Non-Alcoholic Fatty Liver Disease study: Maltodextrin
Official title Soluble Fibre Supplementation in NAFLD
ClinicalTrials.gov ID: NCT05480696
What this study is testing
- What it's testing
- The study aims to find out if taking a specific fiber supplement changes the amount of fat in the liver.
- Who it's for
- The study is looking for children who have non-alcoholic fatty liver disease.
- What's involved
- Participants will take daily fiber pills and visit the clinic for blood tests, diet reviews, and special MRI scans to measure liver fat.
- Time commitment
- The study involves several visits over time to track changes in liver fat and health.
- Phase 2: a mid-size study of how well it works
You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 17
You may be able to join if
- Children ages 8-17 years
- Diagnosed with obesity (BMI ≥2 standard deviations above WHO reference median)
- Enrolled in GHWM Clinic
- Clinical evidence of NAFLD (elevation of ALT, greater than 2x upper-limit-of-normal (ULN) [ALT\>80 IU/L for 8-17 years of age], and hepatic steatosis...
You likely can't join if
- Type 1, Type 2 diabetes mellitus (T1DM, T2DM)
- Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight \> 300lbs)
- Concomitant use of other fibre supplements
- Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants...
- Presence of another known cause of liver disease
- Known allergy or hypersensitivity to OF-INU supplementation
See the full eligibility criteria
- Children ages 8-17 years
- Diagnosed with obesity (BMI ≥2 standard deviations above WHO reference median)
- Enrolled in GHWM Clinic
- Clinical evidence of NAFLD (elevation of ALT, greater than 2x upper-limit-of-normal (ULN) [ALT\>80 IU/L for 8-17 years of age], and hepatic steatosis measured as part of clinic enrolment).
- Type 1, Type 2 diabetes mellitus (T1DM, T2DM)
- Contraindications to having MRI (claustrophobia, metal implant, recent tattoo, weight \> 300lbs)
- Concomitant use of other fibre supplements
- Medications known to affect hepatic fat content, taken within the past year (i.e., glucocorticoids, anabolic steroids, tetracycline, anticonvulsants, antipsychotics, glucose- lowering medications)
- Presence of another known cause of liver disease
- Known allergy or hypersensitivity to OF-INU supplementation
- Self-reported alcohol intake \>7 drinks/week or 3 drinks/day
The study team makes the final eligibility decision.
Where it is enrolling
- Hamilton, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Hamilton, Ontario, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.