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Branched Chain Aminoacid Supplementation in Patients With Liver Cirrhosis

I

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Status and phase

Completed
Phase 4

Conditions

Liver Cirrhosis

Treatments

Other: High-fiber high protein diet
Dietary Supplement: Branched-chain aminoacids

Study type

Interventional

Funder types

Other

Identifiers

NCT02023229
Enterex01

Details and patient eligibility

About

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

Enrollment

68 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ambulatory patients Patients with confirmed diagnose of liver cirrhosis Patients classified as Child-Pugh A or Child Pugh B

Exclusion criteria

Acute or chronic renal failure Pregnancy Overt hepatic encephalopathy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

68 participants in 2 patient groups

Diet plus branched chain aminoacids
Experimental group
Description:
High-fiber high-protein diet Oral supplement : branched chain aminoacids
Treatment:
Other: High-fiber high protein diet
Dietary Supplement: Branched-chain aminoacids
Diet
Active Comparator group
Description:
High-fiber high-protein diet
Treatment:
Other: High-fiber high protein diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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