ObesityNCT03413735
Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
A study testing Green Tea Extract in people with Obesity and Endotoxemia, run by Ohio State University at 1 site in United States.
Trial summary
This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Endotoxemia, Inflammation
- What is being tested?
- Green Tea Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Aug 2018to 30 Jul 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Overweight/obese (BMI = 28-40 kg/m2)
- Fasting glucose < 126 mg/dL
- Normotensive (blood pressure < 140/90 mmHg)
- Non-dietary supplement user
- Non-smoker
Who cannot join
- Regular tea drinkers (> 2 cups/week)
- Vegetarians
- Use of medications to manage diabetes, hypertension, or hyperlipidemia
- Use of any medications known to be contraindicated for use with green tea ingestion
- User of dietary supplements, prebiotics, or probiotics
- Recent use of antibiotics or anti-inflammatory agents
Show all 11Show fewer
- Women who are pregnant or lactating or have initiated or changed birth control in the past 3-months
- Individuals with gastrointestinal disorders or surgeries
- Individuals with hemochromatosis
- Alcohol intake > 3 drinks per day
- Any history of cancer
Trial locations and contacts
1 site in 1 country.
About this study
This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea extract (GTE)-containing confection. These persons will then complete phase 2, which consists of a parallel design randomized controlled in which lean and obese persons will consume placebo or GTE confections.
It is expected that catechin-rich green tea will improve gut barrier function to prevent endotoxin translocation and associated low-grade inflammation. Outcomes will therefore support dietary recommendations for green tea to alleviate obesity-related inflammatory responses. Specifically, the study is expected to demonstrate that a green tea confection snack food can attenuate metabolic endotoxemia in association with restoring gastrointestinal health.
Read the detailed description
Obesity is a major public health concern in the United States, with over two-thirds of the adult population classified as overweight or obese. Obesity is characterized by low-grade chronic inflammation that, in part, is mediated by metabolic endotoxemia. Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in obesity. Studies in rodents models have shown that dietary supplementation with green tea extract (GTE) reduces metabolic endotoxemia in association with improved gut health. This clinical trial will therefore investigate the extent to which a green tea confection snack food can alleviate metabolic endotoxemia and restore gut health in obese humans. It is hypothesized that 4-week daily ingestion of a green tea extract (GTE)-rich confection will limit metabolic endotoxemia by decreasing gut barrier permeability. This study will address the following objectives: 1) define alterations in catechin pharmacokinetics in obese compared with healthy adults, 2) demonstrate improvements in gut barrier function by GTE, and 3) demonstrate GTE-mediated amelioration of microbial dysbiosis.
To test the hypothesis, all participants will initially complete a 12-h pharmacokinetics study to define the influence of obesity on catechin bioavailability and metabolism. They will then be randomized to complete a double-blind, randomized, placebo-controlled trial where they will receive a GTE-rich or placebo confection for 4 weeks. Prior to and upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory biomarkers. Upon successfully completing this study, it is anticipated that chronic consumption of a green tea confection will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia and improve gut health.
- Conditions
- Obesity, Endotoxemia, Inflammation
- Being tested
- Green Tea Extract, Placebo
- Medical subject headings
- Obesity, Endotoxemia, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Green Tea ExtractOther
Confections containing green tea extract that will be ingested daily for 4 weeks
PlaceboOther
Confections containing no green tea extract that will be ingested daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Placebo Confection | Placebo comparator | Confection without green tea extract consumed daily for 4 weeks Receives: Other: Placebo |
| Green Tea Extract-Confection | Experimental | Confection with green tea extract consumed daily for 4 weeks Receives: Other: Green Tea Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endotoxin
Serum endotoxin concentration
Measured: Week 0 - Fasting
Endotoxin
Serum endotoxin concentration
Measured: Week 2 - Fasting
Endotoxin
Serum endotoxin concentration
Measured: Week 4 - Fasting
Secondary outcomes (24)
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Measured: Week 0 - 0-5 hours
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Measured: Week 0 - 6-24 hours
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Measured: Week 4 - 0-5 hours
Gut Permeability - Lactulose to Mannitol Ratio
Urinary Lactulose/Mannitol Ratio (mg/mg)
Measured: Week 4 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol Ratio (mg/mg)
Measured: Week 0 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol Ratio (mg/mg)
Measured: Week 0 - 0-24 hours
Urinary Sucralose/Erythritol Ratio (mg/mg)
Ratio of excretion of urinary sugars (Sucralose to Erythritol)
Measured: Week 4 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Urinary Sucralose/Erythritol Ratio (mg/mg)
Measured: Week 4 - 0-24 hours
Firmicutes to Bacteroidetes Ratio - Microbiota
Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)
Measured: Week 0
Firmicutes to Bacteroidetes Ratio - Microbiota
Ratio of fecal relative Firmicutes (% abundance)/Bacteroidetes (% abundance)
Measured: Week 4
Bioavailability - Epigallocatechin Gallate
Area under the curve (AUC) of plasma epigallocatechin calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin gallate is measured in umol/L over time (hours) resulting in the AUC.
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epigallocatechin
Area under the curve (AUC) of plasma epigallocatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epigallocatechin is measured in umol/L over time (hours) resulting in the AUC.
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epicatechin Gallate
Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechins is measured in umol/L over time (hours) resulting in the AUC.
Measured: Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epicatechin
Area under the curve (AUC) of plasma epicatechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection. Epicatechin is measured in umol/L over time (hours) resulting in the AUC.
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Cmax of Epigallocatechin Gallate
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epigallocatechin
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epicatechin Gallate
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epicatechin
Maximum plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epigallocatechin Gallate
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epigallocatechin
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epicatechin Gallate
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epicatechin
Time to maximal plasma concentration of catechins calculated from blood collected at 0, 0.25, 0.5, 1, 2, 3, 5, 8, 10, 12 hours post-ingestion of green tea confection
Measured: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Calprotectin
Fecal calprotectin concentration
Measured: Week 0
Calprotectin
Fecal calprotectin concentration
Measured: Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start29 Aug 2018
- Primary completion30 Jul 2019
- Study completion30 Jul 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 (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Bruno, Ohio State University
- Investigators
- Richard Bruno, PhD, RD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413735
- Sponsor's protocol ID
- 2017H0246
- Status last verified
- May 2025
- First submitted
- 22 Jan 2018
- Last updated
- 13 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.
Publications
Li J, Sapper TN, Mah E, Moller MV, Kim JB, Chitchumroonchokchai C, McDonald JD, Bruno RS. Green tea extract treatment reduces NFkappaB activation in mice with diet-induced nonalcoholic steatohepatitis by lowering TNFR1 and TLR4 expression and ligand availability. J Nutr Biochem. 2017 Mar;41:34-41. doi: 10.1016/j.jnutbio.2016.12.007. Epub 2016 Dec 21.
PubMed 28038359Li J, Sasaki GY, Dey P, Chitchumroonchokchai C, Labyk AN, McDonald JD, Kim JB, Bruno RS. Green tea extract protects against hepatic NFkappaB activation along the gut-liver axis in diet-induced obese mice with nonalcoholic steatohepatitis by reducing endotoxin and TLR4/MyD88 signaling. J Nutr Biochem. 2018 Mar;53:58-65. doi: 10.1016/j.jnutbio.2017.10.016. Epub 2017 Nov 3.
PubMed 29190550
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Green Tea Confection For Resolving Gut Permeability-Induced Metabolic Endotoxemia In Obese Adults
- ClinicalTrials.gov ID
- NCT03413735
- Acronym / sponsor ID
- 2017H0246
- Conditions
- Obesity, Endotoxemia, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 29 Aug 2018 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Jul 2019 (actual)
- First posted
- 29 Jan 2018 (actual)
- Results
- Posted 13 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is focused on assessing gastrointestinal-level improvements by which green tea limits metabolic endotoxemia. It is completed in two phases. Phase I consists of a pharmacokinetic study to examine the bioavailability of green tea catechins among lean and obese persons who consumed a single dose of a green tea extract (GTE)-containing confection. These persons will then complete phase 2, which consists of a parallel design randomized controlled in which lean and obese persons will consume placebo or GTE confections.
It is expected that catechin-rich green tea will improve gut barrier function to prevent endotoxin translocation and associated low-grade inflammation. Outcomes will therefore support dietary recommendations for green tea to alleviate obesity-related inflammatory responses. Specifically, the study is expected to demonstrate that a green tea confection snack food can attenuate metabolic endotoxemia in association with restoring gastrointestinal health.
Detailed description
Obesity is a major public health concern in the United States, with over two-thirds of the adult population classified as overweight or obese. Obesity is characterized by low-grade chronic inflammation that, in part, is mediated by metabolic endotoxemia. Metabolic endotoxemia describes increased circulating levels of gut-derived endotoxin (a bacterial product derived from Gram-negative bacteria in the intestines) that results from gut barrier dysfunction, a phenomenon that is common in obesity. Studies in rodents models have shown that dietary supplementation with green tea extract (GTE) reduces metabolic endotoxemia in association with improved gut health. This clinical trial will therefore investigate the extent to which a green tea confection snack food can alleviate metabolic endotoxemia and restore gut health in obese humans. It is hypothesized that 4-week daily ingestion of a green tea extract (GTE)-rich confection will limit metabolic endotoxemia by decreasing gut barrier permeability. This study will address the following objectives: 1) define alterations in catechin pharmacokinetics in obese compared with healthy adults, 2) demonstrate improvements in gut barrier function by GTE, and 3) demonstrate GTE-mediated amelioration of microbial dysbiosis.
To test the hypothesis, all participants will initially complete a 12-h pharmacokinetics study to define the influence of obesity on catechin bioavailability and metabolism. They will then be randomized to complete a double-blind, randomized, placebo-controlled trial where they will receive a GTE-rich or placebo confection for 4 weeks. Prior to and upon completing the intervention, participants will undergo a gut permeability test, fecal samples will be collected for microbiota composition analysis, and blood samples will be collected to assess endotoxin and inflammatory biomarkers. Upon successfully completing this study, it is anticipated that chronic consumption of a green tea confection will be demonstrated to be an effective dietary strategy to reduce metabolic endotoxemia and improve gut health.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo Confection | Placebo comparator | Other: PlaceboConfection without green tea extract consumed daily for 4 weeks |
| Green Tea Extract-Confection | Experimental | Other: Green Tea ExtractConfection with green tea extract consumed daily for 4 weeks |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Overweight/obese (BMI = 28-40 kg/m2)
- Fasting glucose < 126 mg/dL
- Normotensive (blood pressure < 140/90 mmHg)
- Non-dietary supplement user
- Non-smoker
Key exclusion criteria (11 listed)
- Regular tea drinkers (> 2 cups/week)
- Vegetarians
- Use of medications to manage diabetes, hypertension, or hyperlipidemia
- Use of any medications known to be contraindicated for use with green tea ingestion
- User of dietary supplements, prebiotics, or probiotics
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 |
|---|---|---|
| Green Tea ExtractConfections containing green tea extract that will be ingested daily for 4 weeks | Other | Green Tea Extract-Confection |
| PlaceboConfections containing no green tea extract that will be ingested daily for 4 weeks | Other | Placebo Confection |
Primary outcome
Endotoxin
Time frame: Week 0 - Fasting
Serum endotoxin concentration
Endotoxin
Time frame: Week 2 - Fasting
Serum endotoxin concentration
Endotoxin
Time frame: Week 4 - Fasting
Serum endotoxin concentration
24 secondary outcomes
Gut Permeability - Lactulose to Mannitol Ratio
Time frame: Week 0 - 0-5 hours
Gut Permeability - Lactulose to Mannitol Ratio
Time frame: Week 0 - 6-24 hours
Gut Permeability - Lactulose to Mannitol Ratio
Time frame: Week 4 - 0-5 hours
Gut Permeability - Lactulose to Mannitol Ratio
Time frame: Week 4 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Time frame: Week 0 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Time frame: Week 0 - 0-24 hours
Urinary Sucralose/Erythritol Ratio (mg/mg)
Time frame: Week 4 - 6-24 hours
Gut Permeability - Sucralose to Erythritol Ratio
Time frame: Week 4 - 0-24 hours
Firmicutes to Bacteroidetes Ratio - Microbiota
Time frame: Week 0
Firmicutes to Bacteroidetes Ratio - Microbiota
Time frame: Week 4
Bioavailability - Epigallocatechin Gallate
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epigallocatechin
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epicatechin Gallate
Time frame: Prior to the intervention enrollment...0-12 hours post-ingestion of a green tea confection
Bioavailability - Epicatechin
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of a green tea confection
Cmax of Epigallocatechin Gallate
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epigallocatechin
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epicatechin Gallate
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Cmax of Epicatechin
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epigallocatechin Gallate
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epigallocatechin
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epicatechin Gallate
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Tmax of Epicatechin
Time frame: Prior to intervention enrollment...0-12 hours post-ingestion of green tea confection
Calprotectin
Time frame: Week 0
Calprotectin
Time frame: Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28038359Li J, Sapper TN, Mah E, Moller MV, Kim JB, Chitchumroonchokchai C, McDonald JD, Bruno RS. Green tea extract treatment reduces NFkappaB activation in mice with diet-induced nonalcoholic steatohepatitis by lowering TNFR1 and TLR4 expression and ligand availability. J Nutr Biochem. 2017 Mar;41:34-41. doi: 10.1016/j.jnutbio.2016.12.007. Epub 2016 Dec 21.
- Background: PubMed 29190550Li J, Sasaki GY, Dey P, Chitchumroonchokchai C, Labyk AN, McDonald JD, Kim JB, Bruno RS. Green tea extract protects against hepatic NFkappaB activation along the gut-liver axis in diet-induced obese mice with nonalcoholic steatohepatitis by reducing endotoxin and TLR4/MyD88 signaling. J Nutr Biochem. 2018 Mar;53:58-65. doi: 10.1016/j.jnutbio.2017.10.016. Epub 2017 Nov 3.
- Individual participant dataSharing planned: No. Data will be published as aggregate only. Data sharing may be possible pending institutional agreements.
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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.
Richard Bruno, PhD, RD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Green Tea Extract in people with Obesity and Endotoxemia, run by Ohio State University 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 5 inclusion and 11 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 13 Jun 2025. 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?
Yes. Results are posted in the registry (first posted 13 Jun 2025). 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?
Endotoxin (time frame: Week 0 - Fasting). 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 NCT03413735, which also lists 2 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 13 Jun 2025; AzTrials last refreshed its copy on 6 Nov 2026.