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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05480696
Other study ID # 14888
Secondary ID 471270
Status Recruiting
Phase Phase 1
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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