Effect of Fasting on the NLRP3 Inflammasome

NCT02122575 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23

Last updated 2021-02-01

No results posted yet for this 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.

Conditions

Sponsors & Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

    lead NIH

Principal Investigators

  • Michael N Sack, M.D. · National Heart, Lung, and Blood Institute (NHLBI)

Eligibility

Min Age
21 Years
Max Age
37 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-21
Primary Completion
2017-03-06
Completion
2021-01-27

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02122575 on ClinicalTrials.gov