Effects of Alanine in Patients With Nonalcoholic Steatohepatitis

NCT00586885 | Completed

• 1 other identifier: 1753-03
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief Summary

Purpose of this study is to assess the therapeutic efficacy of L-alanine in improving biological and histological findings by administrating 6-18g/day L-alanine for one year. We will also assess the safety and toxicity profile of long-term administration of L-alanine.

Conditions

Nonalcoholic Steatohepatitis

Keywords

Nonalcoholic Steatohepatitis; NASH; L-Alanine

Outcome Measures

Primary Outcomes (1)

• To assess the safety and tolerability of long-term L-alanine supplementation and the therapeutic efficacy of long-term L-alanine supplementation by evaluating liver biochemistry and histological findings.

  1 year

Secondary Outcomes (1)

• Determine the effect of L-alanine on gene profiles, anti-oxidant response and inflammatory response in hepatocytes. Evaluate possible correlation between therapeutic efficacy and gene profiles altered by L-alanine supplementation

  1 year

Study Arms (1)

1

EXPERIMENTAL

Single arm, active treatment

Drug: L-alanine

Interventions

L-alanine DRUG

6g of L-alanine (powder)once per day for the first month, twice per day for the second month, then three times per day from the third month for 10 months.

1

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females, age between 18 and 75
• Histological diagnosis of steatohepatitis with or without fibrosis made within one year of entry
• Transaminase levels (ALT or AST) more than 1.5 times the upper normal limit on at least two occasions with one assessment in three months or more prior to treatment of this study
• Previous and current alcohol consumption less than 20g per day by patient-provided information.
• Written informed consent specific for this protocol available prior to entry.
• Patients with diabetes and on stable medical management for six months prior to entry and an anticipated stable program throughout the study will be eligible. Medications that may be used include insulin, biguanides and sulfonylureas.
• Patients with congestive heart failure, hypertension and arrhythmia controlled by medications and without cardiac episodes during the past 6 months will be eligible.

You may not qualify if:

• Any causes for liver disease other than nonalcoholic steatohepatitis that are confirmed by patient history, laboratory data, or histological data
• Decompensated liver disease based on laboratory data, or clinical manifestations
• Hemoglobin \<11.0g/dl for male, \<10.0 g/dl for female
• White blood cells \<2000 /mm3
• Platelet count \<50,000/mm3
• Prothrombin time \>INR 1.5
• Total Bilirubin \>2.0 g/dl
• Albumin \<3.0/dl
• The presence of ascites
• The presence of bleeding varices
• The presence of spontaneous encephalopathy
• Any previous experimental treatment of NASH within the past 3 months such as betaine, thiazolidinediones, α-tocopherol, or UDCA
• Pre-existing diseases/situations that could interfere with the results or the completion of this trial.
• Uncontrolled diabetes mellitus meeting following criteria in previous 3 months
• Fasting blood sugar \>200 mg/dl

Sponsors & Collaborators

• Keith D Lindor, M.D.: lead
• Ajinomoto USA, INC.: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• Suzuki A, Charlton MR, Lymp JF, et al. A pilot study: No therapeutic effect of L-alanine in patients with nonalcoholic steatohepatitis. Food and Nutrition Sciences 2: 67-73, 2010.

  RESULT

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Interventions

Alanine

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Keith D Lindor, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: January 7, 2008
• Study Start: February 1, 2004
• Primary Completion: June 1, 2006
• Study Completion: June 1, 2006
• Last Updated: October 11, 2012

Record last verified: 2012-10

Locations

US (1)