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Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories

Primary Purpose

Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Medifast 5 & 1 Plan for weight loss and weight maintenance
Food-based diet plan for weight loss and weight maintenance
Sponsored by
Medifast, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Weight loss, meal replacements, inflammation, oxidative stress, visceral fat

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult males and females (age between 18 and 65)
  • Obese (BMI >=30.0 kg/m2 and <50.0 kg/m2)
  • Non-smokers
  • No known food allergies to wheat, gluten, soy or nuts
  • <14 alcoholic beverages per week
  • Willing and able to give informed consent
  • Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin)
  • Not pregnant or lactating
  • Primary care physician's permission for weight loss, normal labs and electrocardiogram (EKG) within past 1 year

Exclusion Criteria:

  • Actively dieting
  • Eating Attitudes Test (EAT) > 30
  • Chronic uncontrolled health problems (not including obesity or diabetes)
  • Pacemaker or other internal electronic medical device
  • Schizophrenia, history of bipolar disorder, current Major Depressive Disorder
  • Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines)
  • Cognitive impairment severe enough to preclude informed consent
  • Taking weight loss or appetite-suppressant medications
  • Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin)
  • Food allergies to wheat, gluten, soy, or nuts
  • Pregnant or lactating

Sites / Locations

  • Medifast, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Medifast 5 & 1 Plan

Food-based

Arm Description

Medifast's 5 & 1 Plan is a meal replacement plan for weight loss and weight maintenance.

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.

Outcomes

Primary Outcome Measures

Weight change (in kilograms) from week 0

Secondary Outcome Measures

Satiety using a visual analog scale
Change in Inflammation represented by C-reactive protein
Change in Oxidative Stress represented by urine lipid peroxides
Blood Pressure change
Change in Pulse
Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms)
Change in percent body fat (a measure representing a change in body composition)
Change in Blood lipids
Change in lean muscle mass (a measure representing change in body composition)
Change in Waist circumference (a measure representing change in body composition)
Change in Visceral Fat Rating (a measure representing change in body composition)

Full Information

First Posted
November 10, 2009
Last Updated
November 10, 2009
Sponsor
Medifast, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01011491
Brief Title
Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories
Official Title
Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance
Study Type
Interventional

2. Study Status

Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medifast, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
Obesity, Weight loss, meal replacements, inflammation, oxidative stress, visceral fat

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Medifast 5 & 1 Plan
Arm Type
Experimental
Arm Description
Medifast's 5 & 1 Plan is a meal replacement plan for weight loss and weight maintenance.
Arm Title
Food-based
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Medifast 5 & 1 Plan for weight loss and weight maintenance
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Food-based diet plan for weight loss and weight maintenance
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight change (in kilograms) from week 0
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Satiety using a visual analog scale
Time Frame
16 weeks
Title
Change in Inflammation represented by C-reactive protein
Time Frame
16 and 40 weeks
Title
Change in Oxidative Stress represented by urine lipid peroxides
Time Frame
16 and 40 weeks
Title
Blood Pressure change
Time Frame
16 and 40 weeks
Title
Change in Pulse
Time Frame
16 and 40 weeks
Title
Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms)
Time Frame
24 weeks
Title
Change in percent body fat (a measure representing a change in body composition)
Time Frame
16 and 40 weeks
Title
Change in Blood lipids
Time Frame
16 and 40 weeks
Title
Change in lean muscle mass (a measure representing change in body composition)
Time Frame
16 and 40 weeks
Title
Change in Waist circumference (a measure representing change in body composition)
Time Frame
16 and 40 weeks
Title
Change in Visceral Fat Rating (a measure representing change in body composition)
Time Frame
16 and 40 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Adult males and females (age between 18 and 65) Obese (BMI >=30.0 kg/m2 and <50.0 kg/m2) Non-smokers No known food allergies to wheat, gluten, soy or nuts <14 alcoholic beverages per week Willing and able to give informed consent Not currently using appetite-affecting medications (e.g SSRIs, steroids, Ritalin) Not pregnant or lactating Primary care physician's permission for weight loss, normal labs and electrocardiogram (EKG) within past 1 year Exclusion Criteria: Actively dieting Eating Attitudes Test (EAT) > 30 Chronic uncontrolled health problems (not including obesity or diabetes) Pacemaker or other internal electronic medical device Schizophrenia, history of bipolar disorder, current Major Depressive Disorder Dependence on alcohol or sedative-hypnotic drugs (e.g. benzodiazepines) Cognitive impairment severe enough to preclude informed consent Taking weight loss or appetite-suppressant medications Taking appetite affecting medications (e.g. SSRIs, steroids, Ritalin) Food allergies to wheat, gluten, soy, or nuts Pregnant or lactating
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lisa M Davis, PhD, PA-C
Organizational Affiliation
Medifast, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medifast, Inc.
City
Owings Mills
State/Province
Maryland
ZIP/Postal Code
21117
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
14711072
Citation
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.
Results Reference
background
PubMed Identifier
15199035
Citation
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.
Results Reference
background
PubMed Identifier
14747663
Citation
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.
Results Reference
background
PubMed Identifier
11814453
Citation
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.
Results Reference
background
PubMed Identifier
14969505
Citation
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.
Results Reference
background
PubMed Identifier
12370461
Citation
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.
Results Reference
background
PubMed Identifier
12704397
Citation
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.
Results Reference
background
PubMed Identifier
10591334
Citation
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.
Results Reference
background
PubMed Identifier
10195925
Citation
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.
Results Reference
background
PubMed Identifier
11827920
Citation
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.
Results Reference
background
PubMed Identifier
15599400
Citation
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.
Results Reference
background
PubMed Identifier
17850913
Citation
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.
Results Reference
background
PubMed Identifier
15126709
Citation
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.
Results Reference
background
PubMed Identifier
17592648
Citation
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.
Results Reference
background
PubMed Identifier
11707555
Citation
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.
Results Reference
background
PubMed Identifier
16768675
Citation
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.
Results Reference
background
PubMed Identifier
12612226
Citation
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.
Results Reference
background
PubMed Identifier
20222968
Citation
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.
Results Reference
derived

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Comparison of Medifast's 5 & 1 Plan to a Food-based Plan of Equal Calories

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