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

NCT01011491 | Completed

• 2 other identifiers: MED01420080292
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

Obesity; Weight loss; meal replacements; inflammation; oxidative stress; visceral fat

Outcome Measures

Primary Outcomes (1)

• Weight change (in kilograms) from week 0

  16 weeks

Secondary Outcomes (11)

• 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

  16 and 40 weeks

• Blood Pressure change

  16 and 40 weeks

• Change in Pulse

  16 and 40 weeks

Study Arms (2)

Medifast 5 & 1 Plan

EXPERIMENTAL

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

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.

Other: Food-based diet plan for weight loss and weight maintenance

Interventions

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.

Medifast 5 & 1 Plan

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.

Food-based

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medifast, Inc.: lead

Study Sites (1)

Medifast, Inc.

Owings Mills, Maryland, 21117, United States

Location

Related Publications (18)

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  PMID: 12370461 BACKGROUND

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  PMID: 12704397 BACKGROUND

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  PMID: 10591334 BACKGROUND

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  PMID: 10195925 BACKGROUND

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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. doi: 10.1172/JCI21625.

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  PMID: 15126709 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.

  PMID: 17592648 BACKGROUND

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• 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.

  PMID: 16768675 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.

  PMID: 12612226 BACKGROUND

• 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.

  PMID: 20222968 DERIVED

MeSH Terms

Conditions

Obesity; Weight Loss; Inflammation

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes; Pathologic Processes

Study Officials

• Lisa M Davis, PhD, PA-C

  Medifast, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 10, 2009
• First Posted: November 11, 2009
• Study Start: March 1, 2008
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: November 11, 2009

Record last verified: 2009-11

Locations

US (1)