Effect of Fasting on the NLRP3 Inflammasome
Completed
Conditions studied: Cardiovascular Disease, Inflammatory Disease
In brief
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.
Key facts
- Study ID
- NCT02122575
- Run by
- National Heart, Lung, and Blood Institute (NHLBI)
- People needed
- 23
- Starts
- 2014-04-21
- Expected to finish
- 2021-01-27
- Last updated by the study team
- 2021-02-01
Who can join
Age: 21 and older, up to 37. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- Subjects with an acute or chronic illness as per history, on laboratory analysis or due to use of medications
- Subjects taking vitamins or supplements or any medications, except oral contraceptives within 4 weeks of participation into this study.
- BMI <23.5 or >29
- Female subjects who are pregnant or lactating
- Subjects who have donated blood or participated in another clinical trial involving blood draws in the last 8 weeks.
- Subjects who use nicotine products
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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