The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet (FORMULA)
|ClinicalTrials.gov Identifier: NCT00138645|
Recruitment Status : Completed
First Posted : August 30, 2005
Results First Posted : June 10, 2009
Last Update Posted : February 8, 2016
|Condition or disease||Intervention/treatment||Phase|
|Body Weight Changes||Behavioral: MicroDiet Behavioral: Healthy Diet||Phase 4|
In recent decades, the prevalence of overweight and obesity has increased dramatically in developed countries. Obesity is associated with diseases such as diabetes, cardiovascular disease, hypertension, and certain cancers. Modest amounts of weight loss (e.g., 5% to 10% of initial body weight) significantly improve health and improve disease status. Recent evidence suggests that the use of supplements or meal replacements promotes greater weight loss than isocaloric food-based diets. In addition, diets that are high in protein are associated with greater ratings of satiety and reduced food intake, as well as greater weight loss, compared to lower protein diets.
The purpose of the proposed study is to test the effect of a partial supplement diet on body weight, body composition, and biomarkers for disease compared to an isocaloric diet that consists of a traditional food-based meal plan. Overweight and obese (BMI 25 to 35) participants will participate in this six-month study. The primary outcome variable is body weight loss and the secondary outcome variables include body composition, blood pressure, lipids, and subjective ratings of satiety.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||May 2006|
|Actual Study Completion Date :||May 2006|
Participants randomized to the MicroDiet group (1200 kcal/day) will be instructed by a Registered Dietitian to consume (one shake and 3 cookies; 240 kcal) for two meals each day for Months 1 through 3. They will be provided with meal plans for the meal that they do not replace with MicroDiet. During Months 4 through 6, participants in the MicroDiet group will be instructed to replace one meal per day with MD (the energy content of the meal plan will still be 1200 kcal/day). Participants will also be encouraged to eat or drink MD for snacks. The rest of the diet will consist of healthy foods, as outlined above. To help participants adhere to the MicroDiet regimen, they will meet with a registered dietitian for one hour at Week 0 and 30 minutes at Weeks 2 and 4, and every month thereafter.
Active Comparator: Healthy Diet
Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet. The Healthy Diet will consist of the same foods that are used in the meal plans for the MicroDiet group. The Healthy Diet group will be instructed not to use meal replacements such as shakes (e.g., Slim Fast®), nutrition bars (e.g., Balance Bar®), or portion-controlled meals (e.g., Healthy Choice entrees).
Behavioral: Healthy Diet
Participants randomized to the Healthy Diet group will be prescribed a traditional food-based diet that contains the same number of kilocalories (1200/day) as the MicroDiet but will be instructed not to use meal replacements
- Body Weight Loss (kg and Percent) at Months 3 and 6 [ Time Frame: April 2005 to May 2006 ]
- Percent Change in Body Weight (Completers). [ Time Frame: 24 weeks ]Percent change in body weight from baseline to week 24(completers).
- Change in Body Composition at Months 3 and 6 [ Time Frame: April 2005 to May 2006 ]
- Disease Biomarkers (Cholesterol, Triglycerides, Etc.) at Months 3 and 6 [ Time Frame: April 2005 to May 2006 ]
- Subjective Ratings of Appetite at Week 2 and Months 1, 2, 3, 4, 5, and 6 [ Time Frame: April 2005 to May 2006 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138645
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|
|Principal Investigator:||Corby K. Martin, Ph.D.||Pennington Biomedical Research Center|