Clinical research using Medifast protocols and products

Clinical Study 2

REFERENCE: Cheskin, Lawrence J.; Davis, Lisa M.; Hanlon-Mitola, Andrea; Mitchell, Amy; Jhaveri,Ami; Mary, Yep; Mitchell, Vanessa. Johns Hopkins Bloomberg School of Public Health, Center for Human Nutrition, Department of International Health, Baltimore, MD 21205. “Efficacy of Parent-Child Dieting Plans Incorporating Medifast Meal Replacements for Weight Loss. RCT Comparing Balanced Energy Deficit Diets With or Without Meal Replacements for Weight Loss and Maintenance Among Children Dieting Alone or With a Parent.”

PURPOSE: To compare the safety and efficacy of supplemental Medifast portion-controlled meal replacements (MRs) with a USDA Food Guide Pyramid-based diet. Both weight loss diets were 20% energy-restricted (~500 kcal deficit). Eighty, 8-15 yo children, BMI>95th%ile, were screened and 40 randomized to either a MR diet (3 MRs/d during active weight loss and 2 MRs/d during maintenance) or to the food-based diet. Subjects were further randomized to dieting alone or with a parent.

RESULTS: By ITT analysis, dieting with a parent vs. without or food vs MR, made no difference in weight outcome. However, following initial weight loss (6 mos) and 1 yr maintenance (18 mos), significant (p less than or equal to 0.05) benefits were seen in the MR group in BMI%ile (0 mos=98.8 ± 1.0, 6 mos=96.6 ± 3.2, 18 mos=96.4 ± 3.4); body fat (?5.9%@ 6 mos, 5.3% @ 18 mos), total cholesterol (?6.7%, 5.6%), LDL (?19.8%, 7.9%) and triglycerides (?23.6%, 22.3%). No significant between-group differences, differences in growth rates, or adverse events were observed. Conclusions: Among overweight 8-15 yo children, dieting with or without a parent, meal replacements were as safe and effective as a food-based diet for weight loss and maintenance. (Supported by Medifast Inc., MD)

Clinical Study 2

REFERENCE: Haddock, C.K.; Poston, W.S.C.; Foreyt, J.P.; DiBartolomeo, J.J.; and Warner, P.O. “Effectiveness of Medifast Supplements Combined with Obesity Pharmacotherapy: A Clinical Program Evaluation.”

PURPOSE: The purpose of the study is to evaluate the long-term impact of Medifast meal-replacement supplements combined with appetite suppressant medication (ASM) among participants who received a minimum of 12-weeks of treatment.

RESULTS: Participants who completed 52 weeks of treatment experienced substantial weight losses at 12 weeks (-9.4 ± 5.7 kg), 24 weeks (-12.0 ± 8.1 kg), and 52 weeks (12.4 ± 9.2 kg), and all measures were significantly different from baseline weight (0.001 for all contrasts) for both true completers (n=34) and for ITT analysis (n=1,351). Fifty percent of patients remained in the program at 24 weeks and nearly 25% were still participating after one year. This weight-loss program using a combination of MMRS and ASM produced significant and sustained weight losses at 52 weeks. Results are better than those typically reported for obesity pharmacotheraphy in both short- and long-term studies, and are 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 study.

Clinical Study 2

REFERENCE: National Institutes of Health. “Impaired Capacity to Lose Visceral Adipose Tissue During Weight Reduction in Obese Postmenopausal Women With the Trp64Arg B3- Adrenoceptor Gene Variant.”

PURPOSE: To examine whether women on a weight loss program who are carriers of a genetic variant (Trp64Arg) lose less visceral fat than women who do not have this gene. Participants entered a medically supervised weight loss program aimed at reducing body weight to less than 120% of ideal value. Food was self selected with dietitian supervision, with or without the inclusion of TakeShapeTM, a Medifast brand modified fasting supplement.

RESULTS: Reductions in body weight, BMI, total fat mass and fat-free mass were not significantly different between carriers and non-carriers of the variant. Both groups experienced weight reduction of 31-36.1 pounds, which the study identified as a significant weight-loss effect.

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