NCT02642172

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 13, 2015

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 30, 2015

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 20, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2023

Completed
Last Updated

November 29, 2023

Status Verified

November 1, 2023

Enrollment Period

7.2 years

First QC Date

December 13, 2015

Last Update Submit

November 25, 2023

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Keywords

Inulin, OFS (oligofructose)

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the severity of NAFLD

    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

    12 weeks

Secondary Outcomes (4)

  • Change from baseline of gut microbiota composition.

    12 weeks

  • Change from baseline in glycemic control

    12 weeks

  • Change from baseline in insulin sensitivity

    12 weeks

  • Change from baseline in lipid profile

    12 weeks

Study Arms (2)

ITF (Inulin/OFS 75/25)

EXPERIMENTAL

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

Dietary Supplement: ITF (Inulin/OFS 75/25)

placebo

PLACEBO COMPARATOR

16 gram/day of maltodextrin (placebo)

Dietary Supplement: Placebo

Interventions

ITF (Inulin/OFS 75/25)DIETARY_SUPPLEMENT

Participants will consume 16 g/day ITF

Also known as: Prebiotics- Inulin, OFS - oligofructose
ITF (Inulin/OFS 75/25)
PlaceboDIETARY_SUPPLEMENT

Participants will consume 16 g/day maltodextrin

Also known as: maltodextrin
placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaplan Medical Center

Rehovot, 81207, Israel

Location

Related Publications (1)

  • 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.

    PMID: 23135760BACKGROUND

MeSH Terms

Conditions

Non-alcoholic Fatty Liver DiseaseMetabolic Syndrome

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Fatty LiverLiver DiseasesDigestive System DiseasesInsulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Yaakov Maor, Dr

    Kaplan Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2015

First Posted

December 30, 2015

Study Start

January 1, 2016

Primary Completion

March 20, 2023

Study Completion

March 20, 2023

Last Updated

November 29, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)