Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02568605
Recruitment Status : Recruiting
First Posted : October 6, 2015
Last Update Posted : September 19, 2018
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Raylene Reimer, University of Calgary

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Dietary Supplement: Prebiotic fibre Dietary Supplement: Placebo Behavioral: Weight Loss Not Applicable

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prebiotic Fibre Supplementation and Gut Microbiota in Non-alcoholic Fatty Liver Disease
Study Start Date : May 2015
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : August 2020


Arm Intervention/treatment
Experimental: Prebiotic Fibre
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 fibre
Oligofructose-enriched inulin (Synergy1)

Behavioral: Weight Loss
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.

Placebo Comparator: Placebo
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: Placebo
Maltodextrin

Behavioral: Weight Loss
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.

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




Primary Outcome Measures :
  1. Change in Liver Fat [ Time Frame: 24 weeks ]
    Assessed via MRI

  2. Change in Liver Fibrosis [ Time Frame: 24 weeks ]
    Assessed via FibroScan (transient elastography)

  3. Change in Liver Injury [ Time Frame: 24 weeks ]
    Assessed via Fibrotest Score (composite score from serum biochemical markers: alfa2-macroglobulin, apolipoproteinA1, total bilirubin, haptoglobin, gamma glutamyl transpeptidase, alanine aminotransferase)


Secondary Outcome Measures :
  1. Change in Glucose Tolerance [ Time Frame: 24 weeks ]
    Assessed via an oral glucose tolerance test

  2. Change in Glycemic Control [ Time Frame: 24 weeks ]
    Assessed via HbA1c

  3. Change in Subjective Appetite [ Time Frame: 24 weeks ]
    Assessed via Subjective appetite ratings on a visual analogue scale

  4. Change in Satiety Hormones [ Time Frame: 24 weeks ]
    Assessed in serum as pg/ml (Ghrelin, Glucagon-like peptide-1, Glucose-dependent insulinotropic polypeptide, leptin and Peptide tyrosine tyrosine)

  5. Change in Body Composition [ Time Frame: 24 weeks ]
    Assessed via dual x-ray absorptiometry

  6. Change in Quality of Life [ Time Frame: 24 weeks ]
    Assessed via the Short Form-36v2 Health Survey questionnaire

  7. Dietary Adherence [ Time Frame: 24 weeks ]
    Assessed via adherence to prescribed versus measured energy intake assessed by food records

  8. Examine mechanisms related to prebiotic-induced changes in gut microbiota, their metabolic byproducts, and de novo lipogenesis [ Time Frame: 24 weeks ]
    Via investigating gut microbiota shot-gun sequencing and measurement of volatile organic compounds and de novo lipogenesis using deuterium incorporation



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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%

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02568605


Contacts
Layout table for location contacts
Contact: Raylene A Reimer, PhD, RD 403-220-8218 reimer@ucalgary.ca

Locations
Layout table for location information
Canada, Alberta
University of Calgary Recruiting
Calgary, Alberta, Canada, T2N 1N4
Contact: Raylene A Reimer, PhD, RD    403-220-8218    reimer@ucalgary.ca   
Sponsors and Collaborators
University of Calgary
Canadian Institutes of Health Research (CIHR)
Investigators
Layout table for investigator information
Principal Investigator: Raylene A Reimer, PhD, RD University of Calgary

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Raylene Reimer, Professor, University of Calgary
ClinicalTrials.gov Identifier: NCT02568605     History of Changes
Other Study ID Numbers: UC-REB14-2464
First Posted: October 6, 2015    Key Record Dates
Last Update Posted: September 19, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Raylene Reimer, University of Calgary:
Dietary intervention
Prebiotic fibre
Weight loss
Gut microbiota
Obesity
Liver fat
Hepatic fibrosis
Additional relevant MeSH terms:
Layout table for MeSH terms
Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Digestive System Diseases