Active not recruitingNAINTERVENTIONAL

Formula Diet Treatment for NASH Patients.

This study is exploring a new way to help people with a liver condition called NASH, also known as fatty liver. NASH is a serious issue because it causes fat build-up and inflammation in the liver, which can lead to scarring, shrinking of the liver, and other severe problems. Currently, there isn't a widely approved treatment. However, there's a belief that making big lifestyle changes, like eating fewer carbohydrates, exercising more, and losing a significant amount of weight, could make a difference. This particular study will give participants a special formula diet for 12 weeks to see if it helps improve their liver health.

At a glance

Status

Active not recruiting

Phase

Sponsor

West German Center of Diabetes and Health

Enrolment target

Start

18 Jan 2021

Estimated completion

31 Dec 2027

Steatohepatitis, Nonalcoholic

What is this study about?

This study is about a liver condition called non-alcoholic steatohepatitis, or NASH for short. You might also hear it called fatty liver. It's a serious health concern because it causes fat to build up in the liver, leading to inflammation and stiffness. Over time, this can cause damage like scarring (liver fibrosis), shrinking of the liver (cirrhosis), and can even increase the risk of liver cancer or other severe health issues.

At the moment, there isn't one specific treatment that doctors routinely use for NASH. However, there's growing evidence to suggest that changing your lifestyle can really help. This includes things like eating a diet with fewer carbohydrates, getting more exercise, and losing a noticeable amount of weight. These changes have shown promise in improving NASH.

This particular study wants to see how effective a special 'formula diet' can be. Participants will follow this specific diet for 12 weeks as part of a lifestyle change. The aim is to understand if this dietary approach can improve the condition and offer a potential new way to manage NASH for patients.

Key takeaways

This study explores a special diet for a liver condition called NASH (fatty liver).
NASH is serious and currently has no standard treatment.
The study involves a 12-week 'formula diet' and nutritional advice.
Participation includes clinic visits over one year.
It aims to see if diet changes can improve liver health.
Both men and women aged 18-99 with a BMI over 25 can participate, as long as other conditions are met.

Who may be eligible?

To join this study, people need to be adults aged between 18 and 99 years old. You must have a body mass index (BMI) over 25, which means you are considered overweight or obese.

However, there are some reasons why you wouldn't be able to join. For example, if you have a history of drug or alcohol misuse, or if you have any other serious acute or long-term illnesses (apart from type 2 diabetes, which is allowed). Unfortunately, if you are pregnant or currently breastfeeding, you also won't be able to take part in this study.

Both men and women are welcome to participate, as long as they meet the other requirements.

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.

Are you between 18 and 99 years old?
Do you have a Body Mass Index (BMI) over 25?
Have you never had issues with drug or alcohol misuse?
Do you not have any other serious ongoing health conditions (besides type 2 diabetes)?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to join this study, you'll be part of a lifestyle change programme. You'll receive advice on nutrition and will follow a special 'formula diet' for 12 weeks. During this time, you will have several visits to the clinic.

You'll have an initial visit at the start of the study (called 'baseline'), then follow-up visits after 4 weeks and again after 12 weeks, which is when the special diet period ends. There will be one final check-up visit a year after you started, at 52 weeks. The total duration of your participation, including follow-up, will be around 52 weeks (one year).

Potential risks and benefits

Taking part in this study might offer potential benefits, such as improving your NASH condition through dietary changes, which could reduce the risk of more serious liver problems in the future. As with any study involving a special diet, there might be some temporary side effects or challenges with sticking to the plan, but these will be discussed with you. You have the right to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Düsseldorf Catholic Hospital Group
Verified postcode
Düsseldorf, Germany
Praxis Prof. Erhardt
Verified postcode
Wuppertal, Germany

Common questions

What is a 'formula diet'?

A formula diet usually means a specially prepared meal replacement, often in liquid form like shakes, designed to provide all the nutrients you need in controlled portions.

What does 'non-alcoholic steatohepatitis (NASH)' mean?

NASH is a liver condition where fat builds up in the liver, leading to inflammation and liver cell damage. It's often called 'fatty liver' and is not caused by heavy alcohol use.

Will I have to pay for the formula diet?

The information provided does not specify this. You should ask the study team if there are any costs involved.

How long will my involvement in the study last?

Your direct participation, including the diet and follow-up visits, will last for about one year.

Will I have to exercise as part of the study?

The study mentions lifestyle intervention and nutritional advice. While exercise is generally beneficial for NASH, the core intervention detailed here is the formula diet. Your specific activity recommendations will come from the study team.