Ignite Creation Date:
2024-05-05 @ 5:31 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00473356
Status:
COMPLETED
Last Update Posted:
2013-11-19
First Post:
2007-05-10
Brief Title:
Nutritional Effect of an Amino Acid Mixture on Lean Body Mass LBM in Post-bariatric Surgery Patients
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Nutritional Effect of an Amino Acid Mixture on Lean Body Mass LBM in Post-bariatric Surgery Patients
Status:
COMPLETED
Status Verified Date:
2013-11
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:
None
Brief Summary:
The Focus of this study is to look at the role of nutrition in maintaining lean body mass post-gastric bypass surgery The purpose of this study is to test whether LBM is increased in those patients receiving a nutritional supplement of amino acids is enhanced when compared to control patients not receiving the supplement
Detailed Description:
You are being asked to participate in a pilot initial research study designed to test how effectively a nutritional supplement Juven helps people keep lean muscle mass the amount of muscle tissue in your body and sustain weight loss after gastric bypass surgery Abbott laboratories the manufacturer of Juven sponsors this research study Juven is commercially available without prescription in the United States
If you decide to participate you will have a DEXA scan to check your lean body mass an indirect calorimetry your breath is collected for a period of time and is analyzed test to check your basal metabolic rate how much energy your body uses at rest and a blood test to check your certain hormone made by your intestines bowel or guts Each of these tests will be run on you three times Once before your gastric bypass surgery once 2 weeks after your surgery and once two months after your surgery
If you qualify for the study you will be randomly like the flip of a coin assigned by a computer to receive either Juven twice a day by mouth or to continue with standard care
As part of your normal post-operative instructions you should avoid becoming pregnant for two years after your surgery Acceptable forms of birth control after gastric bypass include barrier methods condoms diaphragm etc Depo-Provera the shot and Nuva-Ring Vaginal ring The birth control pill is not as reliable after gastric bypass because its absorption is unpredictable The effects of Juven in pregnant women have not been tested If you should become pregnant you should stop taking Juven and notify Dr Clements or his staff
If you decide to participate you will have a DEXA scan to check your lean body mass an indirect calorimetry your breath is collected for a period of time and is analyzed test to check your basal metabolic rate how much energy your body uses at rest and a blood test to check your certain hormone made by your intestines bowel or guts Each of these tests will be run on you three times Once before your gastric bypass surgery once 2 weeks after your surgery and once two months after your surgery
If you qualify for the study you will be randomly like the flip of a coin assigned by a computer to receive either Juven twice a day by mouth or to continue with standard care
As part of your normal post-operative instructions you should avoid becoming pregnant for two years after your surgery Acceptable forms of birth control after gastric bypass include barrier methods condoms diaphragm etc Depo-Provera the shot and Nuva-Ring Vaginal ring The birth control pill is not as reliable after gastric bypass because its absorption is unpredictable The effects of Juven in pregnant women have not been tested If you should become pregnant you should stop taking Juven and notify Dr Clements or his staff
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BJ94 | None | None | None |