NCT00138645

The Effects of Formula Diet on Body Weight, Body Composition, and Biomarkers for Disease Compared to a Standard Diet

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

It is hypothesized that the use of a partial supplement diet, which includes the use of meal replacements, will result in significantly greater weight loss after three and six months compared to an isocaloric diet that does not include supplements. It is also hypothesized that the partial supplement diet will result in larger improvements in body composition, disease biomarkers, and health parameters (blood pressure, lipids) compared to the non-supplement diet. Finally, it is hypothesized that subjective ratings of satiety will be significantly higher, and ratings of hunger lower, in the group consuming a partial supplement diet.

Detailed description

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.

Conditions

• Body Weight Changes

Interventions

Type	Name	Description
BEHAVIORAL	MicroDiet	MicroDiet
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

Timeline

• Start date: 2005-04-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2005-08-30
• Last updated: 2016-02-08
• Results posted: 2009-06-10

Locations

1 site across 1 country: United States