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BCAA Supplemental Study

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ClinicalTrials.gov Identifier: NCT03339232
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : February 28, 2019
Sponsor:
Information provided by (Responsible Party):
Eric Kallwitz, 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

Condition or disease Intervention/treatment Phase
Cirrhosis Dietary Supplement: BCAA Supplement Other: Physical Activity Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are randomized into one of three arms
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: BCAA Supplemental Study: Branched Chain Amino Acid and Physical Activity to Improve Muscle Mass in Patients With Cirrhosis
Actual Study Start Date : October 2, 2017
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Usual Care
Participants will receive standardized information about a healthy diet, including the potential benefit of small, frequent meals and nighttime snacking . In addition, the treating hepatologist will counsel participants on the benefits of increased physical activity. These recommendations will be provided at the beginning of the study. The usual care arm reflects current clinical practice. Participants will be asked to keep an exercise log detailing type and duration of at home physical activity.
BCAA Supplement
BCAA powder (Bulk Supplements®) will be provided as the powder was found to be easier to swallow. Each teaspoon contains 1788 mg of BCAA and participants will take 7 teaspoons (12.5 grams of BCAA) per day divided into three separate servings. Each teaspoon contains L-leucine, isoleucine and valine in a 2:1:1 ratio. BCAA will be provided by the study investigators and half will be provided at baseline study visit and the second half at the week 6 visit. In addition, the treating hepatologist will provide standardized information about the potential benefits of small, frequent meals, nighttime snacking and increased physical activity at the beginning of the study. Participants will be asked to keep an exercise log detailing type and duration of at home physical activity.
Dietary Supplement: BCAA Supplement
Each teaspoon contains 1788 mg of BCAA and participants will take 7 teaspoons (12.5 grams of BCAA) per day divided into three separate servings. Each teaspoon contains L-leucine, isoleucine and valine in a 2:1:1 ratio.

BCAA supplement plus supervised physical activity
BCAA supplement will be as described for group 2, above. Study coordinators will supervise the physical activity program for study participants at the Loyola Fitness Center. Participants will attend the fitness center one hour each week; the fitness session will consist of low-impact aerobic physical activity, beginning with walking on the indoor track and possibly building to a recumbent exercise bicycle and light resistance training. Participants will be given a list of exercises to perform at home at least two times during the week with a goal of >90 minutes of physical activity per week. Participants will be asked to keep an exercise log detailing type and duration of at home physical activity which they will return during the weekly fitness center sessions. In addition, the treating hepatologist will provide standardized information about the potential benefits of small, frequent meals, nighttime snacking and increased physical activity at the beginning of the study.
Dietary Supplement: BCAA Supplement
Each teaspoon contains 1788 mg of BCAA and participants will take 7 teaspoons (12.5 grams of BCAA) per day divided into three separate servings. Each teaspoon contains L-leucine, isoleucine and valine in a 2:1:1 ratio.

Other: Physical Activity
Supervised low impact aerobic physical activity for one hour each week.




Primary Outcome Measures :
  1. Muscle Mass [ Time Frame: 12 weeks ]
    Appendicular lean muscle mass will be measured by whole body DXA using a standard protocol.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339232


Contacts
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Contact: Eric Kallwitz, MD 855-483-7362 ekallwitz@lumc.edu
Contact: Amy Luke, PHD 708-327-9011 aluke@lumc.edu

Locations
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United States, Illinois
Loyola University Medical Center Recruiting
Maywood, Illinois, United States, 60153
Contact: Eric Kallwitz, MD    855-483-7362    ekallwitz@lumc.edu   
Contact: Amy Luke, PHD    708-327-9011    aluke@lumc.edu   
Sponsors and Collaborators
Loyola University

Publications:

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Responsible Party: Eric Kallwitz, Assistant Professor, Loyola University
ClinicalTrials.gov Identifier: NCT03339232     History of Changes
Other Study ID Numbers: 210050
First Posted: November 13, 2017    Key Record Dates
Last Update Posted: February 28, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Fibrosis
Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases