Soluble Fibre Supplementation in NAFLD

NCT05480696 | Recruiting Phase 2

• 2 other identifiers: 14888471270
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Change in hepatic stiffness.

  Six months

• Change in glycemic control, or insulin resistance.

  Six months

• Change in liver enzymes (ALT, AST, GGT, or ALP)

  Six months

• Change in body fat percentage

  Six months

• Change in weight

  Six months

Other Outcomes (1)

• Changes in molecular profiling of gut microbiome

  Six months

Study Arms (2)

Oligofructose Inulin Supplementation

EXPERIMENTAL

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.

Dietary Supplement: Fructo-oligosaccharide enriched inulin supplement

Maltodextrin Supplementation

SHAM COMPARATOR

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).

Other: Maltodextrin

Interventions

Fructo-oligosaccharide enriched inulin supplement DIETARY_SUPPLEMENT

Experiment

Oligofructose Inulin Supplementation

Maltodextrin OTHER

Placebo.

Maltodextrin Supplementation

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify 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 measured as part of clinic enrolment).

You may not qualify 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, 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

Sponsors & Collaborators

• McMaster University: lead

Study Sites (1)

McMaster University Medical Center

Hamilton, Ontario, L8S4K1, Canada

RECRUITING

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Fatty Liver

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases

Study Officials

• Nikhil Pai, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paige AL Cheveldayoff, BSC

CONTACT

3063611281; cheveldp@mcmaster.ca

Nikhil Pai, MD

CONTACT

2892082457; pain@mcmaster.ca

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants will be randomly allocated (1:1) to the OF+INU supplementation (intervention) or placebo group in a concealed fashion using REDCap databases, generated by a computer algorithm in permuted blocks of 2 and 4, to avoid imbalances. Study investigators and participants will be blinded to group allocation.

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 29, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: November 12, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)