NCT02568605

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2015

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 30, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 6, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed
Last Updated

November 2, 2022

Status Verified

October 1, 2022

Enrollment Period

4.3 years

First QC Date

September 30, 2015

Last Update Submit

October 31, 2022

Conditions

Non-alcoholic Fatty Liver Disease

Keywords

Dietary interventionPrebiotic fibreWeight lossGut microbiotaObesityLiver fatHepatic fibrosis

Outcome Measures

Primary Outcomes (3)

  • Change in Liver Fat

    Assessed via MRI

    24 weeks

  • Change in Liver Fibrosis

    Assessed via FibroScan (transient elastography)

    24 weeks

  • 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)

    24 weeks

Secondary Outcomes (8)

  • Change in Glucose Tolerance

    24 weeks

  • Change in Glycemic Control

    24 weeks

  • Change in Subjective Appetite

    24 weeks

  • Change in Satiety Hormones

    24 weeks

  • Change in Body Composition

    24 weeks

  • +3 more secondary outcomes

Study Arms (3)

Prebiotic Fibre

EXPERIMENTAL

The 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.

Dietary Supplement: Prebiotic fibreBehavioral: Weight Loss

Placebo

PLACEBO COMPARATOR

The 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.

Dietary Supplement: PlaceboBehavioral: Weight Loss

Weight Loss

OTHER

All participants will be supported through Registered Dietitian visits to achieve approximately 10% weight loss.

Behavioral: Weight Loss

Interventions

Prebiotic fibreDIETARY_SUPPLEMENT

Oligofructose-enriched inulin (Synergy1)

Prebiotic Fibre
PlaceboDIETARY_SUPPLEMENT

Maltodextrin

Placebo
Weight LossBEHAVIORAL

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.

PlaceboPrebiotic FibreWeight Loss

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • 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%

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Calgary

Calgary, Alberta, T2N 1N4, Canada

Location

Related Publications (2)

  • 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.

    PMID: 40172664DERIVED

  • 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.

    PMID: 26635079DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseWeight LossObesityFatty LiverLiver Cirrhosis

Condition Hierarchy (Ancestors)

Liver DiseasesDigestive System DiseasesBody Weight ChangesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesFibrosisPathologic Processes

Study Officials

  • Raylene A Reimer, PhD, RD

    University of Calgary

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 30, 2015

First Posted

October 6, 2015

Study Start

May 1, 2015

Primary Completion

August 1, 2019

Study Completion

August 1, 2022

Last Updated

November 2, 2022

Record last verified: 2022-10

Locations

CA(1)