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Completed

NCT Number: NCT01011491

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

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.

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Key information

Conditions

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

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Medifast, Inc.

Owings Mills, Maryland, 21117, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Weight change (in kilograms) from week 0

    Time frame: 16 weeks

Secondary outcomes

  1. Satiety using a visual analog scale

    Time frame: 16 weeks

  2. Change in Inflammation represented by C-reactive protein

    Time frame: 16 and 40 weeks

  3. Change in Oxidative Stress represented by urine lipid peroxides

    Time frame: 16 and 40 weeks

  4. Blood Pressure change

    Time frame: 16 and 40 weeks

  5. Change in Pulse

    Time frame: 16 and 40 weeks

  6. 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

  7. Change in percent body fat (a measure representing a change in body composition)

    Time frame: 16 and 40 weeks

  8. Change in Blood lipids

    Time frame: 16 and 40 weeks

  9. Change in lean muscle mass (a measure representing change in body composition)

    Time frame: 16 and 40 weeks

  10. Change in Waist circumference (a measure representing change in body composition)

    Time frame: 16 and 40 weeks

  11. Change in Visceral Fat Rating (a measure representing change in body composition)

    Time frame: 16 and 40 weeks

Sponsors and collaborators

Lead sponsor

Medifast, Inc.

Industry

Registry information

Official study title

Efficacy of Medifast's 5 & 1 Program Compared to a Food-based Diet After a Period of Weight Loss and Weight Maintenance

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Nov 11, 2009
Registry last updated
Nov 11, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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