BackgroundObesity has reached epidemic proportions in the United States. It is implicated in the development of a variety of chronic disease states and is associated with increased levels of inflammation and oxidative stress. The objective of this study is to examine the effect of Medifast's meal replacement program (MD) on body weight, body composition, and biomarkers of inflammation and oxidative stress among obese individuals following a period of weight loss and weight maintenance compared to a an isocaloric, food-based diet (FB).MethodsThis 40-week randomized, controlled clinical trial included 90 obese adults with a body mass index (BMI) between 30 and 50 kg/m2, randomly assigned to one of two weight loss programs for 16 weeks and then followed for a 24-week period of weight maintenance. The dietary interventions consisted of Medifast's meal replacement program for weight loss and weight maintenance, or a self-selected, isocaloric, food-based meal plan.ResultsWeight loss at 16 weeks was significantly better in the Medifast group (MD) versus the food-based group (FB) (12.3% vs. 6.9%), and while significantly more weight was regained during weight maintenance on MD versus FB, overall greater weight loss was achieved on MD versus FB. Significantly more of the MD participants lost ≥ 5% of their initial weight at week 16 (93% vs. 55%) and week 40 (62% vs. 30%). There was no difference in satiety observed between the two groups during the weight loss phase. Significant improvements in body composition were also observed in MD participants compared to FB at week 16 and week 40. At week 40, both groups experienced improvements in biochemical outcomes and other clinical indicators.ConclusionsOur data suggest that the meal replacement diet plan evaluated was an effective strategy for producing robust initial weight loss and for achieving improvements in a number of health-related parameters during weight maintenance, including inflammation and oxidative stress, two key factors more recently shown to underlie our most common chronic diseases.Trial RegistrationClinicalTrials.gov NCT01011491
Background:The potential for the use of nutritional screening to identify older persons at risk of hospitalization has not been contrasted with the use of tools developed for predicting hospital admissions. Objective: Our goal was to compare the associations of items from the Level II Nutrition Screen (LII) and the Probability of Repeated Admissions (P ra ) questionnaire with the outcome of hospitalization. Design: This was a cohort study of participants in a Medicare managed-risk health plan who completed both the LII and P ra (n = 386). All hospitalizations within 1 y of screening were recorded. Hierarchical multivariate logistic regression was used to model associations with hospitalization. Results: P ra items that retained significant associations with hospitalization were self-reported health, hospitalization in the past year, and > 6 doctor visits in the past year (positive predictive value: 20%; sensitivity: 53.1; specificity: 69.7). LII items that retained significant associations with hospitalization were eating problems and polypharmacy (positive predictive value: 17.9%; sensitivity: 58.0; specificity: 56.3). Those persons designated by the P ra score as being at high risk of hospitalization (P ra ≥ 0.30, 75th percentile) were also more likely to report weight loss, polypharmacy, consumption of a special diet, and functional limitation on the LII. Conclusions: Retained items from the P ra and the LII were comparable in identifying participants at risk of hospitalization. These observations suggest that nutritional risk factors such as eating problems, weight loss, and consumption of special diets should be considered in the management of older persons at risk of hospitalization, irrespective of the screening approach selected.
Background: Increasing protein content of the diet might be an effective strategy to preserve muscle mass in older adults undergoing caloric restriction, thereby preserving muscle function. Methods: Ninety-six older adults (70.3 ± 3.7 years, 74% women, 27% African American) with obesity (35.4 ± 3.3 kg/m 2 ; 47% total body fat) were randomized to a 6-month higher protein (providing 1.2-1.5 g/kg/d) weight loss (WL) program, utilizing the Medifast 4&2&1 Plan, or to weight stability (WS). Dual-energy x-ray absorptiometry-acquired total body mass and composition, and fast gait speed over 400 m was assessed at baseline, 3, and 6 months. Results: At baseline, dual-energy x-ray absorptiometry-acquired total body, fat, and lean masses were 95.9 ± 14.6, 44.6 ± 7.6, and 48.7 ± 9.5 kg, respectively, and 400-m gait speed was 1.17 ± 0.20 m/s. Total body mass was significantly reduced in the WL group (−8.17 [−9.56, −6.77] kg) compared with the WS group (−1.16 [−2.59, 0.27] kg), with 87% of total mass lost as fat (WL: −7.1 [−8.1, −6.1] kg; −15.9% change from baseline). A differential treatment effect was not observed for change in lean mass (WL: −0.81 [−1.40, −0.23] kg vs WS: −0.24 [−0.85, 0.36] kg). Four-hundred-meter gait speed was also unchanged from baseline although trends suggest slightly increased gait speed in the WL group [0.01 (−0.02, 0.04) m/s] compared with the WS group [−0.02 (−0.05, 0.01) m/s]. Conclusion: Intentional weight loss using a high-protein diet is effective in producing significant total body mass and fat mass loss, while helping preserve lean body mass and mobility, in relatively high-functioning older adults with obesity.
BackgroundRecent medical guidelines emphasize the importance of actively treating overweight and obesity with diet and lifestyle intervention to achieve ≥5 % weight loss in a 6-month period. Commercial programs offer one approach provided there is evidence of their efficacy and safety. This study was conducted to evaluate the effectiveness of the Medifast® 4 & 2 & 1 Plan™ on weight loss, body composition and cardiometabolic risk factors in overweight and obese adults.MethodsA systematic retrospective chart review of 310 overweight and obese clients following the Medifast 4 & 2 & 1 Plan at one of 21 Medifast Weight Control Centers® was conducted. Data were recorded electronically and key data points were independently verified. The primary endpoint was change from baseline body weight at 12 weeks. Within group paired t-tests were used to examine changes from baseline in a completers population. Differences between gender and age subgroups were examined using bivariate t-tests and mixed model regression analyses.ResultsFor the primary endpoint at 12 weeks, body weight among completers (n = 185) was reduced by a mean of 10.9 ± 5.6 kg (-10.1 %, p < 0.0001), and at 24 weeks (n = 81) mean weight was reduced by 16.0 ± 7.9 kg (-14.3 %). At 12 and 24 weeks, 85 % and 96 % of those remaining on the plan, respectively, had lost ≥5 % of their baseline body weight. Lean mass was preserved to within 5 % of baseline throughout the 24 weeks, and fat mass represented ≥80 % of the body weight lost from 12 weeks onward. Men, women, seniors (≥65 years), and non-seniors (<65 years) all had significant weight reductions with preservation of lean mass. Significant improvements in blood pressure, pulse and waist-to-hip ratio were observed. Mean weight regain among the subset who entered a formal maintenance phase was <2 % during an average follow-up of 34 weeks. The meal plan was well tolerated, and program adherence was >85 %.ConclusionsThe 4 & 2 & 1 Plan used at Medifast Weight Control Centers was effective for weight loss, preservation of lean mass and improvement in cardiometabolic risk factors. The plan was generally well tolerated in a broad population of overweight and obese adults. #NCT02150837.Electronic supplementary materialThe online version of this article (doi:10.1186/s12937-015-0062-8) contains supplementary material, which is available to authorized users.
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