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

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. Identifier: NCT03914495
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : February 24, 2021
Information provided by (Responsible Party):
Translational Research Institute for Metabolism and Diabetes, Florida

Brief Summary:
The purpose of this study is to investigate whether reprogramming the microbiome via soluble fiber supplementation will decrease liver fat in obese individuals.

Condition or disease Intervention/treatment Phase
NAFLD Dietary Supplement: Inulin Dietary Supplement: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: The Role of Microbiome Reprogramming on Liver Fat Accumulation
Actual Study Start Date : May 21, 2019
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Inulin

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.

Primary Outcome Measures :
  1. Absolute Change in Liver Fat [ Time Frame: 28 days ]
    Liver fat changes will be assessed by MRI-PDFF

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT03914495

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Contact: Recruitment Department 407-303-7100

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United States, Florida
Translational Research Institute for Metabolism and Diabetes Recruiting
Orlando, Florida, United States, 32804
Contact: Recruitment Department         
Sponsors and Collaborators
Translational Research Institute for Metabolism and Diabetes, Florida
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Principal Investigator: Karen Corbin, PhD Study Principal Investigator
Additional Information:

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Responsible Party: Translational Research Institute for Metabolism and Diabetes, Florida Identifier: NCT03914495    
Other Study ID Numbers: 1312439
First Posted: April 16, 2019    Key Record Dates
Last Update Posted: February 24, 2021
Last Verified: February 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Translational Research Institute for Metabolism and Diabetes, Florida:
hepatic steatosis