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Developing Biomarkers of Dietary Intake
NCT01237093 · View on ClinicalTrials.gov ↗
Study Summary
Background: \- Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In particular, better methods are needed to determine if people are accurately remembering what they ate. One possible method involves the use of biomarkers, or indicators in urine, blood, saliva, fat, and hair, which are related to the intake of a particular food in a consistent way. One set of biomarkers in blood samples and hair may be used to determine the relative amount of meat, fish, and soda (corn/sugar cane) in a person s diet. However, more research is needed to study the effectiveness of using these biomarkers to accurately track dietary intake. Objectives: \- To validate the use of biomarkers as representative of specific dietary intake patterns (meat/fish/soda). Eligibility: \- Healthy, nondiabetic men between 18 and 65 years of age. Design: * This study involves an initial screening visit and a 12-13 week inpatient dietary study period. * Participants will be screened with a medical history and physical examination, as well as blood and urine samples and a glucose tolerance test to exclude individuals who have diabetes. * After 3 days of a standard weight-maintaining diet, participants will have a glucose tolerance test and a body fat scan; provide hair, blood, and fat tissue samples; and complete questionnaires and performance tests. * Participants will spend one day in a metabolic chamber to measure their energy expenditure and general metabolism. * Participants will then be randomized into one of eight carefully designed diets for 12 weeks. The diets will differ in the amount of meat, fish, and soda, including one diet where none of the three biomarker-related foods will be permitted. Blood samples will be collected throughout the study diet period. * At the end of the 12-week study diet period, participants will provide additional hair, blood, and
Conditions Studied
Interventions
- OTHER 1. Meat, no fish or soda
- OTHER 2. Meat and soda, no fish
- OTHER 3. Meat and fish, no soda
- OTHER 4. Meat and fish and soda
- OTHER 5. Fish, no meat or soda
Study Locations (1)
Arizona
- NIDDK, Phoenix — Phoenix
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 59 participants |
| Start Date | 2010-10-24 |
| Est. Completion | 2020-03-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01237093
The ClinicalTrials.gov registry entry for NCT01237093 describes a study currently listed as completed. It is categorized as Phase 1, 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 59 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 2 conditions, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions — of which 1. Meat, no fish or soda is the first listed. 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: NCT01237093 reports 1 study location spanning 1 distinct geographic area — top geographies include Arizona. 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 NCT01237093 about?
NCT01237093 is a clinical study titled "Developing Biomarkers of Dietary Intake". Background: \- Researchers who study health and nutrition are interested in developing more accurate methods of determining what people eat from day to day and how it affects their general health. In particular, better methods are needed to determine if people are accurately remembering what they a...
What is the current status of trial NCT01237093?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 59 participants. The study started on 2010-10-24. Estimated completion is 2020-03-31.
What conditions does trial NCT01237093 study?
This clinical trial studies the following conditions: Healthy Volunteers, Diet Therapy. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT01237093?
The interventions under investigation include: 1. Meat, no fish or soda (OTHER), 2. Meat and soda, no fish (OTHER), 3. Meat and fish, no soda (OTHER), 4. Meat and fish and soda (OTHER), 5. Fish, no meat or soda (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT01237093?
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 NCT01237093 being conducted?
This trial has 1 study location across Arizona. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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