Hypercaloric PEG Nutrition in ALS to Sustain Energy Homeostasis
This study is investigating if giving people with Amyotrophic Lateral Sclerosis (ALS) extra calories through a feeding tube (PEG) can slow down their disease progression. We know that losing weight can make ALS worse, and previous small studies have suggested that a higher-calorie diet might be helpful and safe. This trial aims to compare a diet with 120% of an individual's calorie needs to a standard diet with 100% of their needs. We will carefully measure each person's exact calorie requirements. The main goal is to see if the higher-calorie diet can lead to less disease progression over six months, as measured by a special blood test.
At a glance
What is this study about?
This study is looking into how nutrition might help people with Amyotrophic Lateral Sclerosis (ALS), sometimes called Motor Neurone Disease. We know that maintaining a healthy weight is really important for people with ALS, as losing too much weight can make the disease progress faster. In this study, we're focusing on people who are already using a feeding tube, known as a PEG, to get their nutrition.
Previous small studies have hinted that giving people with ALS extra calories through their PEG might be beneficial. These studies suggested that such a diet could be safe and might even help people live longer. However, these studies were quite small, so we need a larger trial to be more certain. The aim of this study is to compare two different approaches: one group will receive a standard amount of calories through their PEG (100% of their daily needs), while the other group will receive extra calories (120% of their daily needs).
To make sure we're giving the right amount of food to each person, we will precisely measure their individual calorie needs. This is done through a special breathing test and by tracking their activity. We believe that receiving more calories might help to slow down the progression of ALS. We'll be monitoring this by looking at changes in a specific marker in the blood over six months.
Key takeaways
- The study explores if extra calories through a PEG tube can help people with ALS.
- It compares 120% of daily calories to 100% daily calories via PEG.
- Individual calorie needs are precisely measured.
- The main goal is to see if extra calories slow disease progression.
- Participation lasts for six months.
Who may be eligible?
To be considered for this study, you must have a diagnosis of ALS that is either definite, probable, or possible. You must also be getting your nutrition through a PEG feeding tube.
You should be at least 18 years old. If you're taking Riluzole (a common ALS medication), you need to have been on a steady dose for at least four weeks, or not be taking it at all. It's also important that you can understand the study information and give your full permission to take part.
There are also some reasons why you might not be able to join. For example, if you've been in another similar study within the last four weeks, or if you are pregnant or breastfeeding. People with certain severe mental health conditions or dementia would also not be able to participate.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Do I have a diagnosis of ALS (definite, probable, or possible)?
- Am I currently receiving nutrition via a PEG feeding tube?
- Am I 18 years old or older?
- Am I able to understand study information and give my consent?
- Am I not pregnant or breastfeeding?
What does participation involve?
If you decide to join this study, your involvement would last for six months. At the beginning, you would have a visit where a doctor would check if you're suitable. Once enrolled, you would be randomly placed into one of two groups: either receiving 100% or 120% of your daily calorie needs through your PEG feeding tube. This amount would be carefully calculated for you individually using a special breathing test and an activity questionnaire.
You would continue your usual care and any medications, like Riluzole, as prescribed by your doctor. The study nutrition would be an addition to your standard care. Throughout the study, there will be regular check-ups to see how you're doing, and blood tests will be taken to measure the study's main outcome. The PEG nutrition used is a standard, widely available product, and if you experience any intolerance, it can be switched to another suitable product without changing the calorie amount.
Potential risks and benefits
Locations (1)
- Ulm Universita, Department of NeurologyVerified postcodeUlm, Germany· Recruiting
Common questions
What is a PEG feeding tube?
A PEG is a percutaneous endoscopic gastrostomy, which is a tube inserted directly into the stomach to provide nutrition when you can't eat enough by mouth.
What does 'hypercaloric' mean?
Hypercaloric simply means getting more calories than the standard amount needed for your body to function daily.
How will my calorie needs be measured?
Your calorie needs will be carefully measured using a special breathing test called indirect calorimetry and by asking questions about your daily physical activity.
What is the study looking for?
We are looking to see if more calories through the PEG can slow down the progression of ALS over six months, using a blood test marker.
How long will the study last?
If you participate, your involvement in the study will last for six months.
How to find out more
Christine Herrmann, Dr.
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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