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