RecruitingPHASE2INTERVENTIONAL

Soluble Fibre Supplementation in NAFLD

The FIND study is exploring whether a daily fibre supplement, made of oligofructose and inulin, can help children aged 8 to 17 who have non-alcoholic fatty liver disease. This condition means there is too much fat in the liver. Some children will take the fibre supplement, while others will take a dummy pill (placebo) for six months. This is a "double-blind" study, meaning neither the participants nor the doctors will know who is getting the real supplement. Doctors will monitor liver fat using special MRI scans, check blood samples, analyse diets, and measure body changes at different times during the study. The aim is to see if the fibre can improve liver health in these children.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

McMaster University

Enrolment target

Start

09 Sep 2022

Estimated completion

01 Mar 2027

Non-Alcoholic Fatty Liver Disease Non Alcoholic Steatohepatitis Hepatic Steatosis

What is this study about?

The FIND study is all about understanding if a special type of fibre, taken as a daily supplement, can help children and teenagers with a condition called non-alcoholic fatty liver disease (NAFLD). This condition means that too much fat has built up in the liver, even if the person doesn't drink alcohol. It's becoming more common, especially in young people, and doctors are looking for ways to help manage it.

In this study, researchers want to see if adding certain fibres, called oligofructose and inulin, to a child's daily routine can make a difference. These are the same types of helpful fibres you might find in some fruits, vegetables, and whole grains. They're hoping this supplement might help reduce the amount of fat in the liver and improve overall health.

The study involves giving some children the active fibre supplement and others a "dummy pill" (called a placebo). This helps researchers compare the results fairly. Neither the children nor the study team will know who is getting which, to keep the results as unbiased as possible. Over six months, they'll closely monitor various health markers to understand the effects.

Key takeaways

The FIND study investigates a fibre supplement for children with fatty liver disease.
Children aged 8-17 who meet specific health criteria can potentially join.
Participants will take either a fibre supplement or a dummy pill daily for six months.
Regular health checks, including MRI scans and blood tests, will be part of the study.
The study aims to see if the fibre can reduce fat in the liver.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join the FIND study, children must be between 8 and 17 years old. They need to have been diagnosed with obesity and must be a patient at the GHWM Clinic. Importantly, they must also show signs of non-alcoholic fatty liver disease, which means their liver blood test (ALT) is high and a scan has shown they have fat in their liver.

There are also some reasons why a child might not be able to join. For example, if they have certain types of diabetes (Type 1 or Type 2), they wouldn't be eligible. Also, if they can't have an MRI scan – for instance, due toclaustrophobia, a metal implant, or being over a certain weight (300lbs) – they wouldn't be able to participate, as MRI is key for measuring liver fat.

Other reasons for not being able to take part include already using other fibre supplements, taking certain medications that affect liver fat, having another known liver condition, or being allergic to the supplement ingredients. Children who regularly drink alcohol (more than 7 drinks per week or 3 per day) also cannot join.

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.

Is your child aged between 8 and 17?
Has your child been diagnosed with obesity?
Is your child a patient at the GHWM Clinic?
Has your child had blood tests showing high liver enzymes (ALT) and a scan showing fat in their liver?
Does your child have any medical conditions like Type 1 or Type 2 diabetes?
Can your child have an MRI scan (no claustrophobia, metal implants, or tattoos from the last year)?

Answer every question to see your result.

What does participation involve?

If your child takes part in the FIND study, they will be asked to either take a special fibre supplement or a dummy pill (placebo) twice a day for six months. This supplement will be given in powder form, to be mixed in water or food.

Over these six months, your child will have study visits at the start, after 3 months, and again at 6 months. These visits will involve various checks, including blood tests, special MRI scans to measure liver fat and stiffness, and body measurements like height and weight. Your child will also be asked to fill in questionnaires about their diet and general health. Throughout the study, the team will send text messages and make calls to check in, answer questions, and help ensure your child is taking the supplement as planned.

Potential risks and benefits

Participating in research always has potential benefits and risks. Your child might benefit from closer monitoring of their liver health and overall well-being. If the fibre supplement works, it could help reduce liver fat. However, it's also possible that the supplement may not help, or your child might receive the dummy pill. Like any supplement or medication, there's a small chance of side effects, though the study team will monitor for them. You and your child are entirely free to withdraw from the study at any time, for any reason, without it affecting your child's usual medical care.

Locations (1)

McMaster University Medical Center
Verified postcode
Hamilton, Canada· Recruiting

Common questions

What is non-alcoholic fatty liver disease?

It's a condition where too much fat builds up in the liver, not caused by alcohol. It's becoming more common in children.

What is the fibre supplement made of?

It's a mix of special fibres called oligofructose and inulin, which are found naturally in some plants.

Why will some children get a 'dummy pill'?

This helps doctors compare the results fairly. It lets them see if the real supplement is truly making a difference compared to getting no active treatment.

How long will my child be in the study?

Your child will take the supplement for six months and have study appointments over that period.

Will we know if my child is getting the fibre or the dummy pill?

No, this is a 'blinded' study, meaning neither you nor the doctors will know during the study. This helps keep the results unbiased.

How to find out more

Paige AL Cheveldayoff, BSC

cheveldp@mcmaster.ca 3063611281 Official trial record

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