BCAA Supplemental Study



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:18 - Any
Updated:3/2/2019
Start Date:October 2, 2017
End Date:December 1, 2019
Contact:Eric Kallwitz, MD
Email:ekallwitz@lumc.edu
Phone:855-483-7362

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BCAA Supplemental Study: Branched Chain Amino Acid and Physical Activity to Improve Muscle Mass in Patients With Cirrhosis

The central hypothesis of this study is that BCAA supplementation and BCAA supplementation
plus low-intensity activity will improve muscle mass and HRQOL in cirrhotic patients compared
to usual care

The purpose of this study is to look at the impact of including a physical activity program
and/or a nutritional supplement along with your regular care. The nutritional supplement used
in this study consists of branched-chain amino acids (BCAAs). BCAAs are found in certain
foods and are readily available as dietary supplements.

The investigators in this study will look at how the physical activity and nutritional
supplement program might affect patients' health outcomes, and if this program can maintain
or even increase muscle mass in patients with cirrhosis.

Participants will be randomized in three groups:

1. Standard Care: If the participant is randomized to this group, they will receive the
same medical care for their cirrhosis as they would if they were not participating in
the study. The doctor will provide them with some general information about healthy diet
and exercise. They will also be asked to keep an exercise log of the type of physical
activity they do on your own.

2. Nutritional Supplement: BCAAs: If the participant is randomized to this group, they will
be provided with BCAA powder to take during the 12 weeks of the study. They will be
asked to take 7 teaspoons per day. They will take 2-3 teaspoons after each meal. The
doctor will also provide them with some general information about healthy diet and
exercise, and they will also be asked to keep an exercise log of any physical activity
they do on your own.

3. Nutritional Supplement and Supervised Physical Activity: If the participant is
randomized to this group, they will be provided with BCAA powder and be asked to
participate in one hour per week of supervised fitness instruction at the Loyola Center
for Fitness. The fitness instruction will consist of low-impact aerobic exercise such as
walking or riding an exercise bicycle. They will also be given a list of exercises to
perform at home at least two times during the week and be asked to keep an exercise log
of their physical activity. The doctor will provide them with some general information
about healthy diet and exercise.

Inclusion Criteria:

1. Cirrhosis with ascites

2. MELD-Na score<25

Exclusion Criteria:

1. Pregnancy

2. Inability to engage in low-intensity physical activity due to any condition

3. Active acknowledged alcohol or substance abuse

4. Inability to complete protocol assessments.
We found this trial at
1
site
2160 South 1st Avenue
Maywood, Illinois 60153
(888) 584-7888
Phone: 855-483-7362
Loyola University Medical Center Loyola University Health System is committed to excellence in patient care...
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Maywood, IL
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