Clinical Studies

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THE SCIENCE BEHIND MEDIFAST

medifast food planAccording to the Academy of Nutrition and Dietetics, “successful weight management to improve overall health for adults requires a lifelong commitment to healthful lifestyle behaviors.” Unfortunately, trying to select nutritious, reduced-calorie foods in our current environment, where tempting, high-calorie, nutrient-poor choices seem to be everywhere, is difficult and can
easily become overwhelming.(1)

That is where Medifast can help. Originally developed by a physician, Medifast Meals are individually portioned, calorie- and carbohydrate-controlled meal replacements. Research has shown the use of meal replacements, as a part of a structured meal plan, is an effective way to lose weight and maintain weight loss over time.(2)

medifastThe scientific and clinical heritage of Medifast is what makes us so unique. Every Medifast Meal shares a similar nutritional “footprint” and provides a balance of protein and good carbohydrates, including fiber. Fortified with vitamins and minerals, these specially formulated products are at the heart of Medifast’s clinically proven program, helping individuals lose weight quickly,
easily, and safely.

Medifast offers a comprehensive approach to weight management: We provide convenient products and structured meal plans for weight loss and maintenance backed by our team of nutrition experts and food scientists, helpful resources, and customer support

 

take shape for life, tsfl, medifast, medifast food, weightloss, weight loss, lose weight, lose weight fast, diet, diet food, weightloss plan, medifast food planMost important, Medifast is supported by research and is clinically proven to be safe and effective for weight loss.

We invite you to read this Medifast Clinical Studies Overview, a compilation of abstracts that include peer-reviewed research of randomized, controlled trials, prospective studies, retrospective reviews, and in-house clinical data. Medifast has been recommended by over 20,000 doctors and used by over one million customers since 1980. We hope you choose Medifast as a key component of your health-related goals, both for successful weight management and as a part of your overall healthful lifestyle behaviors.

 

medifast-FOOD1. Seagle, H.M., Strain, G.W., Makris, A., Reeves, R.S. (2009). Position of the American Dietetic Association: Weight Management. Journal of the American Dietetic Association, 109(2), 330-346.

2. Adult weight management evidence-based nutrition practice guideline. American Dietetic Association Evidence Analysis Library Website. http://www.adaevidencelibrary.com/topic.cfm?cat+2798. Accessed May 13, 2011.

The Science Behind Medifast

The following abstracts include both peer-reviewed research and in-house clinical data.

 

 

A DISTINGUISHED SCIENTIFIC ADVISORY BOARD

In September 2008, Medifast announced the formation of its Scientific Advisory Board.

The role of the Board is to continually review the effectiveness, safety, and nutritional benefits of Medifast’s products and programs. This team of specialists also assists in the development of new Medifast Meals and supplements, as well as weight-loss approaches for specific medical needs (e.g., patients with heart disease) or lifestyles (e.g., vegetarians).

The work of this cross-disciplinary group builds on Medifast’s heritage of medically sound approaches to weight loss and the incorporation of leading-edge clinical research into the company’s products and programs.

vitela-health-medifast-take-shape-for-life-tsfl-tsfl-clinical-studies-weight-loss-studies-weightloss-studies-weight-loss-statistics-weightloss-statistics

 

 

STUDY 1

Davis, L.M., Coleman, C.D., Kiel, J., Rampolla, J., Hutchisen, T., Ford, L., Andersen, W.S., Hanlon-Mitola, A. (2010). Efficacy of a meal replacement diet compared to a food-based diet after a period of weight loss and weight maintenance: a randomized controlled trial. Nutrition Journal, 9(11).

 

OBJECTIVE

To examine the effect of Medifast’s meal replacement program 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 an isocaloric, food-based diet.

 

METHODS

This 40-week randomized, controlled clinical trial included 90 obese adults assigned to one of two weight-loss programs for 16 weeks and then followed for a 24-week period of weight maintenance. Subjects were randomly assigned to two groups: Medifast (MD) (n=45; 30 women, 15 men; BMI 38.5 ± 6.8) and food-based (FB) (n=45; 34 women, 11 men; BMI 37.8 ± 4.5). Subjects met bi-weekly with registered dietitians to have anthropometrics measured and for dietary and behavior counseling during weight loss and every 12 weeks during weight maintenance. Weight and blood pressure were measured bi-weekly during weight loss and every 12 weeks during weight maintenance. Waist circumference, % body fat, lean muscle mass, visceral fat, and pulse were measured every four weeks during weight loss and every 12 weeks during weight maintenance. Biomarkers for inflammation (C-reactive protein), oxidative stress (urine lipid peroxides), and lipid panels were measured at baseline, 16 weeks, and 40 weeks.

 

RESULTS

Weight loss at 16 weeks was significantly better in the MD group versus the FB group (12.3% vs. 6.7%, p=0.001), and overall greater weight loss was achieved on MD at 40 weeks. Significantly more of the MD participants lost ≥5% of their initial weight at week 16 (93% vs. 55%, p=0.002) and week 40 (62% vs. 30%, p=0.034). Significant improvements in body composition were also observed in MD participants compared to FB at week 16 and week 40. Both the MD and FB groups experienced a significant improvement in C-reactive protein (CRP) at week 40. However, when a dichotomous variable was used to characterize baseline CRP levels as low or high, the only sub-group to experience a significant decrease over the 40 weeks was the MD group with high baseline CRP levels (p<0.0001). The MD group experienced a significant decrease in urine lipid peroxides at week 40 (-17.5%, p=0.01) whereas the FB group did not (-5.4%, p=0.84). Additionally, there was a significant mean decrease over time in the MD group (p=0.005) that was not found for the FB group (p=0.84).

 

CONCLUSIONS

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.

 

The 16-week results of this study were presented at Experimental Biology, 2009. The 40-week results
were presented at the Food and Nutrition Conference and Expo, 2009.

 

 

STUDY 2

Cheskin, L.J., Mitchell, A.M., Jhaveri, A.D., Mitola, A.H., Davis, L.M., Lewis, R.A., Yep, M.A., Lycan, T.W. (2008). Efficacy of meal replacements versus a standard food-based diet for weight loss in type 2 diabetes: a controlled clinical trial. The Diabetes Educator, 34(1), 118-127.

 

OBJECTIVE

To compare the efficacy of a portion-controlled meal replacement diet to a standard diet (based on recommendations by the American Diabetes Association) in achieving and maintaining weight loss among obese men and women with type 2 diabetes mellitus.

 

METHODS

This study is a university-based, controlled clinical trial. Participants were 119 men and women with diabetes with a body mass index (BMI) between 25 and 40 kg/m2, assigned randomly to one of two 34-week, 75% of predicted-energy-need diets (portion-controlled (PCD) or standard (SD), self-selected, food-based) and then followed for one year of weight maintenance.

 

RESULTS

Using intention-to-treat analyses, weight loss at 34 weeks and weight maintenance at 86 weeks was significantly better on PCD versus SD. Approximately 40% of the PCD participants lost ≥5% of their initial weight compared with 12% of those on the SD. Significant improvements in biochemical and metabolic measures were observed at 34 weeks in both groups. The retention rate and self-reported ease of adherence in the PCD group were significantly higher throughout the study.Of the 112 participants who began the study, 48 completed the 34-week active weight-loss phase (31 of 54 from the PCD group and 17 of 58 from the SD group: 57.4% vs. 29.3%). After the 34-week active weight-loss phase, weight loss among completers was 6.84% (16.1 ± 13.6 lbs) on the PCD vs. 3.70% (8.1 ± 7.0 lbs) on the SD (p=0.039). Nineteen of 31 (61.3%) PCD participants lost ≥5% of their initial body weight vs. 4 of 17 (23.5%) SD participants (p=0.012). Nine of 31 (29.03%) PCD participants lost ≥10% vs. 1 of 17 (5.88%) SD participants (p=0.059). BMI was significantly reduced in both groups at 34 weeks, but the change in BMI was significantly greater in the PCD group vs. SD group (p=0.015). Significantly more PCD participants were able to reduce their use of medications to control type 2 diabetes after 34 weeks. Of those participants beginning the study using medications for blood glucose control, 7 of 29 (24.1%) PCD participants reduced their use of medications compared to 0 of 13 (0%) SD participants (p=0.0161).

 

CONCLUSIONS

Participants using meal replacements lost twice the amount of weight, experienced less weight regain after one year of maintenance, and were more likely to complete the program than SD participants. As PCDs may help obese patients with type 2 diabetes adhere to a weight-loss program and reduce medication use, health professionals should consider recommending them as part of a comprehensive approach to weight management.

The results of this study were presented at the American Diabetes Association’s 65th Annual Scientific Session, 2005.

 

 

STUDY 3

Haddock, C.K., Poston, W.S.C., Foreyt, J.P., DiBartolomeo, J.J. (2008). Effectiveness of Medifast supplements combined with obesity pharmacotherapy: a clinical program evaluation. Eating and Weight Disorders, 13(2), 95-101.

 

OBJECTIVE

To evaluate the long-term impact of Medifast meal replacement supplements (MMRS) combined with appetite suppressant medication (ASM) among participants who received 52 weeks of treatment as part of a medically
supervised weight-control program.

 

METHODS

This study provides a systematic program evaluation of weight-loss data from a medically supervised weigh tcontrol program combining the use of MMRS and ASM. Data were obtained and analyzed from 1,351 patient (BMI ≥25 kg/m2) medical charts who had participated for at least 12 weeks of treatment. Outcomes included weight loss and percent weight loss from baseline at 12, 24, and 52 weeks. Both completers and intention-to treat (ITT) analyses were conducted. Completers’ (i.e., those with complete data for 52 weeks) outcomes were evaluated after stratification for reported adherence to the MMRS and ASM.

 

RESULTS

Participants who completed 52 weeks of treatment experienced substantial weight loss at 12 (-20.7 ± 12.5 lbs), 24 (-26.4 ± 17.8 lbs), and 52 weeks (27.3 ± 20.2 lbs), and all measures were significantly different from baseline weight (p<0.001 for all contrasts) for both true completers (n=324) and for ITT analysis (n=1,351). Fifty percent of patients remained in the program at 24 weeks and nearly 25% were still participating at one year.

 

CONCLUSIONS

This weight-loss program, using a combination of MMRS and ASM, produced significant and sustained weight loss at 52 weeks. Results were better than those typically reported for obesity pharmacotherapy in both short- and long-term studies and also better than those reported for partial meal replacement programs. Program retention at one year was similar to that reported in many controlled drug trials and better than most commercial programs reported in the literature.

Results of this study were presented at the American Society of Bariatric Physicians’ annual meeting, 2007.

 

 

STUDY 4

Davis, L.M., Coleman, C.D., Andersen, W.S., Cheskin, L.J. (2008). The effect of metabolism-boosting beverages on 24-hr energy expenditure. The Open Nutrition Journal, 2, 37-41.

 

OBJECTIVE

To evaluate the effectiveness of thermogenic meal replacement beverages (TMRB) containing 90 mg of epigallicocatechin gallate (EGCG) and 100 mg of caffeine on resting energy expenditure (REE), fat oxidation, and appetite.

 

METHODS

Thirty adults (19 women and 11 men between the ages of 18 and 65 years) were stratified into three groups: lean (n=10, BMI 21.5 ± 2.1); overweight/obese (OW) (n=10, BMI 29.8 ± 2.7); or weight maintainers (WM) (n=10, BMI 28.8 ± 4.0). WM had maintained a weight loss of ≥5% for at least a three-month period. Following an overnight fast, baseline measurements, including REE via indirect calorimetry, were performed. REE was repeated at 30, 60, 90, and 120 minutes after consuming a TMRB. Appetite was assessed via visual analogue scale at baseline, 30 minutes, and 120 minutes after consuming the TMRB.

 

RESULTS

Mean 24-hour REE was increased 5.9 ± 2.5% overall (p=0.000), 5.7 ± 3.1% among lean subjects (p=0.0002), 5.3 ± 1.4% among OW subjects (p=0.000), and 6.8 ± 2.7% among WM subjects (p=0.0007). Appetite was significantly reduced 30 minutes after consuming the TMRB (p=0.0002). There was an overall trend toward increased fat oxidation with respiratory quotient decreasing from 0.99 ± 0.19 to 0.92 ± 0.13 (p=0.122).

 

CONCLUSIONS

The study results show that ingestion of TMRBs increase resting energy metabolism and decreases appetite. The findings strongly suggest TMRBs are a promising weight-control tool. These decreases in energy intake and increases in energy expenditure may translate into more sustainable weight loss and weight maintenance in both the short and long term.

The results of this study were presented as a poster session at Experimental Biology, 2008.

 

 

STUDY 5

Matalon, V. (2000). An evaluation of weight loss following a carbohydrate and fat restricted diet with appetite suppressant and dietary supplementation. The Bariatrician, Summer, 10-13.

 

OBJECTIVE

To assess the safety and effectiveness of a weight-loss regimen consisting of a carbohydrate- and fat-restricted diet supplemented with an appetite suppressant, a dietary supplement, and a liquid protein drink (Medifast) in an open label trial.

 

METHODS

This six-month open label trial included 47 overweight or obese (BMI ≥25 kg/m2) participants over the age of 18. Participants were seen and evaluated weekly. At each weekly visit, participants were evaluated for total body weight, body composition (% body fat, BMI, lean body mass, water weight), and blood pressure.

 

RESULTS

Of 47 patients enrolled, 24 (51%) completed six months using the dietary regimen prescribed. Data was analyzed for all patients who were treated with the diet, as well as for the subset of patients who completed the entire study period. Baseline and six-month evaluations of body weight (lbs), body fat (%), BMI (kg/m2), lean body mass, water weight, and blood pressure were performed. For completers, at six months, statistically significant differences were found for body weight (-24.9 + 17.9 lbs, p<0.0001), % body fat (-3.9 + 3.4%, p<0.001), BMI (-4.1 + 2.9, p<0.001), and diastolic blood pressure (-6.7 + 11.3 mm Hg, p=0.008). The decreases seen for lean body mass (p=0.06), water weight (p=0.06), and systolic blood pressure (p=0.07) were not significant.

 

CONCLUSIONS

The study demonstrated that a carbohydrate- and fat-restricted program supplemented by a natural appetite suppressant can lead to progressive weight loss of comparable value to prescribed pharmacologic agents at the time of study. Patients experienced statistically significant decreases in overall body weight, percent body fat, BMI, lean body mass, total body water, and both systolic and diastolic blood pressure.

 

 

STUDY 6

Tchernof, A., Starling, R., Turner, A., Shuldiner, A.R., Watson, J.D., Silver, K., Poehlman, E.T. (2000). Impaired capacity to lose visceral adipose tissue during weight reduction in obese postmenopausal women with the Trp64Arg beta3-adrenoceptor gene variant. Diabetes, 49, 1709-1713.

OBJECTIVE

To examine the effect of the Trp64Arg gene variant on total and visceral adipose tissue loss, and cardiovascular risk factors in response to weight reduction among 24 obese women (age 57 ± four years) in a 13 ± three-month weight-reduction program of 1,200 kcal with or without the inclusion of Medifast.

 

METHODS

Obese, postmenopausal Caucasian women in the greater Burlington, Vermont, area were recruited by local advertisement. A total of 491 obese women were screened, of which 38 were heterozygotes for the Trp64Arg variant (allele frequency 0.10). Of this initial cohort, 24 obese women (one Arg64Arg homozygote, 10 Trp64Arg heterozygotes, and 13 normal homozygotes) completed the weight-loss program.

 

RESULTS

No baseline differences were noted in adiposity measurements, glucose disposal, and lipid profiles among carriers and noncarriers of the variant allele. Whether women were carriers or noncarriers of the Trp64Arg allele, significant weight loss (-36.1 ± 11.0 lbs vs. -31.0 ± 13.6 lbs, NS) and reductions in body fat (-22.0 ± 11.4 lbs vs. -25.3 ± 8.6 lbs, NS) were observed in response to a calorie-restricted program with or without Medifast. However, loss of visceral adipose tissue was 43% lower in carriers of the Trp64Arg allele compared with noncarriers (-46 ± 27 vs. -81 ± 51 cm2, p=0.05). Furthermore, there was less improvement in the total cholesterol-to-HDL cholesterol ratio (-0.18 ± 0.54 vs. -0.72 ± 0.56, p=0.04) in carriers compared with noncarriers of the allele. Although glucose disposal improved in both groups, there was no difference in the magnitude of improvement between carriers and noncarriers of the variant allele.

 

CONCLUSIONS

Older women carrying the Trp64Arg B3-adrenoceptor gene variant have an impaired capacity to lose visceral adipose tissue in response to a calorie-restricted diet.

 

 

STUDY 7

Coleman, C., Kiel, J., Davis, L.M., Mitola, A., Sonzone, C., (2012) Use of the Medifast meal replacement program for weight loss in overweight and obese clients: A retrospective chart review of three Medifast Weight Control Centers (MWCC). FASEB J. 26, lb327

 

OBJECTIVE

A chart review was performed to evaluate the effectiveness of the Medifast meal replacement plan (MD) on
body weight and body composition at 4, 12, 24 weeks (wk), and final weight-loss visit (19.6 ± 13.5 wk) (FV) at 3
MWCCs for the years 2007-10.

 

METHODS

Charts included adults aged 18-70 following MD with a BMI ≥25 kg/m2 that signed a health information consent form. 446 charts (males n=60 (13.5%); females n= 386 (86.5%)) were included. Data were collected electronically and included weight (Wt), systolic and diastolic blood pressure (SBP, DBP), lean muscle mass (LMM), body fat mass (BFM), % body fat (%BF), and abdominal circumference (AC). Additional data collected included: demographics, side effects, and compliance.

 

RESULTS

Significant improvements (p<0.0001) were seen at all time-points: wk 4, 12, 24, and FV. Wt loss: -12.7, -26.3, -38.2, -25.7 lbs; % Wt loss: -6.0, -12.1, -17.0, -12.3%; %BF: -2.2, -5.2, -8.5, -6.6; BFM: -10.1, -20.1, -31.6, -23.5 lbs; AC: -2.2, -4.0, -6.0, -4.7 in; SBP: -8.0, -8.6, -15.6, -8.8 mmHG; DBP: -5.3, -6.4, -9.2, -6.0 mmHG. % total body weight that was LMM improved by 3.5, 9.8, 16.0, and 13.9% (P<0.0001) respectively.

 

CONCLUSIONS

Medifast’s meal replacement plan, along with the support and accountability available in the MWCC, is an efficacious model that promotes significant weight loss and improvements in body composition.

The results of this study were presented as a poster session at Experimental Biology, 2012.

 

STUDY 8

Kiel, J., Coleman, C., Mitola, A., Sonzone, C., Davis, L.M., (2012) The impact of compliance on the effectiveness of the Medifast meal replacement program for weight loss in overweight and obese clients: A retrospective chart review of three Medifast Weight Control Centers (MWCC). FASEB J. 26, lb398.

 

OBJECTIVE

A chart review was performed to evaluate the association between compliance and the effectiveness of the Medifast meal replacement plan (MD) on body weight from baseline to final weight-loss visit (FV) at three Medifast Weight Control Centers (MWCC) for the years 2007-10.

 

METHODS

Charts included adults aged 18-70 following the MD with a BMI ≥25 kg/m2 that signed a health information consent form. 446 charts were included. Compliance included attendance at weekly visits (WV), intake of meal replacements (MR) and supplements (omega-3), food journals (FJ), and ketone testing (KT).

 

RESULTS

53% of clients attended a WV for their entire prescribed program. When clients attended, the average compliance for MR=70%, omega-3=76%, FJ=53% and KT=96%. There is significant correlation between all the compliance factors with the strongest relationships between WV, MR, and FJ (p<0.01). Bivariate random effects (RE) regressions showed significant (p<0.05) inverse relationships between wt Δ and WV, MR, FJ and omega-3. Multivariate RE analysis showed sustained significant (p<0.05) relationships between wt Δ and WV (β= -41.5), MR (β= -1.3) and KT (β= 2.9) (R2=0.22, Wald Chi2 (df=3) 148, p<0.0001).

 

CONCLUSIONS

Taken together, these results reveal significant associations between several components of compliance and weight loss, but particularly highlight the importance of attendance at weekly visits, a benefit of the MWCC model over non-clinic based models.

The results of this study were presented as a poster session at Experimental Biology, 2012.

 

STUDY 9

Yuh, J., Debrakeleer, D., McIntyre, W., Coleman C., Fox L., Barmat, L. (2011). Efficacy of a hypocaloric weight management program in obese women with polycystic ovarian syndrome (PCOS) [abstract]. 9th Annual Meeting of Androgen Excess & PCOS Society; 2011 Oct 13 – 15, Abstract nr 21.

 

OBJECTIVE

To evaluate the efficacy of a hypocaloric diet program utilizing a health coach on body weight and changes in biochemical and metabolic profiles in obese PCOS patients.

 

METHODS

This was a prospective study conducted in a teaching community hospital. Subjects were obese (BMI 33.1 ± 3.0), adult, non-pregnant women, ages 20-39 (27.7 ± 6.1), with PCOS defined by Rotterdam criteria. Subjects were eligible if they were free of hormonal medications for ≥3 months, were non-smokers, and did not have diabetes or hypertension. For three months, patients followed a 1000-calorie diet plan with the guidance of a health coach, consisting of five Medifast meals and one self-prepared meal. Meetings with the health coach, weight measurement, and lab draws occurred on a monthly basis. The primary outcome was change in body weight; secondary outcomes were biochemical and metabolic changes. Paired t-tests were used to examine the longitudinal changes from baseline. Significance was defined as p<0.05.

RESULTS

Eleven subjects completed the study. The hypocaloric diet resulted in significant decline in body weight (-18.2 ± 6.85 lbs; p<0.0001), two-hour oral glucose (-23.0 ± 22.4 mg/dl; p=0.010), two-hour insulin (-79.1 ± 76.6 ųIU/ml; p=0.022), and calculated free androgen index (-3.7 ± 2.54; p=0.017). There was a marginally significant increase in SHGB (+9.2 ± 14.1 nmol/L; p=0.069). For subjects with elevated levels at baseline, significant improvements were found in total cholesterol (-37.0 ± 13.90 mg/dl; p=0.013), LDL cholesterol (-28.0 ± 10.80 mg/dl; p=0.014), and triglycerides (-90.0 ± 1.41 mg/dl; p=0.007). Overall, one-third of previously an ovulatory women began ovulating and seven out of 11 began regular menstruation.

 

CONCLUSIONS

Significant improvements in body weight and biochemical and metabolic markers were achieved in obese PCOS subjects after three months following a hypocaloric, portion-controlled diet plan under the guidance of a health coach, making conditions more favorable for ovulation.

The results of this study were presented at the 9th Annual Meeting of Androgen Excess & PCOS Society, 2011.

 

STUDY 10

Cheskin, L.J., Hanlon-Mitola, A., Mitchell, A., Jhaveri, A., Yep, M., Mitchell, V. (2007). A RCT comparing balanced energy deficit diets with or without meal replacements for weight loss and maintenance among children dieting alone or with a parent. The Journal of the Federation of American Societies for Experimental Biology, 21, lb214.

 

OBJECTIVE

To compare the safety and efficacy of supplemental Medifast portion-controlled meal replacements (MR) to a USDA Food Guide Pyramid-based diet (USDA) among children dieting alone or with a parent.

 

METHODS

This 18-month randomized, controlled trial included 80 overweight (BMI > 95th percentile on BMI-for-age growth charts) boys and girls between the ages of eight and 15 years and 40 parents randomly assigned to one of two weight-loss programs for six months and then followed for a 12-month period of weight maintenance. Subjects were further randomized to dieting alone or with a parent. Both weight-loss diets (MR and USDA) were 20% energy-restricted (~500 kcal deficit). Those randomized to the MR diet incorporated three MRs/d during the active weight-loss phase and two MRs/d during the maintenance phase. Participants reported to the research clinic every other week to weigh in, attend educational group sessions, and receive MRs.

 

RESULTS

By ITT analysis, dieting alone vs. with a parent or USDA vs. MR made no difference in weight outcome. However, following initial weight loss (six months) and one year maintenance (18 months), significant (p<0.05) decreases were seen in the MR group in BMI%ile (zero months=98.8 ± 1.06, six months=96.6 ± 3.2, 18 months=96.4 ± 3.4); body fat (5.9% at six months, 5.3% at 18 months); total cholesterol (6.7% at six months, 5.6% at 18 months); LDL (19.8% at six months, 7.9% at 18 months); and triglycerides (23.6% at six months, 22.3% at 18 months). Although not found to be significant, drop-out rates were higher in the USDA group (43.6%, 35.9%, 10.25%) vs. the MR group (59.0%, 48.7%, 15.4%) at 12 weeks, six months, and 18 months, respectively. No significant between-group differences, differences in growth rates, or adverse events were observed.

 

CONCLUSIONS

Among overweight 8 to 15 year-old children, dieting with or without a parent, meal replacements were as safe and effective as a USDA food-based diet for weight loss and maintenance. Similar results were also seen with other anthropometrics studied. Dieting with a parent made no difference in weight outcomes. It was determined from these data that an MR diet in children was both safe and efficacious. The safety of a MR diet in children was determined by the absence of adverse events in the children during the entire 18-month period of the study.

The results of this study were presented at Experimental Biology, 2007.

 

STUDY 11

Davis, L.M., Cheskin, L.J. (2006). Dietary intervention using Medifast meal replacements in prebariatric surgery patients: A statistical review of patient charts. Unpublished Data on File.

 

OBJECTIVE

To evaluate the efficacy of a dietary intervention that included a reduced-calorie meal plan utilizing Medifast meal replacements, behavior counseling, and physical activity at achieving weight loss in low-income prebariatric surgery patients.

 

METHODS

14 severely obese patients—13 females (11 African Americans, two Caucasians) and one male (Caucasian)—with a mean BMI of 64.14 kg/m2 (range 40.2 kg/m2 to 91.7 kg/m2) entered a six-month weight-control program at the Johns Hopkins Weight Management Center. All patients were Medicaid recipients. The program provided a comprehensive approach to weight control focused on diet, behavior, and physical activity. Portion-controlled meal replacements supplied by Medifast were utilized as part of the dietary-behavior intervention. All subjects met with a licensed dietitian and were prescribed a 1,000-1,200 kcal/day diet plan incorporating up to six MRs/day. Only one subject chose not to incorporate meal replacements as part of a low-calorie diet plan. The average intake of meal replacements was 2.5-3 per day through the duration of the study

 

RESULTS

After six months on the program, patients lost an average of 26.73 lbs (-2.86 kg/m2) and 6.96% of their body weight. A high level of satisfaction was reported with their diet plan. Program completers at one month were n=13, at three months n=12, and six months n=10.

 

CONCLUSIONS

Bariatric surgical candidates who enter weight-control programs to lose weight pre-operatively have been shown to have lower rates of morbidity and mortality. We have demonstrated that use of meal replacements pre-operatively is effective at achieving significant weight loss, and can thus be expected to improve immediate and longer-term results in bariatric surgery patients.

A statistical review of patient charts. Unpublished data on file, 2006.

 

STUDY 12

Crowell, M.D., Cheskin, L.J., Musial, F. (1993). Multicenter evaluation of health benefits and weight loss on the Medifast weight management program: a statistical review of patient charts. Unpublished Data on File.

 

OBJECTIVE

To retrospectively evaluate the efficacy of a medically supervised, protein-supplemented modified program (Medifast) for weight reduction and to evaluate the impact of weight reduction on coexisting health problems.

 

METHODS

This study provides a systematic evaluation of weight-loss data randomly selected from a medically supervised weight-control center. Data were obtained and analyzed from patient medical charts that had completed at least 16 weeks of the program. Outcomes included weight loss, blood pressure, and blood lipids.

 

RESULTS

The combined sample lost an average of 49.5 ± 24.2 lbs and were in the program an average of 21.3 ± 7.7 weeks. Males lost an average of 64.8 ± 29.2 lbs and females lost an average of 47.3 ± 22.5 lbs. The study found significant reductions in total cholesterol and triglycerides, systolic and diastolic blood pressure, and normalized blood pressure in hypertensive patients.

 

CONCLUSIONS

Medically supervised, protein-sparing, meal replacement programs offer a safe and effective means of weight reduction and are accompanied by significant improvements in coexisting health problems.

A statistical review of patient charts. Unpublished data on file, 1993.