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

Completed · Not applicable

Conditions studied: Obesity

In brief

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.

Key facts

Study ID: NCT01011491
Run by: Medifast, Inc.
People needed: 90
Starts: 2008-03-01
Expected to finish: 2009-09-01
Last updated by the study team: 2009-11-11

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

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

Full record on ClinicalTrials.gov

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