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Background This randomized, double-blind trial evaluated sugammadex-mediated recovery time from rocuronium- or vecuronium-induced moderate (M-) or deep (D-) neuromuscular block in morbidly obese adults dosed by actual (ABW) or ideal body weight (IBW). Methods Adults with BMI ≥40 kg/m 2 were randomized to 1 of 5 groups: M-neuromuscular block, sugammadex 2 mg/kg ABW; M-neuromuscular block, sugammadex 2 mg/kg IBW; M-neuromuscular block, neostigmine 5 mg, and glycopyrrolate 1 mg; D-neuromuscular block, sugammadex 4 mg/kg ABW; or D-neuromuscular block, sugammadex 4 mg/kg IBW. Supramaximal train of four (TOF) stimulation of the ulnar nerve (TOF-watch SX®) monitored recovery. Primary endpoint was time to TOF ratio ≥ 0.9 for ABW and IBW groups pooled across neuromuscular blocking agent (NMBA)/blocking depth, analyzed by log-rank test stratified for agent and depth. Prespecified safety outcomes included treatment-emergent bradycardia, tachycardia, and other arrhythmias, and adjudicated hypersensitivity and anaphylaxis. Results Of 207 patients randomized, 188 received treatment (28% male, BMI 47 ± 5.1 kg/m 2 , age 48 ± 13 years). Recovery was 1.5 min faster with ABW vs IBW dosing. The sugammadex 2 mg/kg groups recovered 9-fold faster [time 0.11-fold, 95% CI 0.08 to 0.14] than the neostigmine group. ABW (5.3%) and IBW (2.7%) groups had similar incidences of recovery time > 10 min (95% CI of difference: − 4.8 to 11.0%); 84% for neostigmine group. Re-curarization occurred in one patient each in the 2 mg/kg IBW and neostigmine groups. Prespecified safety outcomes occurred with similar incidences. Conclusions ABW-based sugammadex dosing yields faster reversal without re-curarization, supporting ABW-based sugammadex dosing in the morbidly obese, irrespective of the depth of neuromuscular block or NMBA used. Trial registration Registered on November 17, 2017, at ClinicalTrials.gov under number NCT03346070 .

Periods of fasting and refeeding may reduce cardiometabolic risk elevated by Western diet. Here we show in the substudy of NCT02099968, investigating the clinical parameters, the immunome and gut microbiome exploratory endpoints, that in hypertensive metabolic syndrome patients, a 5-day fast followed by a modified Dietary Approach to Stop Hypertension diet reduces systolic blood pressure, need for antihypertensive medications, body-mass index at three months post intervention compared to a modified Dietary Approach to Stop Hypertension diet alone. Fasting alters the gut microbiome, impacting bacterial taxa and gene modules associated with short-chain fatty acid production. Cross-system analyses reveal a positive correlation of circulating mucosa-associated invariant T cells, non-classical monocytes and CD4 + effector T cells with systolic blood pressure. Furthermore, regulatory T cells positively correlate with body-mass index and weight. Machine learning analysis of baseline immunome or microbiome data predicts sustained systolic blood pressure response within the fasting group, identifying CD8 + effector T cells, Th17 cells and regulatory T cells or Desulfovibrionaceae, Hydrogenoanaerobacterium, Akkermansia , and Ruminococcaceae as important contributors to the model. Here we report that the high-resolution multi-omics data highlight fasting as a promising non-pharmacological intervention for the treatment of high blood pressure in metabolic syndrome patients. Nutritional modification including fasting has been shown to reduce cardiometabolic risk linked to western diet. Here the authors show implementation of fasting resulted in alterations to the intestinal microbiota, and circulating immune cells, improving blood pressure and body weight in patients with metabolic syndrome.

In an exploratory, block-randomised, parallel, double-blind, single-centre, placebo-controlled superiority study (ISRCTN12562026, funded by Cultech Ltd), 220 Bulgarian participants (30 to 65 years old) with BMI 25–34.9 kg/m 2 received Lab4P probiotic (50 billion/day) or a matched placebo for 6 months. Participants maintained their normal diet and lifestyle. Primary outcomes were changes in body weight, BMI, waist circumference (WC), waist-to-height ratio (WtHR), blood pressure and plasma lipids. Secondary outcomes were changes in plasma C-reactive protein (CRP), the diversity of the faecal microbiota, quality of life (QoL) assessments and the incidence of upper respiratory tract infection (URTI). Significant between group decreases in body weight (1.3 kg, p  < 0.0001), BMI (0.045 kg/m 2 , p  < 0.0001), WC (0.94 cm, p  < 0.0001) and WtHR (0.006, p  < 0.0001) were in favour of the probiotic. Stratification identified greater body weight reductions in overweight subjects (1.88%, p  < 0.0001) and in females (1.62%, p  = 0.0005). Greatest weight losses were among probiotic hypercholesterolaemic participants (−2.5%, p  < 0.0001) alongside a significant between group reduction in small dense LDL-cholesterol (0.2 mmol/L, p  = 0.0241). Improvements in QoL and the incidence rate ratio of URTI (0.60, p  < 0.0001) were recorded for the probiotic group. No adverse events were recorded. Six months supplementation with Lab4P probiotic resulted in significant weight reduction and improved small dense low-density lipoprotein-cholesterol (sdLDL-C) profiles, QoL and URTI incidence outcomes in overweight/obese individuals.

Background and objectivesA plant-based diet is an effective strategy in the treatment of obesity. In this 16-week randomized clinical trial, we tested the effect of a plant-based diet on body composition and insulin resistance. As a part of this trial, we investigated the role of plant protein on these outcomes.Subjects and methodsOverweight participants (n = 75) were randomized to follow a plant-based (n = 38) or a control diet (n = 37). Dual X-ray Absorptiometry assessed body composition, Homeostasis Model Assessment (HOMA-IR) assessed insulin resistance, and a linear regression model was used to test the relationship between protein intake, body composition, and insulin resistance.ResultsThe plant-based vegan diet proved to be superior to the control diet in improving body weight, fat mass, and insulin resistance markers. Only the vegan group showed significant reductions in body weight (treatment effect −6.5 [95% CI −8.9 to −4.1] kg; Gxt, p < 0.001), fat mass (treatment effect −4.3 [95% CI −5.4 to −3.2] kg; Gxt, p < 0.001), and HOMA-IR (treatment effect −1.0 [95% CI −1.2 to −0.8]; Gxt, p = 0.004). The decrease in fat mass was associated with an increased intake of plant protein and decreased intake of animal protein (r = -0.30, p = 0.011; and r = +0.39, p = 0.001, respectively). In particular, decreased % leucine intake was associated with a decrease in fat mass (r = +0.40; p < 0.001), in both unadjusted and adjusted models for changes in BMI and energy intake. In addition, decreased % histidine intake was associated with a decrease in insulin resistance (r = +0.38; p = 0.003), also independent of changes in BMI and energy intake.ConclusionsThese findings provide evidence that plant protein, as a part of a plant-based diet, and the resulting limitation of leucine and histidine intake are associated with improvements in body composition and reductions in both body weight and insulin resistance.

Aims/hypothesis This study aimed to determine whether lifestyle intervention lasting for 4 years affected diabetes incidence, body weight, glycaemia or lifestyle over 13 years among individuals at high risk of type 2 diabetes. Methods Overweight, middle-aged men ( n  = 172) and women ( n  = 350) with impaired glucose tolerance were randomised in 1993–1998 to an intensive lifestyle intervention group ( n  = 265), aiming at weight reduction, dietary modification and increased physical activity, or to a control group ( n  = 257) that received general lifestyle information. The primary outcome was a diagnosis of diabetes based on annual OGTTs. Secondary outcomes included changes in body weight, glycaemia, physical activity and diet. After active intervention (median 4 years, range 1–6 years), participants still free of diabetes and willing to continue their participation (200 in the intervention group and 166 in the control group) were further followed until diabetes diagnosis, dropout or the end of 2009, with a median total follow-up of 9 years and a time span of 13 years from baseline. Results During the total follow-up the adjusted HR for diabetes (intervention group vs control group) was 0.614 (95% CI 0.478, 0.789; p  < 0.001). The corresponding HR during the post-intervention follow-up was 0.672 (95% CI 0.477, 0.947; p  = 0.023). The former intervention group participants sustained lower absolute levels of body weight, fasting and 2 h plasma glucose and a healthier diet. Adherence to lifestyle changes during the intervention period predicted greater risk reduction during the total follow-up. Conclusions/interpretation Lifestyle intervention in people at high risk of type 2 diabetes induces sustaining lifestyle change and results in long-term prevention of progression to type 2 diabetes. Trial registration ClinicalTrials.gov NCT00518167 Funding The DPS study has been financially supported by the Academy of Finland (128315, 129330), Ministry of Education, Novo Nordisk Foundation, Yrjö Jahnsson Foundation, Juho Vainio Foundation, Finnish Diabetes Research Foundation, Finnish Foundation for Cardiovascular Research, Unilever, and Competitive Research Funding from Tampere, Kuopio and Oulu University Hospitals. The study sponsors had no role in the design and conduct of the study; the collection, analysis and interpretation of the data; or the preparation, review or approval of the manuscript.

Abstract Study Objectives To examine the effects of moderate sleep restriction (SR) on body weight, body composition, and metabolic variables in individuals undergoing caloric restriction (CR). Methods Overweight or obese adults were randomized to an 8 week caloric restriction (CR) regimen alone (n = 15) or combined with sleep restriction (CR + SR) (n = 21). All participants were instructed to restrict daily calorie intake to 95 per cent of their measured resting metabolic rate. Participants in the CR + SR group were also instructed to reduce time in bed on five nights and to sleep ad libitum on the other two nights each week. Results The CR + SR group reduced sleep by 57 ± 36 min per day during SR days and increased sleep by 59 ± 38 min per day during ad libitum sleep days, resulting in a sleep reduction of 169 ± 75 min per week. The CR and CR + SR groups lost similar amounts of weight, lean mass, and fat mass. However, the proportion of total mass lost as fat was significantly greater (p = 0.016) in the CR group. This proportion was greater than body fat percentage at baseline for the CR (p = 0.0035), but not the CR + SR group. Resting respiratory quotient was reduced (p = 0.033) only in CR, and fasting leptin concentration was reduced only in CR + SR (p = 0.029). Conclusions Approximately 1 hr of SR on five nights a week led to less proportion of fat mass loss in individuals undergoing hypocaloric weight loss, despite similar weight loss. SR may adversely affect changes in body composition and “catch-up” sleep may not completely reverse it. Clinical trial registration ClinicalTrials.gov (NCT02413866)

Excess weight and obesity are major risk factors for many chronic diseases, and weight-loss interventions often include systematic exercise and nutritional supplements. The purpose of this study was to determine the independent/synergistic effects of Arthrospira (Spirulina) maxima supplementation (six weeks, 4.5 g·day−1) and a systematic physical exercise program (six weeks, twice weekly) on the body composition and cardiorespiratory fitness of overweight and obese subjects. To achieve this, 27 overweight and 25 obese sedentary male subjects were assigned to four interventions through a randomized double-blind, crossover controlled trial: A physical exercise program, with (SE) or without (Ex) Spirulina maxima; or no-exercise program, with (Sm) and without (C) Spirulina maxima. The body composition and cardiorespiratory fitness parameters were taken during a maximum intensity test. As compared to the C group, the body fat percentage of the SE, Sm and Ex groups was reduced (p < 0.05), while their maximal oxygen uptake improved (r = −0.40), and obese subjects benefited more significantly. Weight loss, the time to reach fatigue and the onset of blood lactate accumulation were improved in both of the Spirulina maxima supplemented groups, regardless of the subjects’ body weight. Spirulina maxima supplementation synergistically improves the effects of systematic exercise on body composition and cardiorespiratory fitness parameters in overweight, but mostly in individuals with obesity. Trial registration: Clinical Trials, NCT02837666. Registered 19 July 2016.

ABSTRACT BACKGROUND Previous efforts to use incentives for weight loss have resulted in substantial weight regain after 16 weeks. OBJECTIVE To evaluate a longer term weight loss intervention using financial incentives. DESIGN A 32-week, three-arm randomized controlled trial of financial incentives for weight loss consisting of a 24-week weight loss phase during which all participants were given a weight loss goal of 1 pound per week, followed by an 8-week maintenance phase. PARTICIPANTS Veterans who were patients at the Philadelphia Veterans Affairs Medical Center with BMIs of 30–40. INTERVENTION Participants were randomly assigned to participate in either a weight-monitoring program involving a consultation with a dietician and monthly weigh-ins (control condition), or the same program with one of two financial incentive plans. Both incentive arms used deposit contracts (DC) in which participants put their own money at risk (matched 1:1), which they lost if they failed to lose weight. In one incentive arm participants were told that the period after 24 weeks was for weight-loss maintenance; in the other, no such distinction was made. MAIN MEASURE Weight loss after 32 weeks. KEY RESULTS Results were analyzed using intention-to-treat. There was no difference in weight loss between the incentive arms ( P  = 0.80). Incentive participants lost more weight than control participants [mean DC = 8.70 pounds, mean control = 1.17, P  = 0.04, 95% CI of the difference in means (0.56, 14.50)]. Follow-up data 36 weeks after the 32-week intervention had ended indicated weight regain; the net weight loss between the incentive and control groups was no longer significant (mean DC = 1.2 pounds, 95% CI, -2.58–5.00; mean control = 0.27, 95% CI, -3.77–4.30, P  = 0.76). CONCLUSIONS Financial incentives produced significant weight loss over an 8-month intervention; however, participants regained weight post-intervention.

Effect of Weight Loss With Lifestyle Intervention on Risk of Diabetes Richard F. Hamman , MD, DRPH 1 , Rena R. Wing , PHD 2 , Sharon L. Edelstein , SCM 3 , John M. Lachin , SCD 3 , George A. Bray , MD 4 , Linda Delahanty , MS, RD 5 , Mary Hoskin , MS, RD 6 , Andrea M. Kriska , PHD 7 , Elizabeth J. Mayer-Davis , PHD 8 , Xavier Pi-Sunyer , MD 9 , Judith Regensteiner , PHD 1 , Beth Venditti , PHD 7 , Judith Wylie-Rosett , EDD, RD 10 and for the Diabetes Prevention Program Research Group 1 University of Colorado at Denver and Health Sciences Center, Denver, Colorado 2 Department of Psychiatry and Human Behavior, Brown University, Providence, Rhode Island 3 Biostatistics Center, George Washington University, Washington, DC 4 Pennington Biomedical Research Center, Baton Rouge, Louisiana 5 Diabetes Research Center, Massachusetts General Hospital, Boston, Massachussetts 6 Southwestern Indian Center, National Institute of Diabetes and Digestive and Kidney Diseases, Phoenix, Arizona 7 Department of Epidemiology, University of Pittsburgh Graduate School of Public Health, Pittsburgh, Pennsylvania 8 University of South Carolina School of Public Health, Columbia, South Carolina 9 Roosevelt-St. Luke’s Hospital, New York, New York 10 Albert Einstein College of Medicine, Bronx, New York Address correspondence and reprint requests to Richard F. Hamman, MD, DrPH, Diabetes Prevention Program Coordinating Center, The Biostatistics Center, George Washington University, 6110 Executive Blvd., Suite 750, Rockville, MD 20852. E-mail: dppmail{at}biostat.bsc.gwu.edu Abstract OBJECTIVE —Diabetes Prevention Program (DPP) participants randomized to the intensive lifestyle intervention (ILS) had significantly reduced risk of diabetes compared with placebo participants. We explored the contribution of changes in weight, diet, and physical activity on the risk of developing diabetes among ILS participants. RESEARCH DESIGN AND METHODS —For this study, we analyzed one arm of a randomized trial using Cox proportional hazards regression over 3.2 years of follow-up. RESULTS —A total of 1,079 participants were aged 25–84 years (mean 50.6 years, BMI 33.9 kg/m 2 ). Weight loss was the dominant predictor of reduced diabetes incidence (hazard ratio per 5-kg weight loss 0.42 [95% CI 0.35–0.51]; P < 0.0001). For every kilogram of weight loss, there was a 16% reduction in risk, adjusted for changes in diet and activity. Lower percent of calories from fat and increased physical activity predicted weight loss. Increased physical activity was important to help sustain weight loss. Among 495 participants not meeting the weight loss goal at year 1, those who achieved the physical activity goal had 44% lower diabetes incidence. CONCLUSIONS —Interventions to reduce diabetes risk should primarily target weight reduction. DPP, Diabetes Prevention Program IGR, insulin-to-glucose ratio ILS, intensive lifestyle intervention Footnotes A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances. The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked “advertisement” in accordance with 18 U.S.C. Section 1734 solely to indicate this fact. Accepted June 5, 2006. Received March 14, 2006. DIABETES CARE

Adequate exercise prescription requires a deep understanding of the body’s response to exercise. This study explored the responses of heart rate (HR), muscle oxygen saturation (SmO2), and perceived exertion (RPE) during six body-weight squat exercise variations. A total of 15 recreationally active participants (age: 28.2 ± 8.0 years; body mass: 71.1 ± 11.2 kg; height: 1.73 ± 0.08 m) were recruited. Six body-weight squat variations (deep, jumping, single-leg, uneven, unstable, and wall-sit) were randomly performed for 90 s. Results revealed that the jumping squat promoted a higher average and peak HR (165.3 ± 14.5 and 146.1 ± 14.8 bpm, respectively), and a lower average SmO2 and higher deoxygenation SmO2 in the soleus muscle (40.3 ± 15.4 and 46.0 ± 11.4%, accordingly). No differences were observed in recovery time or in the same SmO2 derived-parameters in the vastus lateralis muscle. The jumping variation promoted a greater response at a physiological level, both centrally, related to cardiovascular response, and peripherally, related to soleus SmO2. It was also the more demanding variation at both the overall and lower limb muscular level of RPE. This holistic view allows a precise identification of the response patterns in body-weight squat exercise variations to an acute session, with a training intervention providing additional information.