RecruitingNAINTERVENTIONAL

Time-restricted Feeding in MASLD

This research study is looking into a lifestyle change called time-restricted feeding for people with a common liver condition known as MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease). MASLD is usually treated with diet and exercise. This study focuses on a specific type of eating pattern where you eat normally for five days and then significantly reduce your food intake for two non-consecutive days each week. Scientists believe this type of eating might help with weight, how your body uses sugar, and reduce inflammation. The study will compare this special eating plan to a standard healthy diet to see if it helps improve MASLD and overall health for people aged 18 to 75 with a BMI over 25.

At a glance

Status

Recruiting

Phase

Sponsor

Universität des Saarlandes

Enrolment target

120

Start

15 Oct 2025

Estimated completion

15 May 2029

Metabolic Associated-dysfunction Steatotic Liver Disease (MASLD)

What is this study about?

This research study is about a common liver condition called MASLD. MASLD means there's too much fat in your liver, and it can be linked to other health issues like being overweight or having problems with how your body handles sugar. Currently, the best way to manage MASLD is by making changes to your lifestyle, like eating healthier and being more active.

This study wants to explore a specific healthy eating approach called 'time-restricted feeding,' sometimes known as intermittent fasting. In this plan, you eat normally for most days but then greatly reduce what you eat for a couple of days each week. Previous research has hinted that this way of eating might help with weight, improve how your body uses insulin (which controls blood sugar), and reduce swelling or inflammation in the body. We want to see if this particular eating pattern can help people with MASLD.

To do this, we'll ask everyone to first learn about general healthy eating based on German guidelines. After two weeks, people will be put into one of two groups by chance. One group will follow the 5:2 time-restricted eating plan, where they eat normally for five days and then have a very low calorie intake (around 600 calories) on two separate days. The other group will simply follow a healthy diet without any specific rules about when they eat or how much.

Key takeaways

This study looks at how a specific eating plan, 5:2 time-restricted feeding, affects the liver condition MASLD.
Participants will follow either the 5:2 plan or a general healthy diet.
The 5:2 plan involves eating normally for five days and consuming about 600 calories on two non-consecutive days.
The study aims to see if this method helps improve MASLD, body weight, and overall health.
You won't be given any new medicines as part of this research, it's all about diet.
You have the right to leave the study at any point if you change your mind.

Who may be eligible?

To join this study, you need to be aged between 18 and 75 years old and have a body mass index (BMI) over 25, which generally means you are overweight or obese. You also need to have been diagnosed with MASLD, which is a condition where fat builds up in your liver, but without other serious liver damage or stiffness. It's important that you understand what the study involves and are able to give your clear agreement to take part.

There are some reasons why you might not be able to join. For example, if you have certain serious liver conditions or other diseases like specific cancers, autoimmune conditions, or uncontrolled diabetes. You also can't take part if you drink more than a small amount of alcohol daily, are pregnant, or are taking certain medications that can affect the liver. If your weight has changed a lot recently or you're already on a very strict diet, you might not be suitable either.

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 75 years old?
Do you have a Body Mass Index (BMI) above 25?
Have you been diagnosed with MASLD (fatty liver) but without advanced liver scarring?
Do you understand what doing the study involves and can you give your clear consent?
Do you consume less than 20g (women) or 30g (men) of alcohol per day?
Are you NOT pregnant and do NOT have uncontrolled diabetes or other severe medical conditions listed?

Answer every question to see your result.

What does participation involve?

If you join this study, you will first receive information and guidance on general healthy eating for two weeks. After this, you will be assigned by chance to one of two groups. One group will follow a 5:2 time-restricted eating plan, meaning you'll eat normally for five days, and then for two non-consecutive days each week, you'll limit your food intake to around 600 calories. The other group will simply follow a healthy diet without specific timing or calorie limits. We don't specify the total number of visits or the duration of the study, but typically these kinds of studies involve regular check-ups, probably at the start, during, and at the end of the research. You won't be given any new medications as part of this study; it focuses on dietary changes. The full length of the study isn't stated, but diet studies often last several months.

Potential risks and benefits

There are potential benefits to taking part in this study, such as receiving expert guidance on healthy eating, which could lead to improvements in your MASLD and overall health, including weight loss and better blood sugar control. However, there are also potential risks. Following a very low-calorie diet for two days a week might make you feel tired, hungry, or have low energy. As with any study involving dietary changes, there's a small chance of unexpected side effects. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Department of Internal Medicine II, Saarland University Medical Center, Saarland University,
Verified postcode
Homburg, Germany· Recruiting

Common questions

What is MASLD?

MASLD stands for Metabolic dysfunction-Associated Steatotic Liver Disease. It's a common condition where too much fat builds up in your liver, often linked to being overweight or having problems with blood sugar.

What is 5:2 time-restricted feeding?

It's an eating pattern where you eat normally for five days a week, and then on two separate days, you significantly reduce what you eat to about 600 calories.

Will I be told what to eat?

You'll receive guidance on general healthy eating. If you're in the 5:2 group, you'll also get specific advice for the two low-calorie days, but you'll generally choose your own foods within the guidelines.

Will I have to take new medicines?

No, this study focuses on changes to your diet and eating patterns, not on giving you new medications.

How long will the study last?

The information provided doesn't state the exact duration, but diet studies often last for several months to properly assess the effects of the eating plan.

How to find out more

Ute M Stern

ute.stern@uni-saarland.de + 49 6841 16 15863 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.