Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
60 participants
INTERVENTIONAL
2022-09-09
2027-03-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Oligofructose Inulin Supplementation
The intervention group will receive a daily fibre supplementation of (fructo-oligosaccharide enriched inulin, 4g twice daily; Orafti®Synergy1, BENEO), a tasteless white powder contained within a tear-able, partitioned 4g sachet, sprinkled and dissolved in 125 mL of water.
Fructo-oligosaccharide enriched inulin supplement
Experiment
Maltodextrin Supplementation
The control group will receive a daily supplementation of carbohydrate placebo (isocaloric maltodextrin), identical in colour, packaging, preparation, and dose (4g, twice daily; C\*Dry MD™,Cargill).
Maltodextrin
Placebo.
Interventions
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Fructo-oligosaccharide enriched inulin supplement
Experiment
Maltodextrin
Placebo.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
8 Years
17 Years
ALL
No
Sponsors
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McMaster University
OTHER
Responsible Party
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Principal Investigators
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Nikhil Pai, MD
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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McMaster University Medical Center
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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471270
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
14888
Identifier Type: -
Identifier Source: org_study_id
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