Non-Alcoholic Fatty Liver DiseaseNCT03184376
Histological Improvement of NASH With Prebiotic
A study testing Prebiotic oligofructose in people with Non-Alcoholic Fatty Liver Disease, run by University of Calgary.
Trial summary
This trial will investigate the therapeutic potential of a prebiotic supplement to improve histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty liver activity score (NAS) ≥ 5). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- Prebiotic oligofructose
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- 28 Feb 2012to 30 May 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Liver biopsy confirmed NASH (NAS score greater than or equal to 5)
- BMI >25 kg/m2 (Caucasians)
- >23 kg/m2 (Asians)
- History of Serum ALT >1.5X upper normal limit
- No changes in lipid-lowering or diabetes medication over previous three months
- Ability to provide informed consent
Who cannot join
- alcohol consumption >20g/day (women) or >30g/day (men)
- alternate etiology for abnormal liver enzymes
- decompensated liver disease
- use of orlistat, liraglutide, prebiotic, probiotic, or antibiotic within 3 months prior to enrollment
About this study
Official title: Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial
This trial will investigate the therapeutic potential of a prebiotic supplement to improve histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty liver activity score (NAS) ≥ 5). Participants will be randomized to receive oligofructose (8 g/day for 12 weeks and 16g/day for 24 weeks) or isocaloric placebo for 9 months. The primary outcome measure is the change in liver biopsy NAS score and the secondary outcomes include changes in body weight, body composition, glucose tolerance, serum lipids, inflammatory markers, and gut microbiota.
Read the detailed description
Oligofructose and maltodextrin are both white powders that taste and look the same. They were both package in individual foil packets. Participants were blinded to the treatment allocation. Adherence to supplement protocol was monitored throughout the study through direct questioning and counting unused supplement packages. Participants were asked to maintain their usual physical activity.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- Prebiotic oligofructose, Placebo maltodextrin
- Keywords
- Gut microbiota, Prebiotic, Liver biopsy, Oligofructose
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prebiotic oligofructoseDietary supplement
Powder format
Placebo maltodextrinDietary supplement
Powder format
| Study group | Role | What they receive |
|---|---|---|
| Prebiotic | Experimental | Prebiotic oligofructose (Orafti P95, Beneo-Orafti Inc., Tienen, Belgium) taken 8g orally per day for 12 weeks followed by 16g per day for 24 weeks. Receives: Dietary Supplement: Prebiotic oligofructose |
| Placebo | Placebo comparator | Placebo maltodextrin (isocaloric to prebiotic) taken 3.3g orally per day for 12 weeks followed by 6.6g per day for 24 weeks. Receives: Dietary Supplement: Placebo maltodextrin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological change
Nonalcoholic fatty liver disease activity score
Measured: 9 months
Secondary outcomes (10)
Body composition
Body lean and fat mass
Measured: 9 months
Body weight
Body weight measurement
Measured: 9 months
Glucose tolerance
Oral glucose tolerance test
Measured: 9 months
Gut microbiota
Intestinal microbiota composition
Measured: 9 months
Serum total cholesterol
Total cholesterol
Measured: 9 months
Serum LDL cholesterol
Low-density lipoprotein cholesterol
Measured: 9 months
Serum triglycerides
Triglycerides
Measured: 9 months
Serum HDL cholesterol
High-density lipoprotein cholesterol
Measured: 9 months
Serum IL-6
Interleukin-6
Measured: 9 months
Serum TNF-alpha
Tumor necrosis factor - alpha
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2017
- Study start28 Feb 2012
- Primary completion16 Dec 2015
- Study completion30 May 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind, placebo controlled, randomized trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Raylene Reimer, University of Calgary
- Investigators
- Raylene A Reimer, PhD, RD, Principal investigator, The University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03184376
- Sponsor's protocol ID
- E-23936
- Status last verified
- Jun 2017
- First submitted
- 8 Jun 2017
- Last updated
- 12 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Other researchers would need to make an individual inquiry.
Publications
Bomhof MR, Parnell JA, Ramay HR, Crotty P, Rioux KP, Probert CS, Jayakumar S, Raman M, Reimer RA. Histological improvement of non-alcoholic steatohepatitis with a prebiotic: a pilot clinical trial. Eur J Nutr. 2019 Jun;58(4):1735-1745. doi: 10.1007/s00394-018-1721-2. Epub 2018 May 19.
PubMed 29779170
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Improvement of Non-alcoholic Steatohepatitis With a Prebiotic: a Pilot Clinical Trial
- ClinicalTrials.gov ID
- NCT03184376
- Acronym / sponsor ID
- E-23936
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- Gut microbiota, Prebiotic, Liver biopsy, Oligofructose
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Study start
- 28 Feb 2012 (actual)
- Primary completion
- 16 Dec 2015 (actual)
- Study completion
- 30 May 2016 (actual)
- First posted
- 12 Jun 2017 (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.
This trial will investigate the therapeutic potential of a prebiotic supplement to improve histological parameters of NASH. In a single-blind, placebo controlled, randomized pilot trial will be conduced in individuals with liver biopsy confirmed NASH (Non-alcoholic fatty liver activity score (NAS) ≥ 5). Participants will be randomized to receive oligofructose (8 g/day for 12 weeks and 16g/day for 24 weeks) or isocaloric placebo for 9 months. The primary outcome measure is the change in liver biopsy NAS score and the secondary outcomes include changes in body weight, body composition, glucose tolerance, serum lipids, inflammatory markers, and gut microbiota.
Detailed description
Oligofructose and maltodextrin are both white powders that taste and look the same. They were both package in individual foil packets. Participants were blinded to the treatment allocation. Adherence to supplement protocol was monitored throughout the study through direct questioning and counting unused supplement packages. Participants were asked to maintain their usual physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind, placebo controlled, randomized trial
| Arm | Type | Receives |
|---|---|---|
| Prebiotic | Experimental | Dietary Supplement: Prebiotic oligofructosePrebiotic oligofructose (Orafti P95, Beneo-Orafti Inc., Tienen, Belgium) taken 8g orally per day for 12 weeks followed by 16g per day for 24 weeks. |
| Placebo | Placebo comparator | Dietary Supplement: Placebo maltodextrinPlacebo maltodextrin (isocaloric to prebiotic) taken 3.3g orally per day for 12 weeks followed by 6.6g per day for 24 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Liver biopsy confirmed NASH (NAS score greater than or equal to 5)
- BMI >25 kg/m2 (Caucasians)
- >23 kg/m2 (Asians)
- History of Serum ALT >1.5X upper normal limit
- No changes in lipid-lowering or diabetes medication over previous three months
Key exclusion criteria (4 listed)
- alcohol consumption >20g/day (women) or >30g/day (men)
- alternate etiology for abnormal liver enzymes
- decompensated liver disease
- use of orlistat, liraglutide, prebiotic, probiotic, or antibiotic within 3 months prior to enrollment
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 |
|---|---|---|
| Prebiotic oligofructosePowder format | Dietary supplement | Prebiotic |
| Placebo maltodextrinPowder format | Dietary supplement | Placebo |
Primary outcome
Histological change
Time frame: 9 months
Nonalcoholic fatty liver disease activity score
10 secondary outcomes
Body composition
Time frame: 9 months
Body weight
Time frame: 9 months
Glucose tolerance
Time frame: 9 months
Gut microbiota
Time frame: 9 months
Serum total cholesterol
Time frame: 9 months
Serum LDL cholesterol
Time frame: 9 months
Serum triglycerides
Time frame: 9 months
Serum HDL cholesterol
Time frame: 9 months
Serum IL-6
Time frame: 9 months
Serum TNF-alpha
Time frame: 9 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
- Derived from this study: PubMed 29779170Bomhof MR, Parnell JA, Ramay HR, Crotty P, Rioux KP, Probert CS, Jayakumar S, Raman M, Reimer RA. Histological improvement of non-alcoholic steatohepatitis with a prebiotic: a pilot clinical trial. Eur J Nutr. 2019 Jun;58(4):1735-1745. doi: 10.1007/s00394-018-1721-2. Epub 2018 May 19.
- Individual participant dataSharing planned: Undecided. Other researchers would need to make an individual inquiry.
Related trials for Non-Alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease
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. This study is not recruiting at the moment.
Raylene A Reimer, PhD, RD principal investigator
The University of Calgary
Questions about this trial
What is this clinical trial studying?
A study testing Prebiotic oligofructose in people with Non-Alcoholic Fatty Liver Disease, run by University of Calgary.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Histological change (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03184376, which also lists 1 linked publication.
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 Jun 2017.