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

Information source: Medifast, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity

Intervention: Medifast 5 & 1 Plan for weight loss and weight maintenance (Other); Food-based diet plan for weight loss and weight maintenance (Other)

Phase: N/A

Status: Completed

Sponsored by: Medifast, Inc.

Official(s) and/or principal investigator(s):
Lisa M Davis, PhD, PA-C, Principal Investigator, Affiliation: Medifast, Inc.

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.

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Weight change (in kilograms) from week 0

Secondary outcome:

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)

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

Related publications:

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Starting date: March 2008
Last updated: November 10, 2009

Page last updated: August 23, 2015

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