Prebiotics in Patients With Non-alcoholic Liver Disease

Metabolic Syndrome Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02642172
• Other study ID #: PN-837-CTIL
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: March 20, 2023

Study information

• Verified date: November 2023
• Source: Kaplan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: March 20, 2023
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fatty Liver
• Liver Diseases
• Metabolic Syndrome
• Non-alcoholic Fatty Liver Disease

Intervention

Dietary Supplement:
• ITF (Inulin/OFS 75/25)
Participants will consume 16 g/day ITF
• Placebo
Participants will consume 16 g/day maltodextrin

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rechovot

Sponsors (1)

Lead Sponsor	Collaborator
Kaplan Medical Center

Country where clinical trial is conducted

Israel, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 weeks
Secondary	Change from baseline of gut microbiota composition.	Quantitative evaluation of the change in the composition of bacteria from stool samples	12 weeks
Secondary	Change from baseline in glycemic control	Determine by OGTT.	12 weeks
Secondary	Change from baseline in insulin sensitivity	Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA).	12 weeks
Secondary	Change from baseline in lipid profile	Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL	12 weeks