AuthorisedTherapeutic use (Phase IV)Interventional

Effect of Mediterranean diet combined with intermittent fasting on liver fibrosis compared to naltrexone/bupropion (Mysimba) in people with cardiometabolic risk factors

This study is investigating two different ways to help people with obesity or other weight-related health conditions improve their liver health. One group of participants will follow a Mediterranean diet combined with intermittent fasting, which means eating only during certain hours. The other group will take a specific medication called Mysimba. Researchers want to see which approach works better at reducing liver scarring, also known as liver fibrosis, over a six-month period. They will measure liver stiffness using a special scan called FibroScan, which is a non-invasive way to check liver health. The study also looks at other health markers like cholesterol, blood sugar, and overall well-being. Both men and women aged 18 and older are invited to participate.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Sint Franciscus Vlietland Groep Stichting

Enrolment target

Start

30 Jan 2025

People with a Body Mass Index (BMI) of 30 kg/m2 or more (obese)or 27 kg/m2 to 30 kg/m2 in the presence of one or more weight-related comorbidities (e.g. type 2 diabetes dislipidaemia or regulated hypertension)

What is this study about?

This research study is designed for adults who are overweight or obese and also have other health issues linked to their weight, such as type 2 diabetes, high cholesterol, or high blood pressure. Many people in this situation can develop problems with their liver, such as liver scarring (called fibrosis), which can impact their overall health if not addressed.

The study aims to compare two different strategies that might help improve liver health. One strategy involves lifestyle changes: following a Mediterranean style of eating — which includes lots of fruits, vegetables, healthy fats, and whole grains — combined with intermittent fasting, where you eat your meals within a certain time window each day. The other strategy involves taking a specific medication called Mysimba, which is sometimes prescribed to help with weight management.

The main goal is to see which of these approaches is more effective at reducing liver scarring over six months. Researchers will use a special, comfortable scan called FibroScan to measure how stiff your liver is, which tells them about the level of scarring. They will also look at many other aspects of your health, including your weight, cholesterol levels, blood sugar, and general well-being, to get a full picture of how each approach affects your body. This research is important because it could help doctors and patients understand the best ways to manage liver health in people with weight-related conditions.

Key takeaways

This study compares a special diet with a medicine for liver health.
It's for people who are overweight or obese with related health issues.
The main aim is to see which approach reduces liver scarring (fibrosis).
Liver health will be checked using a painless scan called FibroScan.
The study lasts for six months and involves regular health checks.

Who may be eligible?

This study is looking for adults who are at least 18 years old and do not have an upper age limit. Both men and women can take part.

To be eligible, you need to have a Body Mass Index (BMI) of 30 or higher, which is typically classified as obese. If your BMI is slightly lower, between 27 and 30, you might still be able to join if you also have at least one other weight-related health condition. These conditions could include type 2 diabetes, high cholesterol, or high blood pressure that is being managed by medication.

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 18 years old or older?
Is your BMI 30 or higher, OR between 27 and 30 with conditions like diabetes, high cholesterol, or treated high blood pressure?
Are you able to commit to a 6-month study with regular check-ups?
Are you comfortable with potentially following a specific diet plan or taking a study medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be in the study for a total of six months. During this time, you will have regular visits to the clinic where researchers will check your health. Depending on which group you are assigned to, you will either follow a specific diet plan (Mediterranean diet with intermittent fasting) or take the Mysimba medication regularly.

Assessments will include regular measurements like your weight, height, and waist size. You will also have blood tests to check things like your cholesterol, blood sugar, and other markers related to your liver and general health. A special scan called FibroScan will be used to measure your liver stiffness and fat content, which is quick and painless. You might also be asked to fill out questionnaires about your food intake, physical activity, and how you feel about your quality of life. The research team will explain everything thoroughly before you start.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and potential risks. You might find that one of the interventions helps improve your liver health and overall well-being, or you might gain a better understanding of your health. However, there's no guarantee that you will personally benefit from participating. There could be side effects from the medication, or the diet and fasting might be challenging to stick to. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Netherlands

Common questions

What is liver fibrosis?

Liver fibrosis is when scar tissue builds up in your liver. It can happen due to various health issues and, if it gets worse, can affect how well your liver works.

What is a FibroScan?

A FibroScan is a quick, non-invasive scan that measures how stiff your liver is. This helps doctors understand if there’s any scarring or fat buildup in your liver without needing a biopsy.

What is intermittent fasting?

Intermittent fasting means you eat all your meals within a specific window of time each day, for example, only between 12 PM and 8 PM, and you don't eat outside of those hours.

What is Mysimba?

Mysimba is a prescribed medication that combines two active ingredients (naltrexone and bupropion) and is sometimes used to help people with weight management.

Will I know which treatment I'm getting?

The study design will determine whether you know which treatment you are receiving (diet or medication). The research team will explain this to you clearly during the consent process.