CirrhosisNCT03339232

BCAA Supplemental Study

A study testing BCAA Supplement and Physical Activity in people with Cirrhosis, run by Loyola University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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 Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cirrhosis
What is being tested?: BCAA Supplement and Physical Activity
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited States
Study dates: 2 Oct 2017to 17 Jun 2019
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Cirrhosis with ascites
MELD-Na score<25

Who cannot join

Pregnancy
Inability to engage in low-intensity physical activity due to any condition
Active acknowledged alcohol or substance abuse
Inability to complete protocol assessments.

Trial locations and contacts

1 site in 1 country.

United States1 site

Loyola University Medical Center
Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: 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

Read the 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:

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.
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.
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.

Conditions: Cirrhosis
Being tested: BCAA Supplement, Physical Activity
Medical subject headings: Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BCAA SupplementDietary 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.
Physical ActivityOther
Supervised low impact aerobic physical activity for one hour each week.

Study groups in NCT03339232
Study group	Role	What they receive
Usual Care	No intervention	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	Other	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. Receives: Dietary Supplement: BCAA Supplement
BCAA supplement plus supervised physical activity	Other	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. Receives: Dietary Supplement: BCAA Supplement; Other: Physical Activity

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Oct 201717 Jun 2019

First posted13 Nov 2017
Study start2 Oct 2017
Primary completion17 Jun 2019
Study completion17 Jun 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for CirrhosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Model description: Participants are randomized into one of three arms
Masking: None (open label)
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03339232
Sponsor's protocol ID: 210050
Status last verified: Jun 2020
First submitted: 8 Nov 2017
Last updated: 24 Jun 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Scaglione S, Kliethermes S, Cao G, Shoham D, Durazo R, Luke A, Volk ML. The Epidemiology of Cirrhosis in the United States: A Population-based Study. J Clin Gastroenterol. 2015 Sep;49(8):690-6. doi: 10.1097/MCG.0000000000000208.
PubMed 25291348
Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.
PubMed 10451460
Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.
PubMed 15565570
Kallwitz ER, Guzman G, TenCate V, Vitello J, Layden-Almer J, Berkes J, Patel R, Layden TJ, Cotler SJ. The histologic spectrum of liver disease in African-American, non-Hispanic white, and Hispanic obesity surgery patients. Am J Gastroenterol. 2009 Jan;104(1):64-9. doi: 10.1038/ajg.2008.12.
PubMed 19098851
Darmon N, Drewnowski A. Does social class predict diet quality? Am J Clin Nutr. 2008 May;87(5):1107-17. doi: 10.1093/ajcn/87.5.1107.
PubMed 18469226
Gordon-Larsen P, Nelson MC, Page P, Popkin BM. Inequality in the built environment underlies key health disparities in physical activity and obesity. Pediatrics. 2006 Feb;117(2):417-24. doi: 10.1542/peds.2005-0058.
PubMed 16452361
Merli M, Giusto M, Gentili F, Novelli G, Ferretti G, Riggio O, Corradini SG, Siciliano M, Farcomeni A, Attili AF, Berloco P, Rossi M. Nutritional status: its influence on the outcome of patients undergoing liver transplantation. Liver Int. 2010 Feb;30(2):208-14. doi: 10.1111/j.1478-3231.2009.02135.x. Epub 2009 Oct 14.
PubMed 19840246
Hong HC, Hwang SY, Choi HY, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Relationship between sarcopenia and nonalcoholic fatty liver disease: the Korean Sarcopenic Obesity Study. Hepatology. 2014 May;59(5):1772-8. doi: 10.1002/hep.26716. Epub 2014 Mar 24.
PubMed 23996808
Issa D, Alkhouri N, Tsien C, Shah S, Lopez R, McCullough A, Dasarathy S. Presence of sarcopenia (muscle wasting) in patients with nonalcoholic steatohepatitis. Hepatology. 2014 Jul;60(1):428-9. doi: 10.1002/hep.26908. Epub 2014 May 27. No abstract available.
PubMed 24990106
Hayashi F, Matsumoto Y, Momoki C, Yuikawa M, Okada G, Hamakawa E, Kawamura E, Hagihara A, Toyama M, Fujii H, Kobayashi S, Iwai S, Morikawa H, Enomoto M, Tamori A, Kawada N, Habu D. Physical inactivity and insufficient dietary intake are associated with the frequency of sarcopenia in patients with compensated viral liver cirrhosis. Hepatol Res. 2013 Dec;43(12):1264-75. doi: 10.1111/hepr.12085. Epub 2013 Mar 12.
PubMed 23489325

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis

All Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BCAA Supplemental Study: Branched Chain Amino Acid and Physical Activity to Improve Muscle Mass in Patients With Cirrhosis
ClinicalTrials.gov ID: NCT03339232
Acronym / sponsor ID: 210050
Conditions: Cirrhosis
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: Loyola UniversityUniversity, hospital or other
Study start: 2 Oct 2017 (actual)
Primary completion: 17 Jun 2019 (actual)
Study completion: 17 Jun 2019 (actual)
First posted: 13 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Participants will be randomized in three groups:

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.
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.
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 design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3
Model description: Participants are randomized into one of three arms

Arm	Type	Receives
Usual Care	No intervention	–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	Other	Dietary Supplement: BCAA SupplementBCAA 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.
BCAA supplement plus supervised physical activity	Other	Dietary Supplement: BCAA Supplement, Other: Physical ActivityBCAA 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

Cirrhosis with ascites
MELD-Na score<25

Key exclusion criteria (4 listed)

Pregnancy
Inability to engage in low-intensity physical activity due to any condition
Active acknowledged alcohol or substance abuse
Inability to complete protocol assessments.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BCAA SupplementEach 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.	Dietary supplement	BCAA Supplement, BCAA supplement plus supervised physical activity
Physical ActivitySupervised low impact aerobic physical activity for one hour each week.	Other	BCAA supplement plus supervised physical activity

Primary outcome

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2020.
Background: PubMed 25291348Scaglione S, Kliethermes S, Cao G, Shoham D, Durazo R, Luke A, Volk ML. The Epidemiology of Cirrhosis in the United States: A Population-based Study. J Clin Gastroenterol. 2015 Sep;49(8):690-6. doi: 10.1097/MCG.0000000000000208.
Background: PubMed 10451460Alter MJ, Kruszon-Moran D, Nainan OV, McQuillan GM, Gao F, Moyer LA, Kaslow RA, Margolis HS. The prevalence of hepatitis C virus infection in the United States, 1988 through 1994. N Engl J Med. 1999 Aug 19;341(8):556-62. doi: 10.1056/NEJM199908193410802.
Background: PubMed 15565570Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.
Background: PubMed 19098851Kallwitz ER, Guzman G, TenCate V, Vitello J, Layden-Almer J, Berkes J, Patel R, Layden TJ, Cotler SJ. The histologic spectrum of liver disease in African-American, non-Hispanic white, and Hispanic obesity surgery patients. Am J Gastroenterol. 2009 Jan;104(1):64-9. doi: 10.1038/ajg.2008.12.
Background: PubMed 18469226Darmon N, Drewnowski A. Does social class predict diet quality? Am J Clin Nutr. 2008 May;87(5):1107-17. doi: 10.1093/ajcn/87.5.1107.
Background: PubMed 16452361Gordon-Larsen P, Nelson MC, Page P, Popkin BM. Inequality in the built environment underlies key health disparities in physical activity and obesity. Pediatrics. 2006 Feb;117(2):417-24. doi: 10.1542/peds.2005-0058.
Background: PubMed 19840246Merli M, Giusto M, Gentili F, Novelli G, Ferretti G, Riggio O, Corradini SG, Siciliano M, Farcomeni A, Attili AF, Berloco P, Rossi M. Nutritional status: its influence on the outcome of patients undergoing liver transplantation. Liver Int. 2010 Feb;30(2):208-14. doi: 10.1111/j.1478-3231.2009.02135.x. Epub 2009 Oct 14.
Background: PubMed 23996808Hong HC, Hwang SY, Choi HY, Yoo HJ, Seo JA, Kim SG, Kim NH, Baik SH, Choi DS, Choi KM. Relationship between sarcopenia and nonalcoholic fatty liver disease: the Korean Sarcopenic Obesity Study. Hepatology. 2014 May;59(5):1772-8. doi: 10.1002/hep.26716. Epub 2014 Mar 24.
Background: PubMed 24990106Issa D, Alkhouri N, Tsien C, Shah S, Lopez R, McCullough A, Dasarathy S. Presence of sarcopenia (muscle wasting) in patients with nonalcoholic steatohepatitis. Hepatology. 2014 Jul;60(1):428-9. doi: 10.1002/hep.26908. Epub 2014 May 27. No abstract available.
Background: PubMed 23489325Hayashi F, Matsumoto Y, Momoki C, Yuikawa M, Okada G, Hamakawa E, Kawamura E, Hagihara A, Toyama M, Fujii H, Kobayashi S, Iwai S, Morikawa H, Enomoto M, Tamori A, Kawada N, Habu D. Physical inactivity and insufficient dietary intake are associated with the frequency of sarcopenia in patients with compensated viral liver cirrhosis. Hepatol Res. 2013 Dec;43(12):1264-75. doi: 10.1111/hepr.12085. Epub 2013 Mar 12.
Individual participant dataSharing planned: No

Related trials for Cirrhosis

RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Not yet recruitingObservational study
Development and Validation of a TIPS Prognostic Model
Portal Hypertension Related to Cirrhosis, Ascites
RecruitingPhase 3
FIREFLY Trial: Fenofibrate Intervention---Randomized Evaluation in First-Line PBC Therapy
Primary Biliary Cholangitis (PBC)
RecruitingPhase 3
Seladelpar in Subjects With Primary Biliary Cholangitis (PBC) and Compensated Cirrhosis
Primary Biliary Cholangitis
RecruitingPhase 1/2
N-Acetylcysteine in the Management of Spontaneous Bacterial Peritonitis
SBP - Spontaneous Bacterial Peritonitis

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing BCAA Supplement and Physical Activity in people with Cirrhosis, run by Loyola University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Muscle Mass (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03339232, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2020.