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NCT02122575 · ClinicalTrials.gov registry record
Effect of Fasting on the NLRP3 Inflammasome
A clinical trial, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- Completed
- Registry status
- 23
- Enrollment target
NCT02122575: Completed study, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
NCT02122575 is a clinical trial that has completed, run by National Heart, Lung, and Blood Institute (NHLBI). The registered enrollment target is 23 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02122575 has completed, sponsored by National Heart, Lung, and Blood Institute (NHLBI).
- COMPLETED
- Registry status
- 23 participants
- Enrollment target
Study Summary
Background: \- Restricting calories can help a person reduce risk factors for heart disease. Researchers have found that not eating or drinking anything but water for 24 hours prevents the activation of a component of the immune system, called the inflammasome. The inflammasome is associated with the development of diabetes and heart disease. Researchers want to learn more about the body s response to fasting. Objective: \- To explore the benefits of calorie restriction on heart health. Eligibility: \- Healthy adults ages 21 32 with a body mass index between 26 and 29. Design: * Participants will be screened with a medical history, physical exam and blood test. * Participants will not eat or drink after 10 p.m. before their first visit. * Participants have breakfast at the clinic. The breakfast will be about 500 calories. Then they will not eat or drink (except water) for 24 hours. * Participants will return to the clinic the next morning. They will have blood drawn. Then they will have breakfast. Blood will be drawn again at 1 hour and 3 hours after the meal. * Blood and urine tests at the end of the fast and following the meals will be done to confirm that participants have fasted for the full 24-hour period.
Primary Outcome
The primary outcome will be the change in IL-1 secretion in response to inflammasome stimulation in PBMC s comparing the fasted response to the fed response. As there are two fed responses, we will initially determine whether inflammasome induction differs between the peak post- prandial insulin effect (1 hr) and the peak post-prandial fatty acid levels (3 hr). The higher mean IL-1 levels between the two fed states will be considered the index fed response and will be compared to the fasting lev
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 23 participants |
| Start Date | 2014-04-21 |
| Est. Completion | 2021-01-27 |
What the finished NCT02122575 record still lists
NCT02122575 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 23 participants, a relatively small participant target.
The record links to 0 conditions, and to 0 interventions.
NCT02122575 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02122575 about?
NCT02122575 is a clinical study titled "Effect of Fasting on the NLRP3 Inflammasome". Background: \- Restricting calories can help a person reduce risk factors for heart disease. Researchers have found that not eating or drinking anything but water for 24 hours prevents the activation of a component of the immune system, called the inflammasome. The inflammasome is associated with t...
What is the current status of trial NCT02122575?
This trial is currently completed. The enrollment target is 23 participants. The study started on 2014-04-21. Estimated completion is 2021-01-27.
Who is sponsoring clinical trial NCT02122575?
This trial is sponsored by National Heart, Lung, and Blood Institute (NHLBI), which has 501 total clinical trials registered on ClinicalTrials.gov.
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