Liver CirrhosisPhase 4NCT02023229
Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis
A Phase 4 study testing Branched-chain aminoacids and High-fiber high protein diet in people with Liver Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
Trial summary
Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines. We hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Branched-chain aminoacids and High-fiber high protein diet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMexico
- Study dates
- Jan 2011to May 2013
- Phase
- Phase 4
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B
Who cannot join
- Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Instituto Nacional de Ciencias Médicas y Nutrición "Salvador Zubirán"
Mexico City, 14000
About this study
Official title: High-fiber High-fiber Diet and Branched Chain Aminoacids. Impact on Nutritional Status and Complications in Patients With Liver Cirrhosis
Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines.
We hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy
- Conditions
- Liver Cirrhosis
- Being tested
- Branched-chain aminoacids, High-fiber high protein diet
- Keywords
- Branched chain aminoacids, Nutritional status, Hepatic encephalopathy
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Branched-chain aminoacidsDietary supplement
High-fiber high protein dietOther
| Study group | Role | What they receive |
|---|---|---|
| Diet plus branched chain aminoacids | Experimental | High-fiber high-protein diet Oral supplement : branched chain aminoacids Receives: Dietary Supplement: Branched-chain aminoacids; Other: High-fiber high protein diet |
| Diet | Active comparator | High-fiber high-protein diet Receives: Other: High-fiber high protein diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nutritional status
Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference
Measured: At time of recruitment
Secondary outcomes (1)
Hepatic Encephalopathy
Measured: At time of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startJan 2011
- Primary completionJan 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ALDO TORRE DELGADILLO, Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023229
- Sponsor's protocol ID
- Enterex01
- Status last verified
- Dec 2013
- First submitted
- 23 Dec 2013
- Last updated
- 30 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- High-fiber High-fiber Diet and Branched Chain Aminoacids. Impact on Nutritional Status and Complications in Patients With Liver Cirrhosis
- ClinicalTrials.gov ID
- NCT02023229
- Acronym / sponsor ID
- Enterex01
- Conditions
- Liver Cirrhosis
- Keywords
- Branched chain aminoacids, Nutritional status, Hepatic encephalopathy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Instituto Nacional de Ciencias Medicas y Nutricion Salvador ZubiranUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 30 Dec 2013 (estimated)
- 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.
Malnutrition is a frequent complication in patients with liver cirrhosis. Most patients have decreased dietary intake due to ascites, hepatic encephalopathy and pro-inflammatory cytokines.
We hypothesized that branched chain aminoacids can improve nutritional status and delay episodes of hepatic encephalopathy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diet plus branched chain aminoacids | Experimental | Dietary Supplement: Branched-chain aminoacids, Other: High-fiber high protein dietHigh-fiber high-protein diet Oral supplement : branched chain aminoacids |
| Diet | Active comparator | Other: High-fiber high protein dietHigh-fiber high-protein diet |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B
Key exclusion criteria (1 listed)
- Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy
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 |
|---|---|---|
| Branched-chain aminoacids | Dietary supplement | Diet plus branched chain aminoacids |
| High-fiber high protein diet | Other | Diet, Diet plus branched chain aminoacids |
Primary outcome
Nutritional status
Time frame: At time of recruitment
Assessed by bioelectrical impedance vector analysis and mid-arm muscle circumference
1 secondary outcome
Hepatic Encephalopathy
Time frame: At time of recruitment
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 30 Dec 2013.
Related trials for Liver Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
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 Phase 4 study testing Branched-chain aminoacids and High-fiber high protein diet in people with Liver Cirrhosis, run by Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran at 1 site in Mexico.
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 1 inclusion and 1 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 30 Dec 2013. 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 Mexico. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Nutritional status (time frame: At time of recruitment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Dec 2013.