Worksites can be effective for achieving clinically important reductions in body weight and improved cardiometabolic risk factors. This trial was registered at clinicaltrials.gov as NCT01470222.
Objective This study aims to assess the efficacy and safety of Gelesis100, a novel, nonsystemic, superabsorbent hydrogel to treat overweight or obesity. Methods The Gelesis Loss Of Weight (GLOW) study was a 24‐week, multicenter, randomized, double‐blind, placebo‐controlled study in patients with BMI ≥ 27 and ≤ 40 kg/m2 and fasting plasma glucose ≥ 90 and ≤ 145 mg/dL. The co‐primary end points were placebo‐adjusted weight loss (superiority and 3% margin super‐superiority) and at least 35% of patients in the Gelesis100 group achieving ≥ 5% weight loss. Results Gelesis100 treatment caused greater weight loss over placebo (6.4% vs. 4.4%, P = 0.0007), achieving 2.1% superiority but not 3% super‐superiority. Importantly, 59% of Gelesis100‐treated patients achieved weight loss of ≥ 5%, and 27% achieved ≥ 10% versus 42% and 15% in the placebo group, respectively. Gelesis100‐treated patients had twice the odds of achieving ≥ 5% and ≥ 10% weight loss versus placebo (adjusted OR: 2.0, P = 0.0008; OR: 2.1, P = 0.0107, respectively), with 5% responders having a mean weight loss of 10.2%. Patients with prediabetes or drug‐naive type 2 diabetes had six times the odds of achieving ≥ 10% weight loss. Gelesis100 treatment had no apparent increased safety risks. Conclusions Gelesis100 is a promising new nonsystemic therapy for overweight and obesity with a highly desirable safety and tolerability profile.
Objectives:Obesity is associated with hyperactivation of the reward system for high-calorie (HC) versus low-calorie (LC) food cues, which encourages unhealthy food selection and overeating. However, the extent to which this hyperactivation can be reversed is uncertain, and to date there has been no demonstration of changes by behavioral intervention.Subjects and methods:We used functional magnetic resonance imaging to measure changes in activation of the striatum for food images at baseline and 6 months in a pilot study of 13 overweight or obese adults randomized to a control group or a novel weight-loss intervention.Results:Compared to controls, intervention participants achieved significant weight loss (−6.3±1.0 kg versus +2.1±1.1 kg, P<0.001) and had increased activation for LC food images with a composition consistent with that recommended in the behavioral intervention at 6 months versus baseline in the right ventral putamen (P=0.04), decreased activation for HC images of typically consumed foods in the left dorsal putamen (P=0.01). There was also a large significant shift in relative activation favoring LC versus HC foods in both regions (P<0.04).Conclusions:This study provides the first demonstration of a positive shift in activation of the reward system toward healthy versus unhealthy food cues in a behavioral intervention, suggesting new avenues to enhance behavioral treatments of obesity.
The accuracy of stated energy contents of reduced-energy restaurant foods and frozen meals purchased from supermarkets was evaluated. Measured energy values of 29 quick-serve and sit-down restaurant foods averaged 18% more than stated values, and measured energy values of 10 frozen meals purchased from supermarkets averaged 8% more than originally stated. These differences substantially exceeded laboratory measurement error but did not achieve statistical significance due to considerable variability in the degree of underreporting. Some individual restaurant items contained up to 200% of stated values and, in addition, free side dishes increased provided energy to an average of 245% of stated values for the entrees they accompanied. These findings suggest that stated energy contents of reduced-energy meals obtained from restaurants and supermarkets are not consistently accurate, and in this study averaged more than measured values, especially when free side dishes were taken into account. If widespread, this phenomenon could hamper efforts to selfmonitor energy intake to control weight, and could also reduce the potential benefit of recent policy initiatives to disseminate information on food energy content at the point of purchase.The prevalence of obesity has risen markedly in the past 30 years (1), and energy intake has also risen substantially during this period (2,3). Reducing energy intake is therefore a cornerstone of weight management (4,5), and self-monitoring of food intake is widely recommended to facilitate success (6,7). However, achieving energy intake goals through selfmonitoring depends on the accuracy of energy information available for consumed foods.All foods, including those prepared at home, may potentially introduce error in self-monitoring of energy intake, but ready-prepared foods purchased from restaurants and supermarkets may be an area of particular concern. Consumption of these foods has increased in recent years (8,9), and meals purchased away from home are reported to contain more energy than homeprepared foods (10)(11)(12)(13)(14). Furthermore, information on the energy content of restaurant foods is provided without any required verification or oversight (15,16 A pilot study was therefore conducted to assess the accuracy of reported energy contents of restaurant and supermarket foods with reduced energy suitable for weight control. METHODSThis study involved measurement of the energy content of 39 commercially prepared restaurant foods and supermarket frozen convenience meals obtained in the Boston, MA, area, and comparison of measured values with nutrition information stated by the vendor or manufacturer. The restaurant chains included in the study were selected as a convenience sample of quick-serve and sit-down restaurant chains with broad distribution throughout the United States who provided information on nutrient contents (or reliable information was available from other Web sites). Because the goal of the study was to examine the accuracy of stated energy contents ...
National recommendations emphasize self‐monitoring for prevention and treatment of obesity; however, little information is available on the dietary energy contents of meals obtained from non‐chain restaurants, which account for ≈50% of restaurants in the US. Using bomb calorimetry, we determined gross energy of the 42 most popular meals from 34 randomly selected restaurants in the 9 most common ethnic restaurant categories in Massachusetts. Mean energy of the 158 meals was 1327 kcal (95% CI, 1248–1406 kcal), equivalent to 66% of typical daily energy requirements. All individual meal categories provided substantially more energy than required for weight maintenance, 95% of meals provided >;25% of typical daily energy requirements, and 7% provided >;100%. There was a significant effect of ethnic category on meal energy (P≤.(standardized to gross energy) than equivalent non‐chain entrees in the current study (P=.18), and meals contained 16% more energy than national food database information for equivalent meals (P=.0002). Non‐chain restaurants may be important contributors to the obesity epidemic because they provide large amounts of dietary energy that are incompatible with weight management, and at the same time do not typically report any nutrition information. Funding: USDA agreements 58–1950‐0–0014, 1950–51000‐072–02S. Grant Funding Source: USDA agreements with Tufts University
Context National recommendations for the prevention and treatment of obesity emphasize reducing energy intake. Foods purchased in restaurants provide approximately 35% of the daily energy intake in US individuals but the accuracy of the energy contents listed for these foods is unknown. Objective To examine the accuracy of stated energy contents of foods purchased in restaurants. Design and Setting A validated bomb calorimetry technique was used to measure dietary energy in food from 42 restaurants, comprising 269 total food items and 242 unique foods. The restaurants and foods were randomly selected from quick-serve and sit-down restaurants in Massachusetts, Arkansas, and Indiana between January and June 2010. Main Outcome Measure The difference between restaurant-stated and laboratory-measured energy contents, which were corrected for standard metabolizable energy conversion factors. Results The absolute stated energy contents were not significantly different from the absolute measured energy contents overall (difference of 10 kcal/portion; 95% confidence interval [CI], −15 to 34 kcal/portion; P=.52); however, the stated energy contents of individual foods were variable relative to the measured energy contents. Of the 269 food items, 50 (19%) contained measured energy contents of at least 100 kcal/portion more than the stated energy contents. Of the 10% of foods with the highest excess energy in the initial sampling, 13 of 17 were available for a second sampling. In the first analysis, these foods contained average measured energy contents of 289 kcal/portion (95% CI, 186 to 392 kcal/portion) more than the stated energy contents; in the second analysis, these foods contained average measured energy contents of 258 kcal/portion (95% CI, 154 to 361 kcal/portion) more than the stated energy contents (P<.001 for each vs 0 kcal/portion difference). In addition, foods with lower stated energy contents contained higher measured energy contents than stated, while foods with higher stated energy contents contained lower measured energy contents (P<.001). Conclusions Stated energy contents of restaurant foods were accurate overall. However, there was substantial inaccuracy for some individual foods, with understated energy contents for those with lower energy contents.
Efforts to identify a preferable diet for weight management based on macronutrient composition have largely failed, but recent evidence suggests that satiety effects of carbohydrates may depend on the individual’s insulin-mediated cellular glucose uptake. Therefore, using data from the POUNDS LOST trial, pre-treatment fasting plasma glucose (FPG), fasting insulin (FI), and homeostatic model assessment of insulin resistance (HOMA-IR) were studied as prognostic markers of long-term weight loss in four diets differing in carbohydrate, fat, and protein content, while assessing the role of dietary fiber intake. Subjects with FPG <100 mg/dL lost 2.6 (95% CI 0.9;4.4, p = 0.003) kg more on the low-fat/high-protein (n = 132) compared to the low-fat/average-protein diet (n = 136). Subjects with HOMA-IR ≥4 lost 3.6 (95% CI 0.2;7.1, p = 0.038) kg more body weight on the high-fat/high-protein (n = 35) compared to high-fat/average-protein diet (n = 33). Regardless of the randomized diet, subjects with prediabetes and FI below the median lost 5.6 kg (95% CI 0.6;10.6, p = 0.030) more when consuming ≥35 g (n = 15) compared to <35 g dietary fiber/10 MJ (n = 16). Overall, subjects with normal glycemia lost most on the low-fat/high-protein diet, subjects with high HOMA-IR lost most on the high-fat/high protein diet, and subjects with prediabetes and low FI had particular benefit from dietary fiber in the diet.
iDiet participants had clinically impactful mean WL. The observed high mean WL in worksites and videoconference-delivered programs broadens options for scalable WL program implementation.
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