Non-Alcoholic Fatty Liver DiseaseINSYTENCT01680640

Investigation of Synbiotic Treatment in NAFLD

A study testing Synbiotic and Maltodextrin in people with Non-Alcoholic Fatty Liver Disease, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the liver not caused by alcohol. The liver is an organ that is not designed to build up fat. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Non-Alcoholic Fatty Liver Disease
What is being tested?: Synbiotic and Maltodextrin
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 104 participants
Where: 1 siteUnited Kingdom
Study dates: Dec 2013to Jan 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Both men and women
Age > 18 years
Liver fat diagnosed on normal clinical grounds including in most cases liver assessed by Kleiner scoring system to classify severity, with no known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B \& C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis). Last liver biopsy will be within 3 years of recruitment to the study.
Liver fat diagnosed by ultrasound, CT or magnetic resonance imaging (MRI) in patients who also have either diabetes and/or features of the metabolic syndrome, without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B \& C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
Alcohol consumption ≤ 14 units / week for women ≤ 21 units / week for men.

Who cannot join

Alcohol consumption > 15 units /week for women and > 22 units /week for men.
Decompensated acute or chronic liver disease.
A history of viral hepatitis, diarrhoea, diverticulosis, irritable bowel syndrome, inflammatory bowel diseases, coeliac disease (seropositivity for anti-endomysial immunoglobulin A antibodies; immunoglobulin A (IgA) EMA).
Previous bariatric or other abdominal surgery.
Continuous use of antibiotics that may change gut microflora, probiotics, or antisecretory drugs capable of causing achlorhydria within the 2 months preceding enrolment, or evidence of immunoglobulin A or immunoglobulin deficiency (both of which produce confounding effects during assessments of intestinal permeability and small intestinal bacterial overgrowth).

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

Southamption General Hospital
Southampton, Hants, SO166YD

Other trials in United Kingdom

About this study

Official title: Investigation of the Effects of a Synbiotic on Liver Fat, Disease Biomarkers and Intestinal Microbiota in Non-alcoholic Fatty Liver Disease

Non-alcoholic fatty liver disease (NAFLD) is a liver condition in which fat builds up in the liver not caused by alcohol. The liver is an organ that is not designed to build up fat. NAFLD is common in people who have too much body fat in their abdomen or who have diabetes (high blood sugar), but does not always exist with these conditions. NAFLD can also occur in thin people too. NAFLD can be harmful to the liver and may cause the liver to fail over time. NAFLD may also cause adult (or type 2) diabetes and also heart disease. In people who already have diabetes, NAFLD can cause glucose (sugar) levels to be too high.

Our intestines (guts) contain healthy bacteria and some harmful bacteria (bugs). This balance of healthy and harmful bugs is essential for the normal workings of our intestine to digest food. Providing these bacteria do not leak out into the blood they do not cause harm. If the balance of healthy to harmful bugs is upset, the harmful can cause problems and leak out into the blood. Because the liver is connected to the intestine by blood vessels the harmful bacteria can get to the liver and cause problems. These bacteria can cause the liver and the body to build up too much fat and might cause NAFLD and obesity. In this study, we will test the effects of a supplement (synbiotic) taken during the day, that contains a mixture of 'good' healthy bacteria (probiotic) and a sugar (prebiotic) that is not broken down and absorbed into the blood. We will test whether the synbiotic supplement has beneficial effects on the NAFLD liver condition and on factors linked to too much body fat, diabetes and heart disease.

Read the detailed description

We will recruit people with NAFLD who have been diagnosed as part of their NHS (National Health Service) care with having this condition. At present there is no treatment for this condition.

Purpose and design:

We are asking the research question: "Does the modulation of gut microflora with a synbiotic improve non-alcoholic fatty liver disease and the related risk factors for heart disease and type 2 diabetes?"

Presently there is no treatment for this liver condition. Research evidence suggests that a synbiotic supplement might be beneficial for this condition.

To address this research question we want to undertake a randomised double blind placebo controlled trial recruiting people who have been diagnosed with NAFLD.

Conditions: Non-Alcoholic Fatty Liver Disease
Being tested: Synbiotic, Maltodextrin
Keywords: non alcoholic fatty liver disease, NAFLD, synbiotic, gut microbiota, intervention, RCT (Randomized Clinical Trial), biomarkers
Medical subject headings: Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SynbioticDietary supplement
The synbiotic to be used is fructo-oligosacharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day).
MaltodextrinDietary supplement

Study groups in NCT01680640
Study group	Role	What they receive
Synbiotic	Active comparator	Fructo-oligosacharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis (BB-12) as minimum of 10 billion colony forming unit (CFU)/day (1 capsule a day). Receives: Dietary Supplement: Synbiotic
Maltodextrin	Placebo comparator	4 grams of maltodextrin daily. Receives: Dietary Supplement: Maltodextrin

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Liver Fat
Change in liver fat percent was calculated as the percent liver fat at the end of the study, minus the percent of liver fat prior to the intervention. Change in liver fat percent ranged from -60.6% (good) to + 33.7% (bad).
Measured: baseline and 12 months
Change in Enhanced Liver Fibrosis Score (ELF)
Change in Enhanced Liver Fibrosis score (ELF) was calculated as ELF score at the end of the study minus ELF score prior to the intervention (at baseline). A decrease in the ELF score was considered good as it reflected a decrease in liver fibrosis, and an increase in ELF score was considered bad as it reflected an increase in liver fibrosis.
Change in ELF scores ranged from -0.56 (good) to + 0.68 (bad).
Measured: baseline and 12 months
Change in NAFLD Fibrosis Score
Change in NAFLD Fibrosis Score (NFS) was calculated as the NFS score at the end of the study, minus NFS score prior to the intervention (at baseline). A decrease in the NFS score was considered good because it reflected a decrease in liver fibrosis, and an increase in NFS score was considered bad, as it reflected an increase in liver fibrosis.
Change in NFS scores ranged from -2.07 (good) to + 1.75 (bad)
Measured: baseline and 12 months
Change in Bifidobacterium Spp.
The change in percent of Bifidobacteria spp was computed as the percent of Bifidobactera spp at the end of the study minus the percent of Bifidobacteria prior to the intervention (at baseline).
A positive change in percent (e.g +0.1 to 7.0%) in Bifidobacteria spp. was considered good and a negative change in percent (e.g. -0.1 to -0.5%) in Bifidobacteria spp. considered bad. (Minimum = -0.5% (bad) and Maximum = +7.0% (good)).
Measured: baseline and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2013Jan 2019

First posted7 Sep 2012 (estimated)
Study startDec 2013
Primary completionJan 2019
Study completionJan 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)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: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01680640
Sponsor's protocol ID: RHM MED1071
Acronym: INSYTE
Status last verified: Oct 2020
First submitted: 24 Aug 2012
Last updated: 5 Feb 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Scorletti E, Afolabi PR, Miles EA, Smith DE, Almehmadi A, Alshathry A, Childs CE, Del Fabbro S, Bilson J, Moyses HE, Clough GF, Sethi JK, Patel J, Wright M, Breen DJ, Peebles C, Darekar A, Aspinall R, Fowell AJ, Dowman JK, Nobili V, Targher G, Delzenne NM, Bindels LB, Calder PC, Byrne CD. Synbiotics Alter Fecal Microbiomes, But Not Liver Fat or Fibrosis, in a Randomized Trial of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2020 May;158(6):1597-1610.e7. doi: 10.1053/j.gastro.2020.01.031. Epub 2020 Jan 25.
PubMed 31987796
Scorletti E, Afolabi PR, Miles EA, Smith DE, Almehmadi A, Alshathry A, Moyses HE, Clough GF, Wright M, Patel J, Bindels L, Delzenne NM, Calder PC, Byrne CD. Design and rationale of the INSYTE study: A randomised, placebo controlled study to test the efficacy of a synbiotic on liver fat, disease biomarkers and intestinal microbiota in non-alcoholic fatty liver disease. Contemp Clin Trials. 2018 Aug;71:113-123. doi: 10.1016/j.cct.2018.05.010. Epub 2018 May 19.
PubMed 29787859
Byrne CD, Targher G. Time to Replace Assessment of Liver Histology With MR-Based Imaging Tests to Assess Efficacy of Interventions for Nonalcoholic Fatty Liver Disease. Gastroenterology. 2016 Jan;150(1):7-10. doi: 10.1053/j.gastro.2015.11.016. Epub 2015 Nov 18. No abstract available.
PubMed 26602219
Byrne CD, Targher G. Ectopic fat, insulin resistance, and nonalcoholic fatty liver disease: implications for cardiovascular disease. Arterioscler Thromb Vasc Biol. 2014 Jun;34(6):1155-61. doi: 10.1161/ATVBAHA.114.303034. Epub 2014 Apr 17.
PubMed 24743428

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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NAFLD Clinical Care Pathway
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RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
RecruitingPhase 1
A Study of Efimosfermin Alfa in Adults With Hepatic Impairment
Non-alcoholic Fatty Liver Disease
RecruitingPhase 2
A Study of Efimosfermin Alfa in Participants With Biopsy-confirmed Cirrhosis (Compensated) Due to MASH
Metabolic Dysfunction-Associated Steatohepatitis, Non-alcoholic Fatty Liver Disease

All Non-Alcoholic Fatty Liver Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Investigation of the Effects of a Synbiotic on Liver Fat, Disease Biomarkers and Intestinal Microbiota in Non-alcoholic Fatty Liver Disease
ClinicalTrials.gov ID: NCT01680640
Acronym / sponsor ID: INSYTE / RHM MED1071
Conditions: Non-Alcoholic Fatty Liver Disease
Keywords: non alcoholic fatty liver disease, NAFLD, synbiotic, gut microbiota, intervention, RCT (Randomized Clinical Trial), biomarkers
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
Collaborators: National Institute for Health Research, United Kingdom
Study start: Dec 2013
Primary completion: Jan 2019 (actual)
Study completion: Jan 2019 (actual)
First posted: 7 Sep 2012 (estimated)
Results: Posted 5 Feb 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

We will recruit people with NAFLD who have been diagnosed as part of their NHS (National Health Service) care with having this condition. At present there is no treatment for this condition.

Purpose and design:

Presently there is no treatment for this liver condition. Research evidence suggests that a synbiotic supplement might be beneficial for this condition.

To address this research question we want to undertake a randomised double blind placebo controlled trial recruiting people who have been diagnosed with NAFLD.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Synbiotic	Active comparator	Dietary Supplement: SynbioticFructo-oligosacharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis (BB-12) as minimum of 10 billion colony forming unit (CFU)/day (1 capsule a day).
Maltodextrin	Placebo comparator	Dietary Supplement: Maltodextrin4 grams of maltodextrin daily.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Both men and women
Age > 18 years
Liver fat diagnosed on normal clinical grounds including in most cases liver assessed by Kleiner scoring system to classify severity, with no known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B \& C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis). Last liver biopsy will be within 3 years of recruitment to the study.
Liver fat diagnosed by ultrasound, CT or magnetic resonance imaging (MRI) in patients who also have either diabetes and/or features of the metabolic syndrome, without evidence of known aetiological factors for underlying liver disease (e.g. exclusion of hepatitis A, B \& C, primary biliary cirrhosis, autoimmune hepatitis, haemochromatosis).
Alcohol consumption ≤ 14 units / week for women ≤ 21 units / week for men.

Key exclusion criteria (5 listed)

Alcohol consumption > 15 units /week for women and > 22 units /week for men.
Decompensated acute or chronic liver disease.
A history of viral hepatitis, diarrhoea, diverticulosis, irritable bowel syndrome, inflammatory bowel diseases, coeliac disease (seropositivity for anti-endomysial immunoglobulin A antibodies; immunoglobulin A (IgA) EMA).
Previous bariatric or other abdominal surgery.
Continuous use of antibiotics that may change gut microflora, probiotics, or antisecretory drugs capable of causing achlorhydria within the 2 months preceding enrolment, or evidence of immunoglobulin A or immunoglobulin deficiency (both of which produce confounding effects during assessments of intestinal permeability and small intestinal bacterial overgrowth).

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
SynbioticThe synbiotic to be used is fructo-oligosacharide with a degree of polymerization < 10 at 4 g/twice a day (two sticks a day) plus Bifidobacterium animalis subsp. lactis BB-12 as minimum of 10 billion CFU/day (1 capsule a day).	Dietary supplement	Synbiotic
Maltodextrin	Dietary supplement	Maltodextrin

Primary outcome

Change in Liver Fat
Time frame: baseline and 12 months
Change in liver fat percent was calculated as the percent liver fat at the end of the study, minus the percent of liver fat prior to the intervention. Change in liver fat percent ranged from -60.6% (good) to + 33.7% (bad).
Change in Enhanced Liver Fibrosis Score (ELF)
Time frame: baseline and 12 months
Change in Enhanced Liver Fibrosis score (ELF) was calculated as ELF score at the end of the study minus ELF score prior to the intervention (at baseline). A decrease in the ELF score was considered good as it reflected a decrease in liver fibrosis, and an increase in ELF score was considered bad as it reflected an increase in liver fibrosis. Change in ELF scores ranged from -0.56 (good) to + 0.68 (bad).
Change in NAFLD Fibrosis Score
Time frame: baseline and 12 months
Change in NAFLD Fibrosis Score (NFS) was calculated as the NFS score at the end of the study, minus NFS score prior to the intervention (at baseline). A decrease in the NFS score was considered good because it reflected a decrease in liver fibrosis, and an increase in NFS score was considered bad, as it reflected an increase in liver fibrosis. Change in NFS scores ranged from -2.07 (good) to + 1.75 (bad)
Change in Bifidobacterium Spp.
Time frame: baseline and 12 months
The change in percent of Bifidobacteria spp was computed as the percent of Bifidobactera spp at the end of the study minus the percent of Bifidobacteria prior to the intervention (at baseline). A positive change in percent (e.g +0.1 to 7.0%) in Bifidobacteria spp. was considered good and a negative change in percent (e.g. -0.1 to -0.5%) in Bifidobacteria spp. considered bad. (Minimum = -0.5% (bad) and Maximum = +7.0% (good)).

Results and safety

Results posted to the registry on 5 Feb 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Synbiotic	55	45
Maltodextrin	49	44

Primary outcome: Change in Liver Fat

Time frame: baseline and 12 months. Mean (95% Confidence Interval). Unit: percentage of liver fat

Measure	Synbiotic n = 45	Maltodextrin n = 44
Value	-3.8 (-7.98 to 0.38)	-6.0 (-10.6 to -1.45)

Synbiotic vs Maltodextrin: Mean Difference (Net): -3.8, p =0.05, Regression, Linear
Synbiotic vs Maltodextrin: Median Difference (Final Values): -1.7, p <0.001, Regression, Linear

Population analysed: numerical difference between baseline measurement and 12 month measurement

Primary outcome: Change in Enhanced Liver Fibrosis Score (ELF)

Time frame: baseline and 12 months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Synbiotic n = 45	Maltodextrin n = 44
Value	0.12 (0.03 to 0.19)	0.13 (0.05 to 0.19)

Synbiotic vs Maltodextrin: Mean Difference (Final Values): 0.1, p = 1.00, Regression, Linear

Population analysed: numerical difference between baseline measurement and 12 month measurement

Primary outcome: Change in NAFLD Fibrosis Score

Time frame: baseline and 12 months. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Synbiotic n = 45	Maltodextrin n = 44
Value	-1.3 (-1.68 to -0.92)	-1.2 (-1.58 to -0.82)

Synbiotic vs Maltodextrin: Mean Difference (Final Values): 0.2, p = 0.80, Regression, Linear

Population analysed: numerical difference between baseline measurement and 12 month measurement

Primary outcome: Change in Bifidobacterium Spp.

Time frame: baseline and 12 months. Mean (95% Confidence Interval). Unit: percentage of fecal Bifidobacterium spp

Measure	Synbiotic n = 45	Maltodextrin n = 44
Value	1.72 (0.89 to 2.55)	-0.02 (-0.46 to 0.42)

Synbiotic vs Maltodextrin: Median Difference (Final Values): 0.97, p <0.001, Beta-diversity indexes

Population analysed: numerical difference between baseline measurement and 12 month measurement

Adverse events

Time frame: The adverse event data were collected over the period of the study between baseline and end of study (total period 12 months).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Synbiotic	6 of 55 (10.9%)	35 of 55 (63.6%)	0 of 55
Maltodextrin	6 of 49 (12.2%)	30 of 49 (61.2%)	0 of 49

Limitations and caveats (from the sponsor): We choose one strain of bacteria in the synbiotic. The study was designed as a phase-2 clinical trial using magnetic resonance spectroscopy (MRS) and not liver biopsy. We deliberately did not include a lifestyle intervention as we wanted to test the effect of the synbiotic alone.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31987796Scorletti E, Afolabi PR, Miles EA, Smith DE, Almehmadi A, Alshathry A, Childs CE, Del Fabbro S, Bilson J, Moyses HE, Clough GF, Sethi JK, Patel J, Wright M, Breen DJ, Peebles C, Darekar A, Aspinall R, Fowell AJ, Dowman JK, Nobili V, Targher G, Delzenne NM, Bindels LB, Calder PC, Byrne CD. Synbiotics Alter Fecal Microbiomes, But Not Liver Fat or Fibrosis, in a Randomized Trial of Patients With Nonalcoholic Fatty Liver Disease. Gastroenterology. 2020 May;158(6):1597-1610.e7. doi: 10.1053/j.gastro.2020.01.031. Epub 2020 Jan 25.
Derived from this study: PubMed 29787859Scorletti E, Afolabi PR, Miles EA, Smith DE, Almehmadi A, Alshathry A, Moyses HE, Clough GF, Wright M, Patel J, Bindels L, Delzenne NM, Calder PC, Byrne CD. Design and rationale of the INSYTE study: A randomised, placebo controlled study to test the efficacy of a synbiotic on liver fat, disease biomarkers and intestinal microbiota in non-alcoholic fatty liver disease. Contemp Clin Trials. 2018 Aug;71:113-123. doi: 10.1016/j.cct.2018.05.010. Epub 2018 May 19.
Derived from this study: PubMed 26602219Byrne CD, Targher G. Time to Replace Assessment of Liver Histology With MR-Based Imaging Tests to Assess Efficacy of Interventions for Nonalcoholic Fatty Liver Disease. Gastroenterology. 2016 Jan;150(1):7-10. doi: 10.1053/j.gastro.2015.11.016. Epub 2015 Nov 18. No abstract available.
Derived from this study: PubMed 24743428Byrne CD, Targher G. Ectopic fat, insulin resistance, and nonalcoholic fatty liver disease: implications for cardiovascular disease. Arterioscler Thromb Vasc Biol. 2014 Jun;34(6):1155-61. doi: 10.1161/ATVBAHA.114.303034. Epub 2014 Apr 17.

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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.

Christopher D Byrne, MBBCh, PhD principal investigator

University of Southampton/University Hospital Southampton NHS Foundation Trust

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Synbiotic and Maltodextrin in people with Non-Alcoholic Fatty Liver Disease, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.

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 5 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 5 Feb 2021. 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 United Kingdom. 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?

Yes. Results are posted in the registry (first posted 5 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 in Liver Fat (time frame: baseline and 12 months). The study lists 4 primary outcomes in all. 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 NCT01680640, which also lists 4 linked publications.

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 5 Feb 2021.