Non-alcoholic Fatty Liver DiseaseNUTRAFASTNCT02369536
Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
A study testing nutraceutical mixture in people with Non-alcoholic Fatty Liver Disease, run by Neuromed IRCCS at 1 site in Italy.
Trial summary
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- nutraceutical mixture
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteItaly
- Study dates
- 18 Aug 2015to 15 Sep 2016
- 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 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- subjects with non alcoholic fatty liver disease (NAFLD)
- presenting ultrasonographic abnormalities of steatosic liver (hyperechogenic parenchyma)
- with plasma levels greater than normal (ranges of each recruiting center) for at least one of the following parameters (aspartate aminotransferase AST, alanine aminotransferase ALT, γ -glutamyltranspeptidase γ-GT).
Who cannot join
- history of alcohol abuse
- use of drugs associated with the development of hepatic steatosis
- malnutrition
- alcoholic chronic liver disease
- chronic liver disease of different etiology (autoimmune disease, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson's disease, deficits of alpha-1 antitrypsin, celiac disease)
- severe renal, cardiac or respiratory insufficiency
Show all 9Show fewer
- malignant tumors
- intolerance to any component of the active ingredients of the formulation
- women who are pregnant or have planned the pregnancy within three months and women who are breast-feeding.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD.
Study design: double-blind, randomized, multicentre trial, placebo-controlled on two parallel groups.
Read more
The study participants are healthy volunteers, since they do not have nor had any liver-related clinical symptom, but simply laboratory (plasma levels greater than normal for at least one of the liver parameters -aspartate aminotransferase AST, alanine aminotransferase ALT or γ -glutamyltranspeptidase γ-GT) or instrumental (ultrasonographic abnormalities of steatosic liver) tests altered as compared to normal ranges.
Three months treatment with the nutraceutical mixture or placebo. Outcomes tested before and at the end of treatment - 3 months).
Read the detailed description
A correct hepatic function is highly relevant from the epidemiological point of view. In Italy, Non Alcoholic Fatty Liver Disease - NAFLD - has a prevalence of 20-25% in the adult population, with peaks of 50-70% within obese and type-2 diabetes populations: it is the most frequent cause of hematic changes in cytonecrosis enzymes, and can explain about 90% of asymptomatic high levels of transaminases. NAFLD natural history is associated with an increase of cerebro and cardiovascular risk, in both healthy subjects and diabetic patients.
Its prevention and treatment are of great interest, in particular dietary and nutraceutical interventions are the object of innovative research. It is also known that about 65% of subjects with hepatic dysfunction consume plant extracts, like silymarin from Cardo marianum. A recent trial showed an improvement of the hepatic function in subjects with NAFLD treated with silybin, combined with phosphatidylcholine and vitamin E. These findings provide valuable information on new therapeutic strategies, but warrant further investigation. For no natural substance a health claim related to liver function was in fact approved by the European Food Safety Authority (EFSA). The only exception is constituted by the food sources of choline, for which the maintenance of normal hepatic function has been claimed.
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD.
Treatment: subjects will be randomized to receive the nutraceutical formulation or placebo for three months, in the amount of two capsules (about 800 mg each) a day, at one time.
All subjects, after signing a written informed consent to participation in the study, will receive appropriate recomendations about diet and physical exercise.
A clinic visit, with collection of the patient clinical and pharmacological history and recording of any adverse event, liver ultrasound, measurement of weight and height and calculation of BMI, measure of arterial blood pressure, collection of a sample of venous blood, under fasting conditions, for hematochemical tests, will be made at the baseline (T0); all examinations and tests (except liver ultrasound) will be repeated after three months of treatment (T1).
Primary end-points of the study: hematic levels of hepatic enzymes: ALT, AST and γ-GT.
Secondary end-points of the study:
- Hepatic function: direct and indirect bilirubin;
- Inflammation markers: C Reactive Protein (CRP), interleukin (IL)-6, IL-1β, IL-8, IL-10, Receptor for Advanced Glycation End Products (RAGE), Advanced Glycation End Products (AGE), insulin-like growth factor-1 (IGF-1)
- Haemostatic function: Factor VII, fibrinogen, thrombin generation with and without thrombomodulin, antithrombin (AT), tissue-type Plasminogen Activator (t-PA), Plasminogen Activator Inhibitor-1(PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI) and activated TAFI (TAFIa), plasmin-antiplasmin complex, plasma fibrinolytic capacity;
- Metabolic syndrome parameters: glycemia, triglycerides, HDL cholesterol, insulin e insulin-resistance (HOMA-IR homeostasis model assessment-estimated insulin resistance), adiponectin;
- Apoptosis parameters: total cytokeratin-18 (M65 antigene), M30 and M65/M65ED, soluble fas and soluble fas ligand.
A weekly food diary will be administered to each subject before and at the end of the treatment, to highlight any possible change of dietary habits during the study.
In addition, for all subjects the NAFLD Fibrosis Score (NFS), a composite score of prognostic value for the conversion of NAFDL into fibrotic hepatitis and for the disease severity, will be calculated. This score includes age, body mass index, platelet count, albumin, relationship between AST and ALT, and presence of diabetes. A sub-analysis will be done to evaluate the efficacy of the treatment with the synergistic blend of ingredients in subjects with high, as compared to those with low NFS.
Sample size calculation: Establishing Alpha = 0.05 and Β = 80%, the number of 150 people (75 per treatment arm) will evaluate differences between the two groups (T1 to T0) equal to 46% of the standard deviation of the mean of the two liver function parameters selected (primary end-points), in particular, differences over 11.5 for ALT (17% of the average), 7.1 for AST (17% of the average) or 13.8 for γ-GT (19% of the average). This calculation also includes a drop-out of 10% of the sample enrolled in the study.
Compliance to treatment will be monitored by counting the capsules returned in the box at the end of treatment.
- Conditions
- Non-alcoholic Fatty Liver Disease
- Being tested
- nutraceutical mixture, placebo
- Keywords
- NAFLD, nutraceutical mixture
- 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.
nutraceutical mixtureDietary supplement
Lifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man)
placeboDietary supplement
Lifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture
| Study group | Role | What they receive |
|---|---|---|
| nutraceutical mixture | Active comparator | Lifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day) Receives: Dietary Supplement: nutraceutical mixture |
| placebo | Placebo comparator | Lifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day) Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematic Levels of Hepatic Enzymes AST
hematic levels of hepatic enzyme: aspartate aminotransferase (AST)
Measured: before and at the end of treatment (three months)
Hematic Levels of Hepatic Enzymes ALT
hematic levels of hepatic enzyme: alanine aminotransferase (ALT)
Measured: before and at the end of treatment (three months)
Hematic Levels of Hepatic Enzymes GGT
hematic levels of hepatic enzyme: gamma-glutamyl transpeptidase (GGT)
Measured: before and at the end of treatment (three months)
Secondary outcomes (5)
Plasma Levels of Hepatic Enzymes
hematic levels of direct bilirubin
Measured: before and at the end of treatment (three months)
Levels of Circulating Inflammation Marker
Levels of circulating Inflammation marker: C Reactive Protein (CRP)
Measured: before and at the end of treatment (three months)
Measures of the Haemostatic Function
Tissue-type Plasminogen Activator (t-PA) levels in plasma
Measured: before and at the end of treatment (three months)
Measures of the Haemostatic Function
Plasminogen Activator Inihibitor (PAI-1) levels in plasma
Measured: before and at the end of treatment (three months)
Measures of the Haemostatic Function
Thrombin activatable fibrinolysis inhibitor (TAFI) levels in plasma
Measured: before and at the end of treatment (three months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2015 (estimated)
- Study start18 Aug 2015
- Primary completion15 Sep 2016
- Study completion15 Sep 2016
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 (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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuromed IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giovanni de Gaetano, Neuromed IRCCS
- Investigators
- Giovanni de Gaetano, MD PhD, Principal investigator, IRCCS Neuromed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02369536
- Sponsor's protocol ID
- Neuromed-Nutrafast-PON2015
- Acronym
- NUTRAFAST
- Status last verified
- Jan 2022
- First submitted
- 17 Feb 2015
- Last updated
- 12 Jan 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ; American Association for the Study of Liver Diseases; American College of Gastroenterology; American Gastroenterological Association. The diagnosis and management of non-alcoholic fatty liver disease: Practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Am J Gastroenterol. 2012 Jun;107(6):811-26. doi: 10.1038/ajg.2012.128. No abstract available.
PubMed 22641309
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Trial on the Efficacy of a Natural Components Mixture in the Treatment of Non Alcoholic Fatty Liver Disease (NAFLD)
- ClinicalTrials.gov ID
- NCT02369536
- Acronym / sponsor ID
- NUTRAFAST / Neuromed-Nutrafast-PON2015
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- NAFLD, nutraceutical mixture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Neuromed IRCCSUniversity, hospital or other
- Study start
- 18 Aug 2015 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 15 Sep 2016 (actual)
- First posted
- 24 Feb 2015 (estimated)
- Results
- Posted 15 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD.
Study design: double-blind, randomized, multicentre trial, placebo-controlled on two parallel groups.
The study participants are healthy volunteers, since they do not have nor had any liver-related clinical symptom, but simply laboratory (plasma levels greater than normal for at least one of the liver parameters -aspartate aminotransferase AST, alanine aminotransferase ALT or γ -glutamyltranspeptidase γ-GT) or instrumental (ultrasonographic abnormalities of steatosic liver) tests altered as compared to normal ranges.
Three months treatment with the nutraceutical mixture or placebo. Outcomes tested before and at the end of treatment - 3 months).
Detailed description
A correct hepatic function is highly relevant from the epidemiological point of view. In Italy, Non Alcoholic Fatty Liver Disease - NAFLD - has a prevalence of 20-25% in the adult population, with peaks of 50-70% within obese and type-2 diabetes populations: it is the most frequent cause of hematic changes in cytonecrosis enzymes, and can explain about 90% of asymptomatic high levels of transaminases. NAFLD natural history is associated with an increase of cerebro and cardiovascular risk, in both healthy subjects and diabetic patients.
Its prevention and treatment are of great interest, in particular dietary and nutraceutical interventions are the object of innovative research. It is also known that about 65% of subjects with hepatic dysfunction consume plant extracts, like silymarin from Cardo marianum. A recent trial showed an improvement of the hepatic function in subjects with NAFLD treated with silybin, combined with phosphatidylcholine and vitamin E. These findings provide valuable information on new therapeutic strategies, but warrant further investigation. For no natural substance a health claim related to liver function was in fact approved by the European Food Safety Authority (EFSA). The only exception is constituted by the food sources of choline, for which the maintenance of normal hepatic function has been claimed.
The objective of this study is to provide clinical data to support the effectiveness of a mixture of ingredients of natural origin, suitably selected and packaged, in the protection from liver damage, in subjects with NAFLD.
Treatment: subjects will be randomized to receive the nutraceutical formulation or placebo for three months, in the amount of two capsules (about 800 mg each) a day, at one time.
All subjects, after signing a written informed consent to participation in the study, will receive appropriate recomendations about diet and physical exercise.
A clinic visit, with collection of the patient clinical and pharmacological history and recording of any adverse event, liver ultrasound, measurement of weight and height and calculation of BMI, measure of arterial blood pressure, collection of a sample of venous blood, under fasting conditions, for hematochemical tests, will be made at the baseline (T0); all examinations and tests (except liver ultrasound) will be repeated after three months of treatment (T1).
Primary end-points of the study: hematic levels of hepatic enzymes: ALT, AST and γ-GT.
Secondary end-points of the study:
- Hepatic function: direct and indirect bilirubin;
- Inflammation markers: C Reactive Protein (CRP), interleukin (IL)-6, IL-1β, IL-8, IL-10, Receptor for Advanced Glycation End Products (RAGE), Advanced Glycation End Products (AGE), insulin-like growth factor-1 (IGF-1)
- Haemostatic function: Factor VII, fibrinogen, thrombin generation with and without thrombomodulin, antithrombin (AT), tissue-type Plasminogen Activator (t-PA), Plasminogen Activator Inhibitor-1(PAI-1), thrombin activatable fibrinolysis inhibitor (TAFI) and activated TAFI (TAFIa), plasmin-antiplasmin complex, plasma fibrinolytic capacity;
- Metabolic syndrome parameters: glycemia, triglycerides, HDL cholesterol, insulin e insulin-resistance (HOMA-IR homeostasis model assessment-estimated insulin resistance), adiponectin;
- Apoptosis parameters: total cytokeratin-18 (M65 antigene), M30 and M65/M65ED, soluble fas and soluble fas ligand.
A weekly food diary will be administered to each subject before and at the end of the treatment, to highlight any possible change of dietary habits during the study.
In addition, for all subjects the NAFLD Fibrosis Score (NFS), a composite score of prognostic value for the conversion of NAFDL into fibrotic hepatitis and for the disease severity, will be calculated. This score includes age, body mass index, platelet count, albumin, relationship between AST and ALT, and presence of diabetes. A sub-analysis will be done to evaluate the efficacy of the treatment with the synergistic blend of ingredients in subjects with high, as compared to those with low NFS.
Sample size calculation: Establishing Alpha = 0.05 and Β = 80%, the number of 150 people (75 per treatment arm) will evaluate differences between the two groups (T1 to T0) equal to 46% of the standard deviation of the mean of the two liver function parameters selected (primary end-points), in particular, differences over 11.5 for ALT (17% of the average), 7.1 for AST (17% of the average) or 13.8 for γ-GT (19% of the average). This calculation also includes a drop-out of 10% of the sample enrolled in the study.
Compliance to treatment will be monitored by counting the capsules returned in the box at the end of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nutraceutical mixture | Active comparator | Dietary Supplement: nutraceutical mixtureLifestyle counseling plus three month administration of nutraceutical mixture (2 soft gelatin capsules of 800 mg per day) |
| placebo | Placebo comparator | Dietary Supplement: placeboLifestyle counseling plus three month administration of placebo formulation (2 soft gelatin capsules of 800 mg per day) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- subjects with non alcoholic fatty liver disease (NAFLD)
- presenting ultrasonographic abnormalities of steatosic liver (hyperechogenic parenchyma)
- with plasma levels greater than normal (ranges of each recruiting center) for at least one of the following parameters (aspartate aminotransferase AST, alanine aminotransferase ALT, γ -glutamyltranspeptidase γ-GT).
Key exclusion criteria (9 listed)
- history of alcohol abuse
- use of drugs associated with the development of hepatic steatosis
- malnutrition
- alcoholic chronic liver disease
- chronic liver disease of different etiology (autoimmune disease, primary biliary cirrhosis, primary sclerosing cholangitis, hereditary hemochromatosis, Wilson's disease, deficits of alpha-1 antitrypsin, celiac disease)
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 |
|---|---|---|
| nutraceutical mixtureLifestyle counseling, administration of a nutraceutical mixture: fish oil 70% DHA (docosahexaenoic acid), phosphatidylcholine concentrated in sunflower oil, silymarin, choline bitartrate, curcumin, D-α-tocopherol; choline (82,5 mg, corresponding to 15% of the average intake of 550 mg per day in an adult man) | Dietary supplement | nutraceutical mixture |
| placeboLifestyle counseling, administration of a placebo, containing only choline, at the same low concentration of the active mixture | Dietary supplement | placebo |
Primary outcome
Hematic Levels of Hepatic Enzymes AST
Time frame: before and at the end of treatment (three months)
hematic levels of hepatic enzyme: aspartate aminotransferase (AST)
Hematic Levels of Hepatic Enzymes ALT
Time frame: before and at the end of treatment (three months)
hematic levels of hepatic enzyme: alanine aminotransferase (ALT)
Hematic Levels of Hepatic Enzymes GGT
Time frame: before and at the end of treatment (three months)
hematic levels of hepatic enzyme: gamma-glutamyl transpeptidase (GGT)
5 secondary outcomes
Plasma Levels of Hepatic Enzymes
Time frame: before and at the end of treatment (three months)
Levels of Circulating Inflammation Marker
Time frame: before and at the end of treatment (three months)
Measures of the Haemostatic Function
Time frame: before and at the end of treatment (three months)
Measures of the Haemostatic Function
Time frame: before and at the end of treatment (three months)
Measures of the Haemostatic Function
Time frame: before and at the end of treatment (three months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22641309Chalasani N, Younossi Z, Lavine JE, Diehl AM, Brunt EM, Cusi K, Charlton M, Sanyal AJ; American Association for the Study of Liver Diseases; American College of Gastroenterology; American Gastroenterological Association. The diagnosis and management of non-alcoholic fatty liver disease: Practice guideline by the American Association for the Study of Liver Diseases, American College of Gastroenterology, and the American Gastroenterological Association. Am J Gastroenterol. 2012 Jun;107(6):811-26. doi: 10.1038/ajg.2012.128. No abstract available.
- Individual participant dataSharing planned: No
Related trials for Non-alcoholic Fatty Liver Disease
Not yet recruiting
Efficacy of Carnitine Complex in Improving Hepatic Steatosis in Potential Liver Donors
Hepatic Steatosis, Fatty Liver
Recruiting
NAFLD Clinical Care Pathway
NAFLD, MASLD
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
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.
Giovanni de Gaetano, MD PhD principal investigator
IRCCS Neuromed
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nutraceutical mixture in people with Non-alcoholic Fatty Liver Disease, run by Neuromed IRCCS at 1 site in Italy.
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 3 inclusion and 9 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 12 Jan 2022. 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 Italy. 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 15 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?
Hematic Levels of Hepatic Enzymes AST (time frame: before and at the end of treatment (three months)). 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 NCT02369536, 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 12 Jan 2022.