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Prebiotics in Patients With Non-alcoholic Liver Disease

Primary Purpose

Non-alcoholic Fatty Liver Disease, Metabolic Syndrome

Status
Active
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
ITF (Inulin/OFS 75/25)
Placebo
Sponsored by
Kaplan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring Inulin, OFS (oligofructose)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of NAFLD based on fatty infiltration detection by ultrasonography and alanine aminotransferase levels of (ALT) ≥ 30 U/L male ≥ 19 U/L females.
  • Over-weight (BMI ≥ 27 kg/m2) who fulfill the criteria of the National Cholesterol Education Program (NCEP) metabolic syndrome
  • Willing to sign informed consent to participate in the study
  • Patients without diabetes or with well-controlled diabetes (HbA1C < 7.5%) who are treated by diet ± metformin

Exclusion Criteria:

  • Pregnancy
  • Uncontrolled diabetes
  • Diabetic treatment other than metformin, unusual diets (vegetarian, vegan), usage of antibiotics, probiotics or prebiotics up to 6 months prior to study, alcohol abuse, presence of gastrointestinal or mental disorders, weight-loss treatment, bariatric surgery
  • Serious medical conditions
  • Evidence of another etiology for chronic liver disease such as: hepatitis B, hepatitis C, HIV, autoimmune diseases and metabolic diseases, medications with known hepatotoxicity.

Sites / Locations

  • Kaplan Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ITF (Inulin/OFS 75/25)

placebo

Arm Description

16 gram/day of ITF (Inulin/OFS 75/25)

16 gram/day of maltodextrin (placebo)

Outcomes

Primary Outcome Measures

Change from baseline in the severity of NAFLD
Determined by liver fat fraction measured by magnetic resonance spectroscopy (1H-MRS) Blood test for calculate Inflammation score using SteatoTest and NashTest (FibroMax™) Blood test for liver enzyme

Secondary Outcome Measures

Change from baseline of gut microbiota composition.
Quantitative evaluation of the change in the composition of bacteria from stool samples
Change from baseline in glycemic control
Determine by OGTT.
Change from baseline in insulin sensitivity
Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA).
Change from baseline in lipid profile
Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL

Full Information

First Posted
December 13, 2015
Last Updated
September 4, 2021
Sponsor
Kaplan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02642172
Brief Title
Prebiotics in Patients With Non-alcoholic Liver Disease
Official Title
A Randomized, Double - Blind Study With Two Parallel Arms for 4 Months (20 Weeks), Evaluating the Effectiveness of the Prebiotics in Patients With Non-alcoholic Liver Disease.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 2016 (Actual)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kaplan Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this present study is to evaluating whether prebiotics - ITF (Inulin/OFS 75/25) is effective in treating patients with non-alcoholic liver disease.
Detailed Description
The study will include 60 patients with Non-alcoholic fatty liver disease (NAFLD) which will randomize to two groups, receiving either ITF (Inulin/oligofructose-OFS 75/25) or maltodextrin (placebo). The trial will last for 26 weeks: Stage 1-Run-in period: Subjects will be followed to ascertain weight maintenance. Stage 2- Randomized intervention period: Subjects will be assigned to receive 16 gram/day of ITF or maltodextrin. Both ITF and placebo will be provided in identical opaque packages and both subjects and researchers will be blinded to the content. After signing informed (-2 week) consent, the following data will be collected: demographics, lifestyle habits including dietary questionnaires, and medical history. At week 0, week 12 and week 24 all the following tests will be performed: Vital Signs: blood pressure, anthropometric measurements, body composition determined by bioelectrical impedance analysis (BIA). Biochemical blood tests: liver function tests fasting glucose insulin & lipid profile, CRP (an inflammation marker), SCFA, BCAA, and LBP and FGF 19. Fecal samples: fecal samples will be used for microbiota composition analysis, and BA analysis. Assessment of liver status At week 0 and 24 by using magnetic resonance spectroscopy (1H-MRS), SteatoTest and NashTest (FibroMax™) and by liver enzymes for evaluating steohepatitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
Keywords
Inulin, OFS (oligofructose)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ITF (Inulin/OFS 75/25)
Arm Type
Experimental
Arm Description
16 gram/day of ITF (Inulin/OFS 75/25)
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
16 gram/day of maltodextrin (placebo)
Intervention Type
Dietary Supplement
Intervention Name(s)
ITF (Inulin/OFS 75/25)
Other Intervention Name(s)
Prebiotics- Inulin, OFS - oligofructose
Intervention Description
Participants will consume 16 g/day ITF
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Other Intervention Name(s)
maltodextrin
Intervention Description
Participants will consume 16 g/day maltodextrin
Primary Outcome Measure Information:
Title
Change from baseline in the severity of NAFLD
Description
Determined by liver fat fraction measured by magnetic resonance spectroscopy (1H-MRS) Blood test for calculate Inflammation score using SteatoTest and NashTest (FibroMax™) Blood test for liver enzyme
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change from baseline of gut microbiota composition.
Description
Quantitative evaluation of the change in the composition of bacteria from stool samples
Time Frame
12 weeks
Title
Change from baseline in glycemic control
Description
Determine by OGTT.
Time Frame
12 weeks
Title
Change from baseline in insulin sensitivity
Description
Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA).
Time Frame
12 weeks
Title
Change from baseline in lipid profile
Description
Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of NAFLD based on fatty infiltration detection by ultrasonography and alanine aminotransferase levels of (ALT) ≥ 30 U/L male ≥ 19 U/L females. Over-weight (BMI ≥ 27 kg/m2) who fulfill the criteria of the National Cholesterol Education Program (NCEP) metabolic syndrome Willing to sign informed consent to participate in the study Patients without diabetes or with well-controlled diabetes (HbA1C < 7.5%) who are treated by diet ± metformin Exclusion Criteria: Pregnancy Uncontrolled diabetes Diabetic treatment other than metformin, unusual diets (vegetarian, vegan), usage of antibiotics, probiotics or prebiotics up to 6 months prior to study, alcohol abuse, presence of gastrointestinal or mental disorders, weight-loss treatment, bariatric surgery Serious medical conditions Evidence of another etiology for chronic liver disease such as: hepatitis B, hepatitis C, HIV, autoimmune diseases and metabolic diseases, medications with known hepatotoxicity.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yaakov Maor, Dr
Organizational Affiliation
Kaplan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kaplan Medical Center
City
Rechovot
ZIP/Postal Code
81207
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23135760
Citation
Dewulf EM, Cani PD, Claus SP, Fuentes S, Puylaert PG, Neyrinck AM, Bindels LB, de Vos WM, Gibson GR, Thissen JP, Delzenne NM. Insight into the prebiotic concept: lessons from an exploratory, double blind intervention study with inulin-type fructans in obese women. Gut. 2013 Aug;62(8):1112-21. doi: 10.1136/gutjnl-2012-303304. Epub 2012 Nov 7.
Results Reference
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Prebiotics in Patients With Non-alcoholic Liver Disease

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