DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Nutritional Effect of an Amino Acid Mixture on Lean Body Mass (LBM) in Post-bariatric Surgery Patients

Information source: University of Alabama at Birmingham
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Obesity; Post-gastric Bypass

Intervention: receive amino acid supplement (Dietary Supplement)

Phase: N/A

Status: Completed

Sponsored by: University of Alabama at Birmingham

Official(s) and/or principal investigator(s):
Ronald H Clements, MD, Principal Investigator, Affiliation: University of Alabama at Birmingham


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.

Clinical Details

Official title: Nutritional Effect of an Amino Acid Mixture on Lean Body Mass (LBM) in Post-bariatric Surgery Patients

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Change in LBM

Secondary outcome: Change in fasting serum IGF-1, Leptin, Ghrelin, Gastric Inhibitory Polypeptide (GIP), Glucagon-Like Peptide-1 (GLP-1), Insulin, C Reactive Protein, IL-6, albumen, pre-albumin and glucose, and RMR

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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria:

- Each person who has been judged to be an acceptable candidate for laparoscopic

gastric bypass (LGB) will be asked to participate in this protocol when they are scheduled for the operation. Exclusion Criteria:

- Age less than 18

- Pregnant females

- Weight greater than the limit of the DEXA table (Patients over 300 pounds)

- Known allergy to any component fo the amino acid supplement

Locations and Contacts

UAB Kirklin Clinic, Birmingham, Alabama 35294, United States
Additional Information

Starting date: June 2007
Last updated: November 17, 2013

Page last updated: August 23, 2015

-- advertisement -- The American Red Cross
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017