Nonalcoholic SteatohepatitisNCT00586885
Effects of Alanine in Patients With Nonalcoholic Steatohepatitis
A study testing L-alanine in people with Nonalcoholic Steatohepatitis, run by Keith D Lindor, M.D. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nonalcoholic Steatohepatitis
- What is being tested?
- L-alanine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2004to Jun 2006
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 34Show fewer
- 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
- Hemoglobin A1c >12%
- Renal or liver transplant patients
- Renal dysfunction in previous 3 months
- CCr <50ml/min
- Severe cardiovascular dysfunction in previous 6 months
- Congestive heart failure
- Uncontrolled hypertension
- Uncontrolled arrhythmia
- Patients with hyperlipidemia on a medical program for control of lipids which has had a change in drug treatment in the proceeding six months or with anticipated changes in the year of the study.
- Chronic pulmonary disease such as COPD requiring corticosteroid therapy in previous 3 months
- Active autoimmune or immunologically mediated diseases including systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel diseases in previous 12 months
- Previous (in three years) or present malignant disease except for non-melanoma skin cancer
- Untreated hyperthyroidism and hypothyroidism
- Substance abuse of oral, I.V., or inhaled drugs.
- If patients with history of substance abuse are considered as participants in this trial, patients must have abstained from using the abused substance for at least one year.
- Patients receiving methadone within the past 6 months are also excluded.
- Any other conditions that would make the patients unsuitable for enrollment in the opinion of the investigator in terms of interference in completing the trial and/or results of trial.
- Pregnant women
- Unwillingness of patients and /or partner to use contraceptive during treatment and for 3 months after discontinuation of treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study: Therapeutic Effect of L-Alanine in Patients With Nonalcoholic Steatohepatitis
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
- Being tested
- L-alanine
- Keywords
- Nonalcoholic Steatohepatitis, NASH, L-Alanine
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-alanineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Single arm, active treatment Receives: Drug: L-alanine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2008 (estimated)
- Study startFeb 2004
- Primary completionJun 2006
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nonalcoholic SteatohepatitisStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Keith D Lindor, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Responsible party
- Sponsor-investigator, Keith D Lindor, M.D., Mayo Clinic
- Investigators
- Keith D Lindor, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00586885
- Sponsor's protocol ID
- 1753-03
- Status last verified
- Oct 2012
- First submitted
- 21 Dec 2007
- Last updated
- 11 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study: Therapeutic Effect of L-Alanine in Patients With Nonalcoholic Steatohepatitis
- ClinicalTrials.gov ID
- NCT00586885
- Acronym / sponsor ID
- 1753-03
- Conditions
- Nonalcoholic Steatohepatitis
- Keywords
- Nonalcoholic Steatohepatitis, NASH, L-Alanine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Keith D Lindor, M.D.University, hospital or other
- Collaborators
- Ajinomoto USA, INC.
- Study start
- Feb 2004
- Primary completion
- Jun 2006 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 7 Jan 2008 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: L-alanineSingle arm, active treatment |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (34 listed)
- 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
- 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
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 |
|---|---|---|
| L-alanine6g 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. | Drug | 1 |
Primary outcome
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.
Time frame: 1 year
1 secondary outcome
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
Time frame: 1 year
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 11 Oct 2012.
- Results publicationSuzuki 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.
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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.
Keith D Lindor, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing L-alanine in people with Nonalcoholic Steatohepatitis, run by Keith D Lindor, M.D. 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 7 inclusion and 34 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 11 Oct 2012. 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?
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. (time frame: 1 year). 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 NCT00586885, which also lists 1 linked publication.
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 11 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.