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Weight loss at 16 weeks was significantly better in the Medifast group (MD) versus the food-based group (FB) (12.3% vs. Our 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.
BackgroundObesity is a chronic, complex, multifactorial disorder [1] that has reached epidemic proportions in the United States. ResultsSubjectsOf the 90 eligible participants (MD = 45, FB = 45) who began the diet, 48 (53%) completed the 16-week active weight loss phase. 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 dietary interventions consisted of Medifast's meal replacement program for weight loss and weight maintenance, or a self-selected, isocaloric, food-based meal plan.
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. Currently, an estimated 66% of the population is categorized as overweight or obese, and 32.2% obese [2]. Some Medifast meal replacements contain soy, wheat, gluten and nuts so we ensured participants had no known allergies to these ingredients.
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). Significantly more of the MD participants lost a‰? 5% of their initial weight at week 16 (93% vs. Obesity is associated with an increased risk of morbidity and mortality secondary to complicating conditions that include heart disease, diabetes, cancer, asthma, sleep apnea, arthritis, reproductive complications, and psychological disturbances [3]. To avoid the potential affects on calorie intake and compliance, participants consumed a‰¤ 14 alcoholic beverages per week and agreed to avoid alcohol intake during the study. Moreover, obesity is associated with greater degrees of inflammation and oxidative stress [4], which have recently been shown to underlie many chronic conditions, from cardiovascular disease and cancer [5], to metabolic syndrome and nonalcoholic fatty liver disease [6], to neurodegenerative diseases, like Parkinson's disease [7]. Participants were not currently using appetite-affecting medications [e.g selective serotonin reuptake inhibitors (SSRIs), steroids, Ritalin], and were not pregnant or lactating. MD had significantly higher baseline urine ULPs than FB group (p = 0.05), otherwise there were no significant differences at baseline in other outcome measures. Given the prevalence of obesity, its harmful consequences on human health, and the lack of effective treatment options, meal replacement diet plans represent a viable strategy for controlling weight and positively impacting health outcomes.Results of our previous research [8] as well as that of others [9] demonstrate the safety and efficacy of meal replacements for weight loss and weight maintenance among overweight and obese individuals.
Participants were required to have a normal electrocardiogram (EKG) and lab work within the past year as well as the permission of their primary care provider to enroll in the study. There was no difference in satiety observed between the two groups during the weight loss phase.


Evidence has shown that dietary interventions utilizing meal replacements result in greater weight loss [9] better compliance [8, 10], are more likely to ensure adequate intake of essential nutrients [10, 11], and demonstrate higher satisfaction and lower drop-out rates compared to other diets [8, 9, 11, 12].Previous studies have also found improvements in biochemical markers over both the short-term (3-months) and the long-term (a‰? 27 months) [13a€“15] when meal replacements were used as part of a hypocaloric diet. Significant improvements in body composition were also observed in MD participants compared to FB at week 16 and week 40.
More recently, meal replacement diet plans have been shown to improve levels of C-reactive protein, a biomarker of systemic inflammation [16, 17]. At week 40, both groups experienced improvements in biochemical outcomes and other clinical indicators. Increased body weight, percent body fat, and waist circumference have been positively correlated with levels of C-reactive protein [18]. Elevated levels of CRP are associated with an increased risk for insulin resistance, endothelial dysfunction [20], oxidative stress [21], and cardiovascular events [22]. At this visit, written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization were obtained.
Measurements of height, weight, waist circumference (WC), blood pressure, pulse, and body composition using bioelectrical impedance (BIA) were collected.
The loss of body weight, particularly around the abdomen, may lower the risk of chronic diseases like cardiovascular disease by dampening systemic inflammation [4, 5] and reducing levels of oxidative stress [23].Thus, several lines of evidence suggest that hypocaloric meal replacement diet plans may be an effective strategy for fostering weight loss, ensuring compliance, and improving health outcomes in today's obesigenic environment. We therefore sought to evaluate the impact of a previously untested portion-controlled meal replacement diet plan on body weight and body composition compared to an isocaloric, food-based diet plan during a 16-week period of weight loss and 24-week period of weight maintenance. Data on general demographics, medical history, weight history, alcohol and cigarette use, exercise, eating habits, and sources of stress were collected.One hundred fifteen obese adults met initial eligibility criteria and attended the in-person screening. Given the scarcity of existing research evaluating the impact of meal replacements on inflammation and oxidative stress, these biomarkers were also collected as secondary outcomes.
Six individuals withdrew immediately following screening, 2 individuals were excluded during the in-person screening visit, and 17 individuals failed to attend the baseline visit resulting in a final sample of 90 participants (64 women, 26 men).InterventionParticipants were randomly assigned to follow one of two hypocaloric (providing less than estimated calorie needs as determined by the Mifflin-St. At the baseline visit, a registered dietitian reviewed the dietary intervention each participant was randomized to. Members of the study staff and study participants were not able be blinded to the type of diet, though participants received identical interventions and staff attention.
After the initial 16-week weight loss phase both groups entered a 24-week long maintenance phase (for a total of 40 weeks), gradually increasing calorie intake to a maintenance energy level. The FB group was also instructed to take a multivitamin and additional calcium to ensure micronutrient needs were met while following a low-calorie meal plan. Vitamin and mineral fortification of the Medifast meals precluded the need for additional supplementation in the MD group.The Mifflin-St. Jeor equation was used to estimate total daily energy requirements and develop individualized meal plans during the 24-week weight maintenance phase.


The FB group followed meal plans based on USDA Food Guide Pyramid guidelines and their estimated energy needs while the MD group was provided a maintenance meal plan incorporating 3-5 meal replacements, depending on the daily energy requirement of the individual.
Maintenance phase meal plans were reviewed with each participant by a registered dietitian prior to the beginning of the maintenance phase.Physical activity above normal daily activities was not a requirement for participation in the study. While following the 5 & 1 plan, 45 minutes of exercise per day above normal daily activities, is the recommended maximum.
No specific guidelines for physical activity were provided during the weight maintenance phase of the study.Each participant met with a dietitian bi-weekly during the 16-week weight loss phase for dietary and behavioral counseling and at 12 week intervals during the 24 week weight maintenance phase (weeks 28 and 40 of the study, respectively).
Each dietitian had subjects from both groups and reviewed identical information with each subject. Every effort was made to have the subjects see the same dietitian throughout the study; however, it was made clear at screening and throughout the study that an alternate dietitian could be requested for any reason until a suitable match was found. At each visit, all participants were provided a self-study module focusing on a behavioral component of weight loss (e.g. After the study was completed, the FB group had the option of receiving an equivalent amount of meal replacements free of cost or a cash payment of $375.MeasurementsBaseline measures for weight, blood pressure, waist circumference (WC), and body composition [percent body fat, lean muscle mass (LMM) and visceral fat rating (VFR)] were obtained. Bioelectrical impedance (BIA) was used to determine body composition using Tanita's Iron Man BC-549 scale. VFR was determined by an algorithm based on BIA results that generates a rating - the amount of visceral fat itself is not measured.
The range for the VFR is 0-59 with a healthy level of visceral fat receiving a rating of 0-12 and an excess level of visceral fat receiving a rating of 13-59. Weight and blood pressure were measured bi-weekly during the 16-week weight loss phase and at 12 week intervals during the maintenance phase (weeks 28 and 40 of the study, respectively).
WC, pulse, and body composition were measured at weeks 4, 8, 12, 16, 28 and 40.A lipid panel, C-reactive protein (CRP), and urine lipid peroxides (ULP) were measured at baseline, at the end of the weight loss phase (week 16) and at the end of weight maintenance (week 40). CRP was used as a biomarker of inflammation and ULP was used as a biomarker of oxidative stress. Non-parametric tests were used due to the non-normal distribution of the sample's data for most outcome variables.
Random effects regression allows for a subject-specific interpretation, and adjustment for excess between-individual heterogeneity. Where results did not differ between bivariate t-tests and random effects analyses, only t-test results are shown.



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