Recruiting
Phase 2

Soluble Fibre

Sponsor:

McMaster University

Code:

NCT05480696

Conditions

Non-Alcoholic Fatty Liver Disease

Non Alcoholic Steatohepatitis

Hepatic Steatosis

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

Interventions

Fructo-oligosaccharide enriched inulin supplement

Maltodextrin

Study Details

Brief 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.

Conditions

Non-Alcoholic Fatty Liver Disease

Non Alcoholic Steatohepatitis

Hepatic Steatosis

Study ID

NCT05480696

Start date

Sep 9, 2022

Status verified date

Nov, 2024

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 17

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

sham comparator: 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).

Interventions

Fructo-oligosaccharide enriched inulin supplement

Experiment

Maltodextrin

Placebo.

Primary outcome measure

  • Change in hepatic fat content. [ Time Frame: Six months ]

Central Contacts and Locations

Central contacts

Paige AL Cheveldayoff, BSC

3063611281cheveldp@mcmaster.ca

Nikhil Pai, MD

2892082457pain@mcmaster.ca

Locations

McMaster University Medical Center

Recruiting

Hamilton, Ontario, Canada, L8S4K1

Contacts

Paige Cheveldayoff, BSc

306-361-1281cheveldp@mcmaster.ca

Nikhil Pai, MD

905.521.2100pain@mcmaster.ca

More Information

Sponsor

McMaster University

Last update posted

Nov 12, 2024

Last verified

Nov, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by McMaster University on 2024-11-12.