Soluble Fibre Supplementation in NAFLD

Non-Alcoholic Fatty Liver Disease Clinical Trial

— FIND  

Official title:

The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05480696
• Other study ID #: 14888
• Secondary ID: 471270
• Status: Recruiting
• Phase: Phase 1
• Start date: September 9, 2022
• Est. completion date: March 2027

Study information

• Verified date: March 2023
• Source: McMaster University
• Contact: Paige AL Cheveldayoff, BSC
• Phone: 3063611281
• Email: cheveldp[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The FIND study will look at the effect of a nutritional mixed fibre supplement, oligofructose and inulin (OF+INU), on children with non-alcoholic fatty liver disease. In this randomized, double- blind controlled trial, subjects will be given a supplement, in the form of oral pills, and will have bloodwork performed, their diets analyzed, and liver fat measured at several timepoints. Liver fat will be measured by using a specialized MRI device located at St. Joseph's Hospital. Subjects will be recruited from the Children's Exercise and Nutrition Clinic.

Description:

The FIND (Fibre in Non-Alcoholic Fatty Liver Disease) study will be a single-centre, randomized, double-blind placebo-controlled trial comparing the effects of 6 months of mixed oligofructose and inulin (OF+INU) supplementation vs placebo on hepatic fat content, hepatic stiffness, metabolic outcomes, and body composition in children ages 8-17 years old. Assessments such as MRI measurements of hepatic fat and hepatic stiffness, anthropometry and pubertal status questionnaires, and other investigations such as body composition via dual energy X-ray absorptiometry (DXA), fasting lipids, liver enzymes, blood glucose and oral-glucose tolerance (OGTT) tests will be performed; and randomization will be conducted via REDCap software. Eighty participants will be enrolled for baseline evaluation in order to randomize sixty participants for the intervention phase (i.e. thirty participants per study group). Participants will consume one packet (4g) of OF+INU or placebo (Maltodextrin) daily. If tolerated, this will increase to one packet twice daily. Several strategies will be implemented to increase compliance, including text message reminders (daily for first week, then weekly), study calls to assess compliance and tolerability, and check-ins with participants at each clinic visit. These interactions will allow the study team to assess challenges and offer prompt support. Compliance will be assessed at each study visit by counting empty and unused sachets. Treatment with OF+INU or placebo will occur for 6 months, with study visits being conducted at baseline evaluation, 3 months and 6 months

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2027
• Est. primary completion date: March 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

Inclusion 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).

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Fatty Liver
• Hepatic Steatosis
• Liver Diseases
• Non Alcoholic Steatohepatitis
• Non-Alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• Fructo-oligosaccharide enriched inulin supplement
Experiment

Other:
• Maltodextrin
Placebo.

Locations

Country	Name	City	State
Canada	McMaster University Medical Center	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in molecular profiling of gut microbiome	Profiling of the gut microbiome will be measured from collected stool samples	Six months
Primary	Change in hepatic fat content.	Hepatic fat content will be measured via MRI at baseline and 6-months using standard techniques, optimized for accuracy, precision and reproducibility of proton density fat fraction (PDFF) quantification.	Six months
Secondary	Change in hepatic stiffness.	Hepatic stiffness, a measure of hepatic fibrosis, will be measured via MRI using standard techniques.	Six months
Secondary	Change in glycemic control, or insulin resistance.	Measured using plasma glucose (fasting and + 2 hours following oral glucose load) and HbA1c from a 2-hour OGTT (1.75g/kg, up to maximum of 75g glucose administered).	Six months
Secondary	Change in liver enzymes (ALT, AST, GGT, or ALP)	Liver enzymes will be measured using Abbott ARCHITECT Systems	Six months
Secondary	Change in body fat percentage	Body fat will be measured using a DXA scanner, by research team members previously trained in DXA measurement.	Six months
Secondary	Change in weight	Weight will be measured using an electronic platform scale.	Six months
Secondary	Change in height	Height will be measured using a wall mounted stadiometer.	Six months
Secondary	Change in BMI	BMI will be calculated mathematically from other outcomes such as height and weight.	Six months