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NCT03189121 · ClinicalTrials.gov registry record
Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity
A clinical trial, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- 5
- Enrollment target
NCT03189121: Completed study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT03189121 is a clinical trial that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03189121 has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- 5 participants
- Enrollment target
Study Summary
Background: Increases in obesity, diabetes, and some metabolic disorders may be linked to how much processed foods people eat. Researchers want to learn more about how processed foods affect metabolic health. Objective: To learn about how a processed versus unprocessed diet affects the body. Eligibility: Men ages 18-50 with stable weight and risk factors for diabetes Design: Participants will be screened over 3 visits. Screening includes: * Medical history and physical exam * Heart and blood tests * Psychiatric questions * Questions about eating, sleeping, and economic status * Riding a stationary bike * Trying a sample meal Between screenings, participants will eat prepared meals. They will wear an accelerometer to measure physical activity. They will write down what foods they eat and monitor their weight. Participants will have two 4-week stays in the clinic. They will: * Eat a special diet * Have activity and weight monitored * Drink water and collect urine samples to measure how many calories they are burning * Have resting energy expenditure measured with a clear hood over the head * Have a scan to measure body fat and bone density using low-dose x-rays * Have a scan on a table that slides into a metal cylinder in a strong magnetic field. They will get earplugs for the loud noises. * Have an ultrasound test to measure blood vessels * Have insulin and glucose infused into an arm vein. Blood will be taken over 10 hours through a plastic tube in the wrist. This will happen 4 times. * Spend multiple 24-hour periods in a room that measures oxygen used and carbon dioxide produced. * Give blood, urine and stool samples * Answer questionnaires and do computer tasks
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2017-11-20 |
| Est. Completion | 2019-04-05 |
What the finished NCT03189121 record still lists
NCT03189121 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 5 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT03189121 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03189121 about?
NCT03189121 is a clinical study titled "Effect of Isocaloric Ultra Processed Versus Unprocessed Diets on Insulin Sensitivity". Background: Increases in obesity, diabetes, and some metabolic disorders may be linked to how much processed foods people eat. Researchers want to learn more about how processed foods affect metabolic health. Objective: To learn about how a processed versus unprocessed diet affects the body. Eli...
What is the current status of trial NCT03189121?
This trial is currently completed. The enrollment target is 5 participants. The study started on 2017-11-20. Estimated completion is 2019-04-05.
Who is sponsoring clinical trial NCT03189121?
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.
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