Non-Alcoholic Fatty Liver DiseasePhase 2FINDNCT05480696
Soluble Fibre Supplementation in NAFLD
A Phase 2 study testing Fructo-oligosaccharide enriched inulin supplement and Maltodextrin in people with Non-Alcoholic Fatty Liver Disease and Non Alcoholic Steatohepatitis, run by McMaster University at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 8 to 17 years
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease, Non Alcoholic Steatohepatitis, Hepatic Steatosis
- What is being tested?
- Fructo-oligosaccharide enriched inulin supplement and Maltodextrin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 9 Sep 2022to Mar 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
McMaster University Medical Center
Hamilton, Ontario, L8S4K1
Paige Cheveldayoff, BSc, 306-361-1281, cheveldp@mcmaster.ca
Nikhil Pai, MD, 905.521.2100 ext. 73587, pain@mcmaster.ca
About this study
Official title: The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
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.
Read the detailed 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
- Being tested
- Fructo-oligosaccharide enriched inulin supplement, Maltodextrin
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Fatty Liver
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fructo-oligosaccharide enriched inulin supplementDietary supplement
Experiment
MaltodextrinOther
Placebo.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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). Receives: Other: Maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Six months
Secondary outcomes (7)
Change in hepatic stiffness.
Hepatic stiffness, a measure of hepatic fibrosis, will be measured via MRI using standard techniques.
Measured: Six months
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).
Measured: Six months
Change in liver enzymes (ALT, AST, GGT, or ALP)
Liver enzymes will be measured using Abbott ARCHITECT Systems
Measured: Six months
Change in body fat percentage
Body fat will be measured using a DXA scanner, by research team members previously trained in DXA measurement.
Measured: Six months
Change in weight
Weight will be measured using an electronic platform scale.
Measured: Six months
Change in height
Height will be measured using a wall mounted stadiometer.
Measured: Six months
Change in BMI
BMI will be calculated mathematically from other outcomes such as height and weight.
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2022
- Study start9 Sep 2022
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nikhil Pai, MD, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05480696
- Sponsor's protocol ID
- 14888
- Other IDs
- 471270
- Acronym
- FIND
- Status last verified
- Nov 2024
- First submitted
- 22 Jul 2022
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Soluble Fibre Supplementation for the Treatment of Pediatric Non-alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT05480696
- Acronym / sponsor ID
- FIND / 14888
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Study start
- 9 Sep 2022 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Oligofructose Inulin Supplementation | Experimental | Dietary Supplement: Fructo-oligosaccharide enriched inulin supplementThe 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. |
| Maltodextrin Supplementation | Sham comparator | Other: MaltodextrinThe 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). |
Who may qualify
- Ages
- 8 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fructo-oligosaccharide enriched inulin supplementExperiment | Dietary supplement | Oligofructose Inulin Supplementation |
| MaltodextrinPlacebo. | Other | Maltodextrin Supplementation |
Primary outcome
Change in hepatic fat content.
Time frame: Six months
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.
7 secondary outcomes
Change in hepatic stiffness.
Time frame: Six months
Change in glycemic control, or insulin resistance.
Time frame: Six months
Change in liver enzymes (ALT, AST, GGT, or ALP)
Time frame: Six months
Change in body fat percentage
Time frame: Six months
Change in weight
Time frame: Six months
Change in height
Time frame: Six months
Change in BMI
Time frame: Six months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Nikhil Pai, MD principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fructo-oligosaccharide enriched inulin supplement and Maltodextrin in people with Non-Alcoholic Fatty Liver Disease and Non Alcoholic Steatohepatitis, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paige AL Cheveldayoff, BSC (3063611281, cheveldp@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in hepatic fat content. (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.