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

University of Calgary

Status

Completed

Conditions

Non-alcoholic Fatty Liver Disease

Treatments

Dietary Supplement: Prebiotic fibre

Dietary Supplement: Placebo

Behavioral: Weight Loss

Study type

Interventional

Funder types

Other

Identifiers

NCT02568605

UC-REB14-2464

Details and patient eligibility

About

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.

Full 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.

Enrollment

45 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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%

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

45 participants in 3 patient groups, including a placebo group

Prebiotic Fibre

Experimental group

Description:

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.

Treatment:

Behavioral: Weight Loss

Dietary Supplement: Prebiotic fibre

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Behavioral: Weight Loss

Dietary Supplement: Placebo

Weight Loss

Other group