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.|
|ClinicalTrials.gov Identifier: NCT03914495|
Recruitment Status : Recruiting
First Posted : April 16, 2019
Last Update Posted : February 24, 2021
|Condition or disease||Intervention/treatment||Phase|
|NAFLD||Dietary Supplement: Inulin Dietary Supplement: Placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|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|
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.
- Absolute Change in Liver Fat [ Time Frame: 28 days ]Liver fat changes will be assessed by MRI-PDFF
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): NCT03914495
|Contact: Recruitment Departmentemail@example.com|
|United States, Florida|
|Translational Research Institute for Metabolism and Diabetes||Recruiting|
|Orlando, Florida, United States, 32804|
|Contact: Recruitment Department|
|Principal Investigator:||Karen Corbin, PhD||Study Principal Investigator|