NCT03339232

BCAA Supplemental Study

Study Contact:

Study Phase:

Recruitment Status:

COMPLETED

NCT ID:

NCT03339232

Principal Investigator:

Study Type:

INTERVENTIONAL

Official Title:

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

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

Eligibility

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.

Disease(s) and\or Condition(s)

Cirrhosis

Primary Purpose

SUPPORTIVE_CARE

Intervention/Treatment

- Type: DIETARY_SUPPLEMENT
- Name: BCAA Supplement
- Description: 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.
- Arm Group Labels: BCAA Supplement, BCAA supplement plus supervised physical activity
- Type: OTHER
- Name: Physical Activity
- Description: Supervised low impact aerobic physical activity for one hour each week.
- Arm Group Labels: BCAA supplement plus supervised physical activity

Sponsor

Loyola University