Non-Alcoholic Fatty Liver DiseaseNCT02568787
The Effect of an RBAC Supplement (BRM4) on NAFLD
A study testing rice bran arabinoxylan compound (RBAC) in people with Non-Alcoholic Fatty Liver Disease, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This nutritional supplement is made from a water soluble extract of rice bran that has been partially hydrolyzed by the action of a natural… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-Alcoholic Fatty Liver Disease
- What is being tested?
- rice bran arabinoxylan compound (RBAC)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 10 Jun 2017
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Confirmed NAFLD diagnosis
- On a stable medication regimen during the intervention
- Planning to maintain current medication during the course of the intervention
- Willing to have blood drawn
- Previous nutritional supplement usage of similar polysaccharide formula permitted, but current use must be stopped 2 weeks before and during trial
Show all 10Show fewer
- Interested in participating in a dietary supplement study
- Willing to follow recommendations for participating in the study
- Willing to not consume food, alcohol, caffeine, or stimulants (amphetamines) 12 hours before each assessment
- Able to provide informed consent
Who cannot join
- Currently enrolled in another research trial for similar investigative nutritional therapies
- Known allergy to rice, rice bran, mushrooms, or related food products
- Any gastrointestinal disorders that could lead to uncertain absorption of the study supplement
- Taking any lipid-lowering agent for the prior 3 months before study enrollment
- Currently taking immunomodulatory medication, i.e., interferon
- Currently taking chemotherapeutic agents
Show all 16Show fewer
- Severe anemia or other medical condition that will not permit a safe blood draw
- A bleeding disorder
- A terminal illness
- Women who are pregnant or are attempting conception, especially in the presence of a history of recurrent spontaneous abortion
- Currently undergoing internal defibrillation, like with an implantable heart device
- Erratic, accelerated, or mechanically controlled irregular heart rhythms
- Atrial fibrillation/flutter
- Atrioventricular block
- Recently had dyes introduced into the bloodstream, such as methylene blue, indocyanine green, indigo carmine, and fluorescein
- Any implanted electronic device
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Miami Miller School of Medicine, Soffer Clinical Research Center, Department of Psychiatry & Behavioral Sciences
Miami, Florida, 33136-2107
About this study
Official title: The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This nutritional supplement is made from a water soluble extract of rice bran that has been partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom.
Read the detailed description
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This nutritional supplement is made from a water soluble extract of rice bran that has been partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom. Given that these micronutrients may be important for regulating the immune system, investigators will investigate the impact of RBAC on the following variables among 20 adults (18+ years of age and over) diagnosed with NAFLD:
- albumin
- 4-hydroxynonenal
- lipids
- liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP)
- malondialdehyde
- γ-glutamyltransferase
- cytokines (TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF-RI, TNF-RII, IFN-γ, IL-12, IL-2, IL-15, IL-8, IL-4, IL-5, IL-17, IL-23, IL-10, IL-13, and IL-18)
- lymphocytes
- platelets
Specifically, subjects will participate in a 3-month, two-group, randomized intervention, where one group (n=10) will take 1 gram/day RBAC and the other group (n=10) will take a placebo to compare differences in outcomes between the two groups. The results of the study are intended to address the multi-faceted physiological problems of NAFLD patients by testing the efficacy of a nutritional supplement intervention on multiple outcomes in this population.
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Being tested
- rice bran arabinoxylan compound (RBAC), Placebo
- Keywords
- NAFLD, cytokines, interleukin (IL), interferon (IFN), liver function test (LFTS), nutrition, bran arabinoxylan compound (RBAC), tumor necrosis factor -- type I receptor (TNF-RI), TNF-RII (tumor necrosis factor -- type II receptor (TNF-RII)
- 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.
rice bran arabinoxylan compound (RBAC)Dietary supplement
Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
PlaceboDietary supplement
Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period.
| Study group | Role | What they receive |
|---|---|---|
| Rice bran arabinoxylan compound (RBAC) | Experimental | Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period. Receives: Dietary Supplement: rice bran arabinoxylan compound (RBAC) |
| Placebo | Placebo comparator | Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period. 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 liver function test
Liver function tests as defined by serum ALT, AST and ALP
Measured: Baseline, 45 days and 90 days
Change from baseline in metabolic markers
Metabolic markers as defined by lipid profile
Measured: Baseline,45 days and 90 days
Change from baseline in immunological markers
Immunological markers as defined by TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF RI, IFN-γ, IL-12, IL-2, IL-15, IL-8, TNF RII, IL-4, IL-5, IL-17, IL-23, IL-10, IL-13, and IL-18.
Measured: Baseline,45 days and, 3 months
Secondary outcomes (4)
Change from baseline in systolic blood pressure
Systolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis.
Measured: Baseline,45 days and 3 months
Change from baseline in Diastolic blood pressure
Diastolic blood pressure will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis.
Measured: 45 days and 90 days
Pulse
Pulse will be measured to the nearest even digit by use of the Microlife Deluxe upper arm blood pressure monitor. Three readings will be made with the subjects seated after they have rested for five minutes. The average of the three readings will be used in the analysis.
Measured: Baseline,45 days and 3 months
Change from Baseline in Quality of Life
The SF-36v2™ Health Survey (15) provides psychometrically-based physical and mental health summary measures and a preference-based health utility index. It is a generic measure that does not target a specific age, disease, or treatment group.
Measured: Baseline,45 days and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2015 (estimated)
- Study startMay 2016
- Primary completion10 Jun 2017
- Study completion10 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Non-Alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Daiwa Health Development
- Responsible party
- Principal investigator, John E. Lewis, University of Miami
- Investigators
- John E Lewis, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02568787
- Sponsor's protocol ID
- 20150512
- Status last verified
- Jun 2017
- First submitted
- 1 Oct 2015
- Last updated
- 14 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Parnell JA, Raman M, Rioux KP, Reimer RA. The potential role of prebiotic fibre for treatment and management of non-alcoholic fatty liver disease and associated obesity and insulin resistance. Liver Int. 2012 May;32(5):701-11. doi: 10.1111/j.1478-3231.2011.02730.x. Epub 2011 Dec 30.
PubMed 22221818Byrne CD, Olufadi R, Bruce KD, Cagampang FR, Ahmed MH. Metabolic disturbances in non-alcoholic fatty liver disease. Clin Sci (Lond). 2009 Apr;116(7):539-64. doi: 10.1042/CS20080253.
PubMed 19243311Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.
PubMed 15565570Preiss D, Sattar N. Non-alcoholic fatty liver disease: an overview of prevalence, diagnosis, pathogenesis and treatment considerations. Clin Sci (Lond). 2008 Sep;115(5):141-50. doi: 10.1042/CS20070402.
PubMed 18662168Neuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. doi: 10.1053/jhep.2003.50193.
PubMed 12717402Dowman JK, Armstrong MJ, Tomlinson JW, Newsome PN. Current therapeutic strategies in non-alcoholic fatty liver disease. Diabetes Obes Metab. 2011 Aug;13(8):692-702. doi: 10.1111/j.1463-1326.2011.01403.x.
PubMed 21449949Patel AA, Torres DM, Harrison SA. Effect of weight loss on nonalcoholic fatty liver disease. J Clin Gastroenterol. 2009 Nov-Dec;43(10):970-4. doi: 10.1097/MCG.0b013e3181b57475.
PubMed 19727004Musso G, Gambino R, Cassader M, Pagano G. A meta-analysis of randomized trials for the treatment of nonalcoholic fatty liver disease. Hepatology. 2010 Jul;52(1):79-104. doi: 10.1002/hep.23623.
PubMed 20578268Zheng S, Sanada H, Dohi H, Hirai S, Egashira Y. Suppressive effect of modified arabinoxylan from rice bran (MGN-3) on D-galactosamine-induced IL-18 expression and hepatitis in rats. Biosci Biotechnol Biochem. 2012;76(5):942-6. doi: 10.1271/bbb.110968. Epub 2012 May 7.
PubMed 22738964Zheng S, Sugita S, Hirai S, Egashira Y. Protective effect of low molecular fraction of MGN-3, a modified arabinoxylan from rice bran, on acute liver injury by inhibition of NF-kappaB and JNK/MAPK expression. Int Immunopharmacol. 2012 Dec;14(4):764-9. doi: 10.1016/j.intimp.2012.10.012. Epub 2012 Oct 29.
PubMed 23116638Ghoneum M. Enhancement of human natural killer cell activity by modified Arabinoxylan from rice bran (MGN-3). Int J Immunotherapy 1998;14(2):89-99.
Ghoneum M, Matsuura M. Augmentation of macrophage phagocytosis by modified arabinoxylan rice bran (MGN-3/biobran). Int J Immunopathol Pharmacol. 2004 Sep-Dec;17(3):283-92. doi: 10.1177/039463200401700308.
PubMed 15461862Tazawa K, Namikawa H, Oida N, Masada M, Maeda H. Scavenging activity of modified arabinoxylane from rice bran (biobran/mgn-3) with natural killer cell activity on free radicals. Biotherapy 2000;14:493-5.
Ali K, Melillo A, Leonard S, Asthana D, Woolger J, Wolfson A, et al. An open-label, randomized clinical trial to assess the immunomodulatory activity of a novel oligosaccharide compound in healthy adults. Functional Foods in Health and Disease 2012;2(7):265-79.
Ware J, Kosinski M, Dewey J. How to score version two of the SF-36 health survey. Lincoln, RI: QualityMetric, Incorporated; 2000. ISBN 1891810057
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of an Enhanced Rice Bran Nutritional Supplement on Non-Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02568787
- Acronym / sponsor ID
- 20150512
- Conditions
- Non-Alcoholic Fatty Liver Disease
- Keywords
- NAFLD, cytokines, interleukin (IL), interferon (IFN), liver function test (LFTS), nutrition, bran arabinoxylan compound (RBAC), tumor necrosis factor -- type I receptor (TNF-RI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Daiwa Health Development
- Study start
- May 2016 (actual)
- Primary completion
- 10 Jun 2017 (actual)
- Study completion
- 10 Jun 2017 (actual)
- First posted
- 6 Oct 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 study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This nutritional supplement is made from a water soluble extract of rice bran that has been partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom.
Detailed description
The purpose of this study is to investigate the effects of Rice Bran Arabinoxylan Compound (RBAC) on outcome variables in persons with non-alcoholic fatty liver disease (NAFLD). This nutritional supplement is made from a water soluble extract of rice bran that has been partially hydrolyzed by the action of a natural enzyme complex extracted from Shiitake mushroom. Given that these micronutrients may be important for regulating the immune system, investigators will investigate the impact of RBAC on the following variables among 20 adults (18+ years of age and over) diagnosed with NAFLD:
- albumin
- 4-hydroxynonenal
- lipids
- liver enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase (ALP)
- malondialdehyde
- γ-glutamyltransferase
- cytokines (TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF-RI, TNF-RII, IFN-γ, IL-12, IL-2, IL-15, IL-8, IL-4, IL-5, IL-17, IL-23, IL-10, IL-13, and IL-18)
- lymphocytes
- platelets
Specifically, subjects will participate in a 3-month, two-group, randomized intervention, where one group (n=10) will take 1 gram/day RBAC and the other group (n=10) will take a placebo to compare differences in outcomes between the two groups. The results of the study are intended to address the multi-faceted physiological problems of NAFLD patients by testing the efficacy of a nutritional supplement intervention on multiple outcomes in this population.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rice bran arabinoxylan compound (RBAC) | Experimental | Dietary Supplement: rice bran arabinoxylan compound (RBAC)Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboTake 2 tablets 1 time (1 gram) per day for the 3-month intervention period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18 or older
- Confirmed NAFLD diagnosis
- On a stable medication regimen during the intervention
- Planning to maintain current medication during the course of the intervention
- Willing to have blood drawn
Key exclusion criteria (16 listed)
- Currently enrolled in another research trial for similar investigative nutritional therapies
- Known allergy to rice, rice bran, mushrooms, or related food products
- Any gastrointestinal disorders that could lead to uncertain absorption of the study supplement
- Taking any lipid-lowering agent for the prior 3 months before study enrollment
- Currently taking immunomodulatory medication, i.e., interferon
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 |
|---|---|---|
| rice bran arabinoxylan compound (RBAC)Take 2 tablets 1 time (1 gram) per day for the 3-month intervention period. | Dietary supplement | Rice bran arabinoxylan compound (RBAC) |
| PlaceboTake 2 tablets 1 time (1 gram) per day for the 3-month intervention period. | Dietary supplement | Placebo |
Primary outcome
Change from baseline in liver function test
Time frame: Baseline, 45 days and 90 days
Liver function tests as defined by serum ALT, AST and ALP
Change from baseline in metabolic markers
Time frame: Baseline,45 days and 90 days
Metabolic markers as defined by lipid profile
Change from baseline in immunological markers
Time frame: Baseline,45 days and, 3 months
Immunological markers as defined by TNF-α, LT-α, IL-1α, IL-1β, IL-6, TNF RI, IFN-γ, IL-12, IL-2, IL-15, IL-8, TNF RII, IL-4, IL-5, IL-17, IL-23, IL-10, IL-13, and IL-18.
4 secondary outcomes
Change from baseline in systolic blood pressure
Time frame: Baseline,45 days and 3 months
Change from baseline in Diastolic blood pressure
Time frame: 45 days and 90 days
Pulse
Time frame: Baseline,45 days and 3 months
Change from Baseline in Quality of Life
Time frame: Baseline,45 days and 3 months
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 14 Jun 2017.
- Background: PubMed 22221818Parnell JA, Raman M, Rioux KP, Reimer RA. The potential role of prebiotic fibre for treatment and management of non-alcoholic fatty liver disease and associated obesity and insulin resistance. Liver Int. 2012 May;32(5):701-11. doi: 10.1111/j.1478-3231.2011.02730.x. Epub 2011 Dec 30.
- Background: PubMed 19243311Byrne CD, Olufadi R, Bruce KD, Cagampang FR, Ahmed MH. Metabolic disturbances in non-alcoholic fatty liver disease. Clin Sci (Lond). 2009 Apr;116(7):539-64. doi: 10.1042/CS20080253.
- Background: PubMed 15565570Browning JD, Szczepaniak LS, Dobbins R, Nuremberg P, Horton JD, Cohen JC, Grundy SM, Hobbs HH. Prevalence of hepatic steatosis in an urban population in the United States: impact of ethnicity. Hepatology. 2004 Dec;40(6):1387-95. doi: 10.1002/hep.20466.
- Background: PubMed 18662168Preiss D, Sattar N. Non-alcoholic fatty liver disease: an overview of prevalence, diagnosis, pathogenesis and treatment considerations. Clin Sci (Lond). 2008 Sep;115(5):141-50. doi: 10.1042/CS20070402.
- Background: PubMed 12717402Neuschwander-Tetri BA, Caldwell SH. Nonalcoholic steatohepatitis: summary of an AASLD Single Topic Conference. Hepatology. 2003 May;37(5):1202-19. doi: 10.1053/jhep.2003.50193.
- Background: PubMed 21449949Dowman JK, Armstrong MJ, Tomlinson JW, Newsome PN. Current therapeutic strategies in non-alcoholic fatty liver disease. Diabetes Obes Metab. 2011 Aug;13(8):692-702. doi: 10.1111/j.1463-1326.2011.01403.x.
- Background: PubMed 19727004Patel AA, Torres DM, Harrison SA. Effect of weight loss on nonalcoholic fatty liver disease. J Clin Gastroenterol. 2009 Nov-Dec;43(10):970-4. doi: 10.1097/MCG.0b013e3181b57475.
- Background: PubMed 20578268Musso G, Gambino R, Cassader M, Pagano G. A meta-analysis of randomized trials for the treatment of nonalcoholic fatty liver disease. Hepatology. 2010 Jul;52(1):79-104. doi: 10.1002/hep.23623.
- Background: PubMed 22738964Zheng S, Sanada H, Dohi H, Hirai S, Egashira Y. Suppressive effect of modified arabinoxylan from rice bran (MGN-3) on D-galactosamine-induced IL-18 expression and hepatitis in rats. Biosci Biotechnol Biochem. 2012;76(5):942-6. doi: 10.1271/bbb.110968. Epub 2012 May 7.
- Background: PubMed 23116638Zheng S, Sugita S, Hirai S, Egashira Y. Protective effect of low molecular fraction of MGN-3, a modified arabinoxylan from rice bran, on acute liver injury by inhibition of NF-kappaB and JNK/MAPK expression. Int Immunopharmacol. 2012 Dec;14(4):764-9. doi: 10.1016/j.intimp.2012.10.012. Epub 2012 Oct 29.
- BackgroundGhoneum M. Enhancement of human natural killer cell activity by modified Arabinoxylan from rice bran (MGN-3). Int J Immunotherapy 1998;14(2):89-99.
- Background: PubMed 15461862Ghoneum M, Matsuura M. Augmentation of macrophage phagocytosis by modified arabinoxylan rice bran (MGN-3/biobran). Int J Immunopathol Pharmacol. 2004 Sep-Dec;17(3):283-92. doi: 10.1177/039463200401700308.
- 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.
John E Lewis, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rice bran arabinoxylan compound (RBAC) in people with Non-Alcoholic Fatty Liver Disease, run by University of Miami at 1 site in United States.
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 10 inclusion and 16 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 14 Jun 2017. 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 States. 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 liver function test (time frame: Baseline, 45 days and 90 days). The study lists 3 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 NCT02568787, which also lists 15 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 14 Jun 2017.