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Trial record 21 of 98 for:    grams | maltodextrin

Prebiotics in Patients With Non-alcoholic Liver Disease

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ClinicalTrials.gov Identifier: NCT02642172
Recruitment Status : Recruiting
First Posted : December 30, 2015
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yaakov Maor, Kaplan Medical Center

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.

Condition or disease Intervention/treatment Phase
Non-alcoholic Fatty Liver Disease Metabolic Syndrome Dietary Supplement: ITF (Inulin/OFS 75/25) Dietary Supplement: Placebo Not Applicable

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 20 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. Stage 3- Extension period: All patients will receive 16 gram/day of ITF for 8 weeks.

After signing informed consent, the following data will be collected: demographics, lifestyle habits including dietary questionnaires, and medical history. At the end of week 2, week 12 and week 20 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, 75 gram oral glucose tolerance test (OGTT), 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 2, 12, and 20 by using magnetic resonance spectroscopy (1H-MRS), SteatoTest and NashTest (FibroMax™) and by liver enzymes for evaluating steohepatitis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 2016
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases
Drug Information available for: Inulin

Arm Intervention/treatment
Experimental: ITF (Inulin/OFS 75/25)
16 gram/day of ITF (Inulin/OFS 75/25)
Dietary Supplement: ITF (Inulin/OFS 75/25)
Participants will consume 16 g/day ITF
Other Name: Prebiotics- Inulin, OFS - oligofructose

Placebo Comparator: placebo
16 gram/day of maltodextrin (placebo)
Dietary Supplement: Placebo
Participants will consume 16 g/day maltodextrin
Other Name: maltodextrin




Primary Outcome Measures :
  1. Change from baseline in the severity of NAFLD [ Time Frame: 12 weeks ]

    Determined by

    1. liver fat fraction measured by magnetic resonance spectroscopy (1H-MRS)
    2. Blood test for calculate Inflammation score using SteatoTest and NashTest (FibroMax™)
    3. Blood test for liver enzyme


Secondary Outcome Measures :
  1. Change from baseline of gut microbiota composition. [ Time Frame: 12 weeks ]
    Quantitative evaluation of the change in the composition of bacteria from stool samples

  2. Change from baseline in glycemic control [ Time Frame: 12 weeks ]
    Determine by OGTT.

  3. Change from baseline in insulin sensitivity [ Time Frame: 12 weeks ]
    Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA).

  4. Change from baseline in lipid profile [ Time Frame: 12 weeks ]
    Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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 ClinicalTrials.gov identifier (NCT number): NCT02642172


Contacts
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Contact: Yaakov Maor, Dr 972-542060260 yaakovma1@clalit.org.il
Contact: Naama Reshef, M.sc Nutr 972506705552 reshefn2@gmail.com

Locations
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Israel
Kaplan Medical Center Recruiting
Rechovot, Israel, 81207
Contact: Naama reshef    +972506705552    reshefn2@gmail.com   
Sponsors and Collaborators
Kaplan Medical Center
Investigators
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Principal Investigator: Yaakov Maor, Dr Kaplan Medical Center

Publications:
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Responsible Party: Yaakov Maor, Principal Investigator, Kaplan Medical Center
ClinicalTrials.gov Identifier: NCT02642172     History of Changes
Other Study ID Numbers: PN-837-CTIL
First Posted: December 30, 2015    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Yaakov Maor, Kaplan Medical Center:
Inulin, OFS (oligofructose)
Additional relevant MeSH terms:
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Liver Diseases
Fatty Liver
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Digestive System Diseases