Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00299273
Status:
TERMINATED
Last Update Posted:
2015-06-08
First Post:
2006-03-02
Brief Title:
High Fat - High Protein Diet in the Treatment of Obesity
Sponsor:
Rockefeller University
Organization:
Rockefeller University
Study Overview
Official Title:
Exploratory Feasibility Study High FatProtein Diet in the Treatment of Obesity
Status:
TERMINATED
Status Verified Date:
2015-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
PI left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the effects of a low calorie high fatprotein diet on body fat and body composition in overweight and obese subjects The investigators will also test the effects of this diet on secondary outcomes such as fluid and electrolyte balance cholesterol inflammation sugar and insulin metabolism fat hormones blood pressure and feelings of fullness
Detailed Description:
Participation in this study requires 2 screening visits to the outpatient clinic and if participants qualify 10 inpatient study weeks
Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study The first 2 weeks consist of a weight stabilization period during which subjects will be required to eat an average American diet This is followed by the 6 week weight loss period where subjects will be put on a low calorie high fatprotein diet During the weight loss period calories will be cut by 50 compared to the weight stabilization period This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight Appropriate adjustments will be made to keep the subjects weight stable
During the entire inpatient study subjects will consume one multivitamin per day Centrum always complete from A to Zinc and one iron supplement per day In addition unlimited access to zero calorie liquids waterdiet soda will be available and subjects will be encouraged to maintain their usual activity level
Females of reproductive age need to make sure that they do not become pregnant during the inpatient study Urine will be tested for pregnancy once during each phase of the study
Subjects will be admitted to the Rockefeller University Hospital for the 10 week in-patient phase of the study The first 2 weeks consist of a weight stabilization period during which subjects will be required to eat an average American diet This is followed by the 6 week weight loss period where subjects will be put on a low calorie high fatprotein diet During the weight loss period calories will be cut by 50 compared to the weight stabilization period This will be followed by a 2 week weight maintenance period during which calories will be added to the diet to maintain the new weight Appropriate adjustments will be made to keep the subjects weight stable
During the entire inpatient study subjects will consume one multivitamin per day Centrum always complete from A to Zinc and one iron supplement per day In addition unlimited access to zero calorie liquids waterdiet soda will be available and subjects will be encouraged to maintain their usual activity level
Females of reproductive age need to make sure that they do not become pregnant during the inpatient study Urine will be tested for pregnancy once during each phase of the study
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