Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138645
Status:
COMPLETED
Last Update Posted:
2016-02-08
First Post:
2005-08-29
Brief Title:
The Effects of Formula Diet on Body Weight Body Composition and Biomarkers for Disease Compared to a Standard Diet
Sponsor:
Pennington Biomedical Research Center
Organization:
Pennington Biomedical Research Center
Study Overview
Official Title:
The Effects of Formula Diet on Body Weight Body Composition and Biomarkers for Disease Compared to a Standard Diet
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FORMULA
Brief 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 eg 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None