The Role of Microbiome Reprogramming on Liver Fat Accumulation (MILE)

February 10, 2023 updated by: AdventHealth Translational Research Institute
The purpose of this study is to investigate whether reprogramming the microbiome via soluble fiber supplementation will decrease liver fat in obese individuals.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

57

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Orlando, Florida, United States, 32804
        • Translational Research Institute for Metabolism and Diabetes

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age 35-65 years
  2. Magnetic Resonance Imaging Proton Density Fat Fraction (MRI-PDFF) 5%-30% (+0.5%)
  3. Liver stiffness <3.5 kPa by Magnetic Resonance Elastography (MRE)
  4. Body mass index (BMI) 27.5-45 kg/m2
  5. Weight stable (weight change of no more than 3 kg +0.5 kg) during the 6 months prior to enrollment
  6. For individuals with type 2 diabetes: HbA1c ≥6.5 - <9.5%. If taking allowable diabetes medications, HbA1c can be below 6.5%.
  7. Fasting triglycerides 400 mg/dL (4.5 mmol/L)
  8. Able to speak and understand written and spoken English
  9. Understands the procedures and agrees to participate by giving written informed consent
  10. Willing and able to comply with scheduled study days, laboratory tests, and other study procedures

Exclusion Criteria:

Acute or chronic medical conditions or medication that would contraindicate the participation in the research testing or could potentially affect metabolic function including, but not limited to:

  1. Diagnosis of type 1 diabetes mellitus
  2. Insulin use
  3. Change within 3 months of screening of any medication used to treat insulin resistance or type 2 diabetes
  4. History of regular alcohol consumption exceeding 14 drinks/week for females or 21 drinks/week for males within the previous 6 months (1 drink = 5 ounces [150 mL] of wine, 12 ounces [360 mL] of beer, or 1.5 ounces [45 mL] of hard liquor)
  5. A total score of 8 on the Alcohol Use Disorders Identification Test (AUDIT) questionnaire, indicating harmful or hazardous alcohol consumption
  6. Clinical evidence of hepatic decompensation, including, but not limited to esophageal varices, ascites, or hepatic encephalopathy

  7. Evidence of other forms of chronic liver disease (including laboratory tests and confirmed with a single repeat, if needed):

    • Hepatitis B virus: defined by presence of hepatitis B surface antigen
    • Hepatitis C virus: As defined by a clinical history of previous diagnosis of Hepatitis C (treated or untreated) or a positive Hepatitis C antibody.
    • Known diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis, autoimmune hepatitis, or overlap syndrome
    • Alcoholic liver disease
    • Known diagnosis of hemochromatosis
    • Prior known drug-induced liver injury
    • Known or suspected hepatocellular carcinoma or other liver cancer
    • History of liver transplant, current placement on a liver transplant list, or current model of end-stage liver disease (MELD) score >12
    • Histological presence of cirrhosis on a prior biopsy
  8. Bleeding disorders
  9. Acute or chronic infections
  10. Severe asthma or chronic obstructive pulmonary disease
  11. Renal insufficiency or nephritis
  12. Thyroid dysfunction (suppressed TSH, elevated TSH <10 µIU/ml if symptomatic or elevated TSH >10 µIU/ml if asymptomatic)
  13. Uncontrolled hypertension (BP >160 mmHg systolic or >100 mmHg diastolic)
  14. Prior or planned bariatric surgery
  15. Gastrointestinal disorders including: inflammatory bowel disease or malabsorption, swallowing disorders, suspected or known strictures, fistulas or physiological/mechanical GI obstruction, history of gastrointestinal surgery, Crohn's disease or diverticulitis.
  16. Participants with intolerance to soluble fiber, sucralose or erythritol.
  17. A positive urine drug test for illicit drugs
  18. History of major depression within <5 years from screening or which, in the opinion of a medical investigator, will impact the participant's ability to complete the study.
  19. History of eating disorders
  20. History of Cushing's disease or syndrome
  21. Untreated or inadequately controlled hypo- or hyperthyroidism
  22. Active rheumatoid arthritis or other inflammatory rheumatic disorder
  23. Pregnant or nursing females or females less than 6 months postpartum from the scheduled date of collection
  24. Nicotine use within the past 3 months
  25. Had major surgery within 4 weeks prior to Screening.
  26. Anemia (hemoglobin <12 g/dl in men, <11 g/dl in women) during screening
  27. Participation in studies involving investigational drug(s) within 30 days prior to Screening
  28. History or presence of cardiovascular disease (unstable angina, myocardial infarction or coronary revascularization within 6 months, presence of cardiac pacemaker, implanted cardiac defibrillator)
  29. Human Immunodeficiency Virus (HIV) infection defined as: previous diagnosis of HIV infection, history of positive screening or quantitative HIV testing; positive HIV screen
  30. Any malignancy not considered cured, except basal cell carcinoma and squamous cell carcinoma of the skin (a participant is considered cured if there has been no evidence of cancer recurrence in the previous 5 years)
  31. Use of drugs historically associated with non-alcoholic fatty liver disease (NAFLD) for 1 month in the previous year prior to Screening; examples include: amiodarone, methotrexate, systemic glucocorticoids, tetracyclines, tamoxifen, estrogens at doses greater than those used for hormone replacement, anabolic steroids, valproic acid, other known hepatotoxins
  32. Participants who fulfill any of the contraindications for MRI; examples include metal implants, devices, paramagnetic objects contained within the body and excessive or metal-containing tattoos
  33. Unable to participate in MR assessments due to physical limitations or equipment tolerances (e.g., MRI bore size and 500-pound weight limit) based on Investigator's judgment at screening
  34. Any person with history of severe claustrophobia or unable to lie still within the environment of the MRI scanner or unable maintain a breath hold for the required period to acquire images without mild sedation/treatment with an anxiolytic
  35. Blood donation (excluding plasma donations) of approximately 1 pint (500 mL) or more within 56 days prior to Screening (participants may not donate blood any time during the study, through the final study day)
  36. Presence of any condition that, in the opinion of the Investigator, compromises participant safety or data integrity or the participant's ability to complete study days

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Participants will receive powdered maltodextrin to provide equivalent calories and macronutrients without any fiber.
Dietary supplement: Placebo
Powdered maltodextrin will be provided in pre-weighed portions for consumption in a 1 week titration with a 21 day intervention at full dose.
ACTIVE_COMPARATOR: Inulin
Participants will receive inulin, 10 grams TID for 28 days with titration as follows: 10 grams QD for 3 days, 20 grams BID for 4 days with the remaining 21 days at 10 g TID.
Dietary supplement: Inulin
Powdered inulin will be provided in pre-weighed portions for consumption in a 1 week titration to reduce GI side effects with a 21 day intervention at full dose.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute Change in Liver Fat
Time Frame: 28 days
Liver fat changes will be assessed by MRI-PDFF
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth Translational Research Institute

Investigators

  • Principal Investigator: Karen Corbin, PhD, Study Principal Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 21, 2019

Primary Completion (ACTUAL)

June 2, 2021

Study Completion (ACTUAL)

June 9, 2021

Study Registration Dates

First Submitted

April 11, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (ACTUAL)

April 16, 2019

Study Record Updates

Last Update Posted (ACTUAL)

February 13, 2023

Last Update Submitted That Met QC Criteria

February 10, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1312439

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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