Skip to content
Clinical Trials – home

L-Alanine in Clinical Trials: Applications in Liver Disease and Cardiac Surgery

1 / 1
trials open to patients / all trials
1+
Countries

In short

L-Alanine is an amino acid being investigated in several clinical trials for its potential therapeutic benefits. Current research focuses on two main areas: as a standalone treatment for nonalcoholic steatohepatitis (a severe form of fatty liver disease) and as part of a dipeptide compound with glutamine for protecting the heart during cardiac surgery. These trials aim to assess L-alanine's safety, tolerability, and effectiveness in improving organ function and reducing damage during medical procedures. This article summarizes the current clinical research on L-alanine and its potential benefits for patients with liver disease and those undergoing cardiac procedures.

Key points

  • L-alanine is being investigated in clinical trials for its potential therapeutic benefits in two main areas. As a standalone treatment, it's being tested in patients with nonalcoholic steatohepatitis (NASH), a severe form of fatty liver disease, with dosages of 6-18g daily over a one-year period to assess improvements in liver function. Additionally, L-alanine is being studied as part of a dipeptide with glutamine (N(2)-L-Alanine L-Glutamine) in cardiac surgery patients to potentially protect the heart and other organs during procedures involving cardiopulmonary bypass. These cardiac trials measure markers of organ damage and function to determine if the compound can reduce injury and improve outcomes. Researchers are evaluating both safety and efficacy in these different applications, suggesting L-alanine may have diverse therapeutic uses.

What is L-Alanine?

L-Alanine is an amino acid, which is a building block for proteins in the human body. It's considered a non-essential amino acid because your body can produce it naturally, though it can also be obtained through diet or supplements. In medical settings, L-Alanine is being studied for its potential therapeutic benefits in various conditions.

L-Alanine is sometimes used in combination with other substances, particularly in the form of N(2)-L-Alanine L-Glutamine dipeptide (also known as Dipeptiven), which combines L-Alanine with glutamine to enhance stability and therapeutic effects.

Therapeutic Uses of L-Alanine

Research indicates that L-Alanine may have several therapeutic applications, particularly in liver disorders and cardiac conditions. Clinical trials have focused on investigating its effects in specific health conditions:

  • Liver disease - particularly nonalcoholic steatohepatitis (a type of liver inflammation caused by fat accumulation)
  • Cardiac protection - during heart surgeries involving cardiopulmonary bypass
  • Anti-oxidant effects - potentially reducing damage from harmful free radicals
  • Anti-inflammatory properties - possibly reducing inflammation in various tissues

L-Alanine for Nonalcoholic Steatohepatitis

One important application being studied is the use of L-Alanine in treating nonalcoholic steatohepatitis (NASH). This is a liver condition characterized by inflammation and fat accumulation in people who drink little to no alcohol. NASH can progress to more serious liver diseases, including cirrhosis and liver failure.

A clinical trial investigated the therapeutic effects of L-Alanine supplementation in patients with NASH. The study aimed to assess both the safety and effectiveness of long-term L-Alanine supplementation on liver function. The treatment protocol involved gradually increasing doses:

  1. 6g of L-Alanine powder once per day for the first month
  2. Twice per day (12g total) for the second month
  3. Three times per day (18g total) from the third month onward for 10 months

This study was designed to evaluate changes in liver biochemistry (blood tests that measure liver function) and histological findings (examination of tissue samples). Additionally, researchers aimed to understand L-Alanine's effects on gene expression, anti-oxidant response, and inflammatory processes in liver cells.

L-Alanine in Cardiovascular Applications

L-Alanine, particularly when combined with glutamine as N(2)-L-Alanine L-Glutamine dipeptide, is being studied for its potential protective effects during heart surgeries.

Two clinical trials have investigated the benefits of this combination in patients undergoing cardiac surgery:

1. For patients with coronary artery disease: This study examined whether glutamine (in the form of N(2)-L-Alanine L-Glutamine dipeptide) could protect the heart and intestines in patients with coronary atherosclerosis (narrowing of heart arteries) who underwent surgery with cardiopulmonary bypass. The treatment involved intravenous infusion during surgery and for 24 hours afterward.

2. For patients with aortic valve stenosis: Another study looked at whether glutamine administration could provide myocardial (heart muscle) protection in patients undergoing aortic valve replacement surgery. Aortic stenosis is a condition where the heart's aortic valve narrows, obstructing blood flow from the heart to the body. These patients are at high risk for ischemia-reperfusion injury (damage that occurs when blood supply returns to tissue after a period without oxygen).

In these cardiac applications, researchers measured various markers of heart damage (like Troponin T and CK-MB, which are proteins released when heart muscle is damaged) to assess whether L-Alanine/glutamine combination provided protective effects during and after surgery.

L-Alanine Formulations and Administration

In clinical studies, L-Alanine has been administered in different forms:

  • Oral powder form - for liver disease treatment, taken by mouth at doses ranging from 6-18g daily
  • Intravenous (IV) formulation - as part of N(2)-L-Alanine L-Glutamine dipeptide, administered directly into a vein during and after cardiac surgeries

The dosing schedules varied based on the condition being treated and the specific protocol of each clinical trial. For example, in cardiac surgery patients, the dipeptide was typically administered before, during, and shortly after surgery to provide protection during the critical period of potential heart damage.

Safety and Side Effects

One of the primary goals of the clinical trials was to assess the safety profile of L-Alanine, particularly with long-term use. The NASH study specifically aimed to evaluate "the safety and toxicity profile of long-term administration of L-alanine" over a one-year period.

The available information from these clinical trials does not specifically list common side effects. However, it's important to note that safety was a primary outcome measure in these studies, indicating that researchers were carefully monitoring for any adverse effects.

As with any medical treatment, patients should only use L-Alanine supplements under the guidance of a healthcare provider, who can monitor for potential side effects and adjust dosing as needed. This is particularly important since these applications of L-Alanine are still being researched and may not yet be approved as standard treatments for these conditions.

Questions people often ask

Conditions where L-ALANINE is being studied

Each condition opens its own overview and trial list

Trials with L-ALANINE

Recruiting trials first

See all 1 →
Quick filters
  • Participants:Adults · Healthy volunteers
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.