Clinical trial NCT01011491: 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
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Obesity
Weight loss
meal replacements
inflammation
oxidative stress
visceral fat
Lead sponsor: Medifast, Inc.
Sponsor class: INDUSTRY
First posted: 2009-11-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Weight change (in kilograms) from week 0
timeFrame: 16 weeks
Secondary outcomes:
measure: Satiety using a visual analog scale
timeFrame: 16 weeks
measure: Change in Inflammation represented by C-reactive protein
timeFrame: 16 and 40 weeks
measure: Change in Oxidative Stress represented by urine lipid peroxides
timeFrame: 16 and 40 weeks
measure: Blood Pressure change
timeFrame: 16 and 40 weeks
measure: Change in Pulse
timeFrame: 16 and 40 weeks
measure: Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms)
timeFrame: 24 weeks
measure: Change in percent body fat (a measure representing a change in body composition)
timeFrame: 16 and 40 weeks
measure: Change in Blood lipids
timeFrame: 16 and 40 weeks
measure: Change in lean muscle mass (a measure representing change in body composition)
timeFrame: 16 and 40 weeks
measure: Change in Waist circumference (a measure representing change in body composition)
timeFrame: 16 and 40 weeks
measure: Change in Visceral Fat Rating (a measure representing change in body composition)
timeFrame: 16 and 40 weeks
Other outcomes:
Locations:
city: Owings Mills
country: United States
facility: Medifast, Inc.
state: Maryland
Study officials:
affiliation: Medifast, Inc.
name: Lisa M Davis, PhD, PA-C
role: PRINCIPAL_INVESTIGATOR
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