Obesity
Conditions
Keywords
Obesity, Weight loss, meal replacements, inflammation, oxidative stress, visceral fat
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.
Interventions
OTHERMedifast 5 & 1 Plan for weight loss and weight maintenance
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.
OTHERFood-based diet plan for weight loss and weight maintenance
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.
Sponsors
Medifast, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Weight change (in kilograms) from week 0 | 16 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Maintenance of weight lost during the 16 week weight loss phase expressed as weight regained from week 16 to week 40 (in kilograms) | 24 weeks |
| Satiety using a visual analog scale | 16 weeks |
| Change in Blood lipids | 16 and 40 weeks |
| Change in lean muscle mass (a measure representing change in body composition) | 16 and 40 weeks |
| Change in Waist circumference (a measure representing change in body composition) | 16 and 40 weeks |
| Change in Visceral Fat Rating (a measure representing change in body composition) | 16 and 40 weeks |
| Change in percent body fat (a measure representing a change in body composition) | 16 and 40 weeks |
Countries
United States
Outcome results
None listed