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| ID | Type | Description | Link |
|---|---|---|---|
| 20080292 | Other Identifier | Western Institutional Review Board |
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Portion-controlled meal replacements have been shown to be an effective weight control strategy in overweight and obese individuals. Thus, the investigators plan to evaluate the effect of Medifast's 5 & 1 program compared to an food-based diet plan of equal calories on the following indices: weight loss and maintenance of weight loss, satiety during weight loss, changes in biochemical markers of inflammation and oxidative stress following weight loss, and compliance and retention rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medifast 5 & 1 Plan | Experimental | Medifast's 5 & 1 Plan is a meal replacement plan for weight loss and weight maintenance. |
|
| Food-based | Active Comparator | The food-based arm followed a meal plan of self-selected foods that provided the same number of calories as the Medifast 5 & 1 plan. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medifast 5 & 1 Plan for weight loss and weight maintenance | Other | Medifast's 5 & 1 Plan is a meal replacement program for weight loss that uses 5 Medifast meals and 1 self-prepared meal. The weight maintenance plan incorporates 3-5 Medifast meals as well as a certain amount of food from all other food groups. |
| Measure | Description | Time Frame |
|---|---|---|
| Weight change (in kilograms) from week 0 | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Satiety using a visual analog scale | 16 weeks | |
| Change in Inflammation represented by C-reactive protein | 16 and 40 weeks | |
| Change in Oxidative Stress represented by urine lipid peroxides |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa M Davis, PhD, PA-C | Medifast, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medifast, Inc. | Owings Mills | Maryland | 21117 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14711072 | Background | Thearle M, Aronne LJ. Obesity and pharmacologic therapy. Endocrinol Metab Clin North Am. 2003 Dec;32(4):1005-24. doi: 10.1016/s0889-8529(03)00066-5. | |
| 15199035 | Background | Hedley AA, Ogden CL, Johnson CL, Carroll MD, Curtin LR, Flegal KM. Prevalence of overweight and obesity among US children, adolescents, and adults, 1999-2002. JAMA. 2004 Jun 16;291(23):2847-50. doi: 10.1001/jama.291.23.2847. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| Food-based diet plan for weight loss and weight maintenance | Other | The food-based group was provided a meal plan for weight loss based on the guidelines of the USDA Food Guide Pyramid providing the same number of calories as the Medifast 5 & 1 Plan. Weight maintenance calories were calculated and participants were provided meal plans from the USDA Food Guide Pyramid. |
|
| 16 and 40 weeks |
| Blood Pressure change | 16 and 40 weeks |
| Change in Pulse | 16 and 40 weeks |
| Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms) | 24 weeks |
| Change in percent body fat (a measure representing a change in body composition) | 16 and 40 weeks |
| Change in Blood lipids | 16 and 40 weeks |
| Change in lean muscle mass (a measure representing change in body composition) | 16 and 40 weeks |
| Change in Waist circumference (a measure representing change in body composition) | 16 and 40 weeks |
| Change in Visceral Fat Rating (a measure representing change in body composition) | 16 and 40 weeks |
| 14747663 | Background | Gale SM, Castracane VD, Mantzoros CS. Energy homeostasis, obesity and eating disorders: recent advances in endocrinology. J Nutr. 2004 Feb;134(2):295-8. doi: 10.1093/jn/134.2.295. |
| 11814453 | Background | de Ferranti S, Rifai N. C-reactive protein and cardiovascular disease: a review of risk prediction and interventions. Clin Chim Acta. 2002 Mar;317(1-2):1-15. doi: 10.1016/s0009-8981(01)00797-5. |
| 14969505 | Background | Festi D, Colecchia A, Sacco T, Bondi M, Roda E, Marchesini G. Hepatic steatosis in obese patients: clinical aspects and prognostic significance. Obes Rev. 2004 Feb;5(1):27-42. doi: 10.1111/j.1467-789x.2004.00126.x. |
| 12370461 | Background | Abbott RD, Ross GW, White LR, Nelson JS, Masaki KH, Tanner CM, Curb JD, Blanchette PL, Popper JS, Petrovitch H. Midlife adiposity and the future risk of Parkinson's disease. Neurology. 2002 Oct 8;59(7):1051-7. doi: 10.1212/wnl.59.7.1051. |
| 12704397 | Background | Heymsfield SB, van Mierlo CA, van der Knaap HC, Heo M, Frier HI. Weight management using a meal replacement strategy: meta and pooling analysis from six studies. Int J Obes Relat Metab Disord. 2003 May;27(5):537-49. doi: 10.1038/sj.ijo.0802258. |
| 10591334 | Background | Visser M, Bouter LM, McQuillan GM, Wener MH, Harris TB. Elevated C-reactive protein levels in overweight and obese adults. JAMA. 1999 Dec 8;282(22):2131-5. doi: 10.1001/jama.282.22.2131. |
| 10195925 | Background | Yudkin JS, Stehouwer CD, Emeis JJ, Coppack SW. C-reactive protein in healthy subjects: associations with obesity, insulin resistance, and endothelial dysfunction: a potential role for cytokines originating from adipose tissue? Arterioscler Thromb Vasc Biol. 1999 Apr;19(4):972-8. doi: 10.1161/01.atv.19.4.972. |
| 11827920 | Background | Tchernof A, Nolan A, Sites CK, Ades PA, Poehlman ET. Weight loss reduces C-reactive protein levels in obese postmenopausal women. Circulation. 2002 Feb 5;105(5):564-9. doi: 10.1161/hc0502.103331. |
| 15599400 | Background | Furukawa S, Fujita T, Shimabukuro M, Iwaki M, Yamada Y, Nakajima Y, Nakayama O, Makishima M, Matsuda M, Shimomura I. Increased oxidative stress in obesity and its impact on metabolic syndrome. J Clin Invest. 2004 Dec;114(12):1752-61. doi: 10.1172/JCI21625. |
| 17850913 | Background | Stefanovic A, Kotur-Stevuljevic J, Spasic S, Bogavac-Stanojevic N, Bujisic N. The influence of obesity on the oxidative stress status and the concentration of leptin in type 2 diabetes mellitus patients. Diabetes Res Clin Pract. 2008 Jan;79(1):156-63. doi: 10.1016/j.diabres.2007.07.019. Epub 2007 Sep 11. |
| 15126709 | Background | Vincent HK, Morgan JW, Vincent KR. Obesity exacerbates oxidative stress levels after acute exercise. Med Sci Sports Exerc. 2004 May;36(5):772-9. doi: 10.1249/01.mss.0000126576.53038.e9. |
| 17592648 | Background | Ashley JM, Herzog H, Clodfelter S, Bovee V, Schrage J, Pritsos C. Nutrient adequacy during weight loss interventions: a randomized study in women comparing the dietary intake in a meal replacement group with a traditional food group. Nutr J. 2007 Jun 25;6:12. doi: 10.1186/1475-2891-6-12. |
| 11707555 | Background | Ditschuneit HH, Flechtner-Mors M. Value of structured meals for weight management: risk factors and long-term weight maintenance. Obes Res. 2001 Nov;9 Suppl 4:284S-289S. doi: 10.1038/oby.2001.132. |
| 16768675 | Background | Egger GJ. Are meal replacements an effective clinical tool for weight loss?--a clarification. Med J Aust. 2006 Jun 5;184(11):591. doi: 10.5694/j.1326-5377.2006.tb00399.x. No abstract available. |
| 12612226 | Background | Ball SD, Keller KR, Moyer-Mileur LJ, Ding YW, Donaldson D, Jackson WD. Prolongation of satiety after low versus moderately high glycemic index meals in obese adolescents. Pediatrics. 2003 Mar;111(3):488-94. doi: 10.1542/peds.111.3.488. |
| 20222968 | Derived | Davis LM, Coleman C, Kiel J, Rampolla J, Hutchisen T, Ford L, Andersen WS, Hanlon-Mitola A. Efficacy of a meal replacement diet plan compared to a food-based diet plan after a period of weight loss and weight maintenance: a randomized controlled trial. Nutr J. 2010 Mar 11;9:11. doi: 10.1186/1475-2891-9-11. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D010335 | Pathologic Processes |