BCAA Supplemental Study

Not Applicable

Completed

• Conditions: Cirrhosis

• Registration Number: NCT03339232
• Lead Sponsor: Loyola University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2017-10-02
• Study First Submitted: 2017-11-08
• Study First Submitted QC: 2017-11-08
• Study First Posted: 2017-11-13
• Primary Completion: 2019-06-17
• Study Completion: 2019-06-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-22
• Last Update Posted: 2020-06-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Muscle Mass	12 weeks	Appendicular lean muscle mass will be measured by whole body DXA using a standard protocol.

Trial Locations

Locations (1)

Loyola University Medical Center; 🇺🇸 Maywood, Illinois, United States