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Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease (NAFLD)
NCT02363309 · View on ClinicalTrials.gov ↗
Study Summary
Background: \- Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver tests. It is closely linked to health problems like obesity and diabetes. Researchers want to use a breath test to measure the metabolism of fatty acids and learn more about the causes of disease. They will compare the results between people who do and do not have NAFLD. They will also repeat the test in people with NAFLD after treatment to see improvement. Objectives: \- To measure the metabolism of fatty acids and compare them between people who do and do not have NAFLD, and people with NAFLD before and after treatment. Eligibility: * People age 21 and older with NAFLD * Healthy volunteers * non-NAFLD metabolic syndrome Design: * Participants will be screened with medical history, physical exam, and fasting blood tests. * Participants will fast overnight. * Participants will sit in a comfortable chair. They will relax for 15 minutes. Then a narrow plastic tube will be put under their nostrils. It will be connected to a breath test device. * Participants will drink palmitate or acetate in a heated liquid meal (Ensure). Palmitate is a fatty acid and acetate is a small molecule that is a building block for fatty acids. Both palmitate and acetate are natural compounds that are in our body and our food. * Participants will sit for 6 hours. They can read, watch television, work on a computer, or other relaxed activity. The air they breathe out from their nose will be collected and analyzed. They may take a bathroom break after 3 hours. They may drink water after 3 hours. * Participants will get a meal after the test. * Participants will have another visit at least 1 week later. They will repeat the test with the other compound (acetate of palmitate). * Participants may be asked to repeat a test to study the result of a change like weight loss or medicine. Thus, participation can last from 1 week to several years.
Conditions Studied
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 74 participants |
| Start Date | 2015-03-27 |
| Est. Completion | 2018-11-29 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02363309
The ClinicalTrials.gov registry entry for NCT02363309 describes a study currently listed as completed. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 74 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Fatty Liver appearing as the primary indexed condition, and to 0 interventions. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02363309 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT02363309 about?
NCT02363309 is a clinical study titled "Palmitate Breath Test to Assess Fatty Acid Oxidation in Non Alcoholic Fatty Liver Disease (NAFLD)". Background: \- Non-alcoholic fatty liver disease (NAFLD) is a common cause of abnormal liver tests. It is closely linked to health problems like obesity and diabetes. Researchers want to use a breath test to measure the metabolism of fatty acids and learn more about the causes of disease. They will...
What is the current status of trial NCT02363309?
This trial is currently completed. The enrollment target is 74 participants. The study started on 2015-03-27. Estimated completion is 2018-11-29.
What conditions does trial NCT02363309 study?
This clinical trial studies the following conditions: Fatty Liver. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
Who is sponsoring clinical trial NCT02363309?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 375 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT02363309 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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