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Non-alcoholic Fatty Liver DiseaseNCT02568605

Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease

A study testing Prebiotic fibre and Weight Loss in people with Non-alcoholic Fatty Liver Disease, run by University of Calgary at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD. Part of the metabolic dysfunction may arise through changes in the gut microbiota. Read more about this study

Who is it for?
Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for
Non-alcoholic Fatty Liver Disease
What is being tested?
Prebiotic fibre and Weight Loss
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
45 participants
Where
1 siteCanada
Study dates
May 2015to Aug 2022
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 to 65 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult subjects diagnosed with NAFLD on the basis of abnormal liver enzymes (ALT>1.5x upper limit of normal) and ultrasonography
  • Exclusion of other causes of liver disease including viral hepatitis and alcoholic liver disease
  • Aspartate aminotransferase and alanine aminotransferase ≤10x upper limit of normal
  • Patients with type 2 diabetes treated with diet and exercise alone or metformin

Who cannot join

  • Cirrhosis of the liver (FibroScan >17.5 kilopascal or FibroTest >0.8) or clinical features of cirrhosis.
  • Alcohol consumption >20g/day (2 standard drinks) in women or > 30g/d (3 drinks) in men
  • Alternate (e.g. TPN) or concomitant etiology for abnormal liver enzymes.
  • History of decompensated liver disease including ascites, encephalopathy or variceal bleeding
  • Concomitant use of any weight loss medication, previous bariatric or other intestinal surgery
  • Presence of active infection, pregnancy or lactation
Show all 12Show fewer
  • Regular use of a probiotic or prebiotic supplement within 3 months prior to enrollment
  • Antibiotic use within 3 months prior to enrollment
  • Weight loss >3 kg within preceding 3 months to enrollment
  • Uncontrolled cardiovascular or respiratory disease, active malignancy, or chronic infections
  • Use of agents such as vitamin E, omega-3 fatty acids or medications with evidence for effects on NAFLD (pioglitazone, Glucagon-like peptide-1 analogues, dipeptidyl peptidase IV inhibitors, ursodeoxycholic acid)
  • Patients with type 2 diabetes where HbA1c is >9%

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • University of Calgary

    Calgary, Alberta, T2N 1N4

Other trials in Canada

About this study

Non-alcoholic fatty liver disease (NAFLD) is a condition where accumulation of fat in the liver leads to metabolic dysfunction. Currently there are no approved treatments for NAFLD. Part of the metabolic dysfunction may arise through changes in the gut microbiota. Prebiotic fibres have beneficial effects on glucose tolerance, body weight, and gut microbiota; therefore they may have potential as part of a dietary strategy for NAFLD treatment.

Read the detailed description

The main objective of this study is to assess the effect of prebiotic fibre supplementation, in conjunction with diet-induced weight loss, on reduction in liver fat and injury.

Primary Objective - determine the change in hepatic injury (fibrosis and inflammation) and hepatic fat (percent fat) over 6 months in NAFLD patients treated with prebiotic or placebo during weight loss.

Secondary Objectives - determine the changes in appetite, body composition, glycemic and insulinemic responses, quality of life with prebiotic or placebo during weight loss, and examine mechanisms related to prebiotic-induced changes in gut microbiota and lipogenesis.

Being tested
Prebiotic fibre, Placebo, Weight Loss
Keywords
Dietary intervention, Prebiotic fibre, Weight loss, Gut microbiota, Obesity, Liver fat, Hepatic fibrosis
Medical subject headings
Non-alcoholic Fatty Liver Disease, Weight Loss, Obesity, Fatty Liver, Liver Cirrhosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prebiotic fibreDietary supplement

    Oligofructose-enriched inulin (Synergy1)

  • PlaceboDietary supplement

    Maltodextrin

  • Weight LossBehavioural

    All participants will receive 10 one-on-one sessions with a Registered Dietitian designed to achieve 10% weight loss over 6 months. The sessions will focus on nutrition education and behavior counseling to reduce food intake and improve dietary quality.

Study groups in NCT02568605
Study groupRoleWhat they receive
Prebiotic FibreExperimentalThe intervention group will receive two 8g packets/day of prebiotic fibre to add to 250 ml of water and consume 30 minutes prior to breakfast and dinner.
Receives: Dietary Supplement: Prebiotic fibre; Behavioral: Weight Loss
PlaceboPlacebo comparatorThe control group will receive two 3g packets/day of maltodextrin to add to 250 ml of water and consume 30 minutes prior to breakfast and dinner.
Receives: Dietary Supplement: Placebo; Behavioral: Weight Loss
Weight LossOtherAll participants will be supported through Registered Dietitian visits to achieve approximately 10% weight loss.
Receives: Behavioral: Weight Loss

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Liver Fat

    Assessed via MRI

    Measured: 24 weeks

  2. Change in Liver Fibrosis

    Assessed via FibroScan (transient elastography)

    Measured: 24 weeks

  3. Change in Liver Injury

    Assessed via Fibrotest Score (composite score from serum biochemical markers: alfa2-macroglobulin, apolipoproteinA1, total bilirubin, haptoglobin, gamma glutamyl transpeptidase, alanine aminotransferase)

    Measured: 24 weeks

Secondary outcomes (8)

  1. Change in Glucose Tolerance

    Assessed via an oral glucose tolerance test

    Measured: 24 weeks

  2. Change in Glycemic Control

    Assessed via HbA1c

    Measured: 24 weeks

  3. Change in Subjective Appetite

    Assessed via Subjective appetite ratings on a visual analogue scale

    Measured: 24 weeks

  4. Change in Satiety Hormones

    Assessed in serum as pg/ml (Ghrelin, Glucagon-like peptide-1, Glucose-dependent insulinotropic polypeptide, leptin and Peptide tyrosine tyrosine)

    Measured: 24 weeks

  5. Change in Body Composition

    Assessed via dual x-ray absorptiometry

    Measured: 24 weeks

  6. Change in Quality of Life

    Assessed via the Short Form-36v2 Health Survey questionnaire

    Measured: 24 weeks

  7. Dietary Adherence

    Assessed via adherence to prescribed versus measured energy intake assessed by food records

    Measured: 24 weeks

  8. Examine mechanisms related to prebiotic-induced changes in gut microbiota, their metabolic byproducts, and de novo lipogenesis

    Via investigating gut microbiota shot-gun sequencing and measurement of volatile organic compounds and de novo lipogenesis using deuterium incorporation

    Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Oct 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionAug 2019
  4. Study completionAug 2022

Resources

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
45 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02568605
Sponsor's protocol ID
UC-REB14-2464
Status last verified
Oct 2022
First submitted
30 Sep 2015
Last updated
2 Nov 2022
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • Mayengbam S, Raman M, Parnell JA, Eksteen B, Lambert JE, Eller LK, Nicolucci AC, Aktary ML, Reimer RA. Effects of combined prebiotic fiber supplementation and weight loss counseling in adults with metabolic dysfunction-associated steatotic liver disease: a randomized controlled trial. Eur J Nutr. 2025 Apr 2;64(4):144. doi: 10.1007/s00394-025-03660-7.

    PubMed 40172664

  • Lambert JE, Parnell JA, Eksteen B, Raman M, Bomhof MR, Rioux KP, Madsen KL, Reimer RA. Gut microbiota manipulation with prebiotics in patients with non-alcoholic fatty liver disease: a randomized controlled trial protocol. BMC Gastroenterol. 2015 Dec 3;15:169. doi: 10.1186/s12876-015-0400-5.

    PubMed 26635079

Questions about this trial

What is this clinical trial studying?

A study testing Prebiotic fibre and Weight Loss in people with Non-alcoholic Fatty Liver Disease, run by University of Calgary 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 12 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 2 Nov 2022. 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.

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?

Change in Liver Fat (time frame: 24 weeks). The study lists 3 primary outcomes in all. 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 NCT02568605, which also lists 2 linked publications.

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 2 Nov 2022.

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