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NCT01237093 · ClinicalTrials.gov registry record · Phase 1
Developing Biomarkers of Dietary Intake
A Phase 1 study of Healthy Volunteers and Diet Therapy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 1
- Development phase
- 59
- Enrollment target
- 1
- Study location
NCT01237093: Completed Phase 1 study of Healthy Volunteers and Diet Therapy, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01237093 is a Phase 1 study of Healthy Volunteers and Diet Therapy that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 59 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01237093, a Phase 1 study of Healthy Volunteers and Diet Therapy, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 59 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
Change in nitrogen stable isotope rations (N15/N14)
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 |
What the finished NCT01237093 record still lists
NCT01237093 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 59 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (88% lower).
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.
NCT01237093 reports a single indexed study location in Arizona.
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.
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).
Who is sponsoring clinical trial NCT01237093?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT01237093's enrollment target sits among peer trials
59 122nd of 283 higher than 161 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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