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

Sponsor:	Medifast, Inc.
Information provided by:	Medifast, Inc.
ClinicalTrials.gov Identifier:	NCT01011491

Purpose

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.

Condition	Intervention
Obesity	Other: Medifast 5 & 1 Plan for weight loss and weight maintenance Other: Food-based diet plan for weight loss and weight maintenance

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance

Resource links provided by NLM:

MedlinePlus related topics: Obesity Weight Control

U.S. FDA Resources

Further study details as provided by Medifast, Inc.:

Primary Outcome Measures:

Weight change (in kilograms) from week 0 [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Satiety using a visual analog scale [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Change in Inflammation represented by C-reactive protein [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Change in Oxidative Stress represented by urine lipid peroxides [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Blood Pressure change [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Change in Pulse [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Change in percent body fat (a measure representing a change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Change in Blood lipids [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Change in lean muscle mass (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Change in Waist circumference (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]
Change in Visceral Fat Rating (a measure representing change in body composition) [ Time Frame: 16 and 40 weeks ] [ Designated as safety issue: No ]

Enrollment:	90
Study Start Date:	March 2008
Study Completion Date:	September 2009
Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Medifast 5 & 1 Plan Medifast's 5 & 1 Plan is a meal replacement plan for weight loss and weight maintenance.	Other: Medifast 5 & 1 Plan for weight loss and weight maintenance 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.
Active Comparator: Food-based 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.	Other: Food-based diet plan for weight loss and weight maintenance 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.

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01011491

Locations

United States, Maryland
Medifast, Inc.
Owings Mills, Maryland, United States, 21117

Sponsors and Collaborators

Medifast, Inc.

Investigators

Principal Investigator:

Lisa M Davis, PhD, PA-C

Medifast, Inc.

More Information

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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.

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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.

Stefanovi? A, Kotur-Stevuljevi? J, Spasi? S, Bogavac-Stanojevi? N, Bujisi? 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. Epub 2007 Sep 11.

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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.

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.

Egger GJ. Are meal replacements an effective clinical tool for weight loss?--a clarification. Med J Aust. 2006 Jun 5;184(11):591. No abstract available.

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.

Responsible Party:	Lisa M. Davis, PhD, PA-C, CNS, LDN/ Vice President, Research & Development, Medifast, Inc.
ClinicalTrials.gov Identifier:	NCT01011491 History of Changes
Other Study ID Numbers:	MED014, 20080292
Study First Received:	November 10, 2009
Last Updated:	November 10, 2009
Health Authority:	United States: Institutional Review Board

Keywords provided by Medifast, Inc.:

Obesity
Weight loss
meal replacements

inflammation
oxidative stress
visceral fat

Additional relevant MeSH terms:

Obesity
Overnutrition
Nutrition Disorders

Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on February 08, 2012