MedDataX Logo

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

NCT ID: NCT00473356

Last Updated: 2013-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2010-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obesity Post-gastric Bypass

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Morbid obesity Lean body mass amino acid supplement laparoscopic gastric bypass

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

to receive amino acid supplement

Group Type ACTIVE_COMPARATOR

receive amino acid supplement

Intervention Type DIETARY_SUPPLEMENT

Receive amino acid supplement

2

no amino acid supplement

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

receive amino acid supplement

Receive amino acid supplement

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Abbott Nutrition

INDUSTRY

Sponsor Role collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ronald H Clements, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UAB Kirklin Clinic

Birmingham, Alabama, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BJ94

Identifier Type: -

Identifier Source: secondary_id

F061211001

Identifier Type: -

Identifier Source: org_study_id