Non-alcoholic Fatty Liver DiseaseNCT02642172
Prebiotics in Patients With Non-alcoholic Liver Disease
A study testing ITF (Inulin/OFS 75/25) in people with Non-alcoholic Fatty Liver Disease and Metabolic Syndrome, run by Kaplan Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
- What is being tested?
- ITF (Inulin/OFS 75/25)
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2016to 20 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read the 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.
- Being tested
- ITF (Inulin/OFS 75/25), Placebo
- Keywords
- Inulin, OFS (oligofructose)
- Medical subject headings
- Non-alcoholic Fatty Liver Disease, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ITF (Inulin/OFS 75/25)Dietary supplement
Also called Prebiotics- Inulin, OFS - oligofructose
Participants will consume 16 g/day ITF
PlaceboDietary supplement
Also called maltodextrin
Participants will consume 16 g/day maltodextrin
| Study group | Role | What they receive |
|---|---|---|
| ITF (Inulin/OFS 75/25) | Experimental | 16 gram/day of ITF (Inulin/OFS 75/25) Receives: Dietary Supplement: ITF (Inulin/OFS 75/25) |
| placebo | Placebo comparator | 16 gram/day of maltodextrin (placebo) Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 12 weeks
Secondary outcomes (4)
Change from baseline of gut microbiota composition.
Quantitative evaluation of the change in the composition of bacteria from stool samples
Measured: 12 weeks
Change from baseline in glycemic control
Determine by OGTT.
Measured: 12 weeks
Change from baseline in insulin sensitivity
Which will be determined by a fasting Glucose and Insulin blood tests and Calculate homeostasis model assessment (HOMA).
Measured: 12 weeks
Change from baseline in lipid profile
Which will be determined by blood test for lipid profile - Triglycerides, cholesterol-LDL and cholesterol-HDL
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2015 (estimated)
- Study startJan 2016
- Primary completion20 Mar 2023
- Study completion20 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yaakov Maor, Kaplan Medical Center
- Investigators
- Yaakov Maor, Dr, Principal investigator, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02642172
- Sponsor's protocol ID
- PN-837-CTIL
- Status last verified
- Nov 2023
- First submitted
- 13 Dec 2015
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 23135760
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02642172
- Acronym / sponsor ID
- PN-837-CTIL
- Keywords
- Inulin, OFS (oligofructose)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 20 Mar 2023 (actual)
- First posted
- 30 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ITF (Inulin/OFS 75/25) | Experimental | Dietary Supplement: ITF (Inulin/OFS 75/25)16 gram/day of ITF (Inulin/OFS 75/25) |
| placebo | Placebo comparator | Dietary Supplement: Placebo16 gram/day of maltodextrin (placebo) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ITF (Inulin/OFS 75/25)Also: Prebiotics- Inulin, OFS - oligofructoseParticipants will consume 16 g/day ITF | Dietary supplement | ITF (Inulin/OFS 75/25) |
| PlaceboAlso: maltodextrinParticipants will consume 16 g/day maltodextrin | Dietary supplement | placebo |
Primary outcome
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
4 secondary outcomes
Change from baseline of gut microbiota composition.
Time frame: 12 weeks
Change from baseline in glycemic control
Time frame: 12 weeks
Change from baseline in insulin sensitivity
Time frame: 12 weeks
Change from baseline in lipid profile
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Background: PubMed 23135760Dewulf 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaakov Maor, Dr principal investigator
Kaplan Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ITF (Inulin/OFS 75/25) in people with Non-alcoholic Fatty Liver Disease and Metabolic Syndrome, run by Kaplan Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in the severity of NAFLD (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02642172, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.