CI 1.4, 7.6%). The tall and rapeseed sterol margarines additionally reduced LDL cholesterol by 9.0% (95% CI 5.5, 12.4%) and 8.2% (95% CI 5.2, 11.4%) and apolipoprotein B by 5.3% (95% CI 1.0, 9.6%) and 6.9% (95% CI 3.6, 10.2%), respectively. Lipid-adjusted beta-carotene concentrations were reduced by both sterol margarines (P<0.017). alpha-Tocopherol concentrations were reduced by the tall sterol compared to the rapeseed sterol margarine (P=0.001). Campesterol concentrations increased more markedly with the rapeseed sterol versus tall sterol margarine (P<0.001). The rapeseed sterol margarine increased while the tall sterol margarine decreased brassicasterol concentrations (P<0.001). CONCLUSIONS: Plant sterols from tall and rapeseed oils reduce atherogenic lipids and lipoproteins similarly. The rapeseed sterol margarine may have more favorable effects on serum alpha-tocopherol concentrations.

Effects of a low glycemic load diet versus a low-fat diet in subjects with and without the metabolic syndrome.

BACKGROUND AND AIM: Although many studies report benefits of low glycemic diets, the clinical effects as a whole are mixed. The study aim was to compare a low glycemic load (LGL) diet versus a low-fat diet in a trial with a moderately intense dietary intervention in subjects with varying degrees of metabolic syndrome. METHODS AND RESULTS: Men and women aged 30-65 years, with a BMI of 28-40 kg/m(2) (28-35 for women) and at least one criterion of metabolic syndrome were randomized to the two diets. A total of 202 subjects were included, of which 126 (62%) had metabolic syndrome (>or=3 criteria). The completion rate was 81%. At 3 months, weight loss was greater in the LGL group (-4.8+/-3.9 kg versus -3.8+/-3.5 kg; P=0.06) compared to the low-fat group. At 1 year, however, weight loss was similar in both groups (-4.0+/-5.5 kg versus -4.3+/-6.2 kg; n.s.), but waist circumference reduction was less in the LGL group (-3.9+/-5.3 cm versus -5.8+/-6.8 cm; P=0.03). In contrast, diastolic blood pressure decreased significantly more in the LGL group (-4.0+/-8.7 mmHg versus -1.1+/-8.5 mmHg; P=0.02). We also observed a significant interaction between the presence of the metabolic syndrome and the effect of the two diets on waist circumference, with a less favorable effect of the LGL diet in subjects without the syndrome (P=0.039). CONCLUSION: After 12 months, both diets reduced body weight and the metabolic disturbances similarly, but the LGL diet appeared more suitable for subjects with metabolic syndrome, and was less effective in those without it.

Mothers' negative affectivity during pregnancy and food choices for their infants.

OBJECTIVE: The objective of this study was to analyze whether maternal negative affectivity assessed in pregnancy is related with subsequent infant food choices. DESIGN: The study design was a cohort study. SUBJECTS: The subjects were mothers (N=37 919) and their infants participating in the Norwegian Mother and Child Cohort Study conducted by the Norwegian Institute of Public Health. MEASUREMENTS: Maternal negative affectivity assessed prepartum (Hopkins Symptom Checklist 5 (SCL-5) at weeks 17 and 30 of pregnancy), introduction of solid foods by month 3 and feeding of sweet drinks by month 6 (by the reports of the mothers) were analyzed. RESULTS: Mothers with higher negative affectivity were 64% more likely (95% confidence interval 1.5-1.8) to feed sweet drinks by month 6, and 79% more likely (95% confidence interval 1.6-2.0) to introduce solid foods by month 3. These odds decreased to 41 and 30%, respectively, after adjusting for mother's age, body mass index (BMI) and education. CONCLUSION: The maternal trait of negative affectivity is an independent predictor of infant feeding practices that may be related with childhood weight gain, overweight and obesity.