NCT02471300|Completed
Effect of Fasting on the Asthma Inflammasome
Pilot Study to Evaluate the Effect of Fasting on the Asthma Inflammasome
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Pilot Study to Evaluate the Effect of Fasting on the Asthma Inflammasome
Sponsor study identifier
Secondary identifiers
observational
19
1 country
1
Study Start
August 26, 2015
Actual (reported)Primary Completion
March 6, 2017
Actual (reported)Study Completion
January 27, 2021
Actual (reported)Background: Research shows that restricting calories has a positive effect on immune cell health in healthy people. Researchers want to learn if it will help people with asthma. They want to better understand how the body s immune response and lung function responds to short-term calorie restriction. For this, they want people to fast (no food or drink except water) for 24 hours. Objective: To explore the benefits of calorie restriction in people with asthma. Eligibility: Healthy people ages 18 to 60 who have a history consistent with asthma and prior documentation of airflow obstruction or wheezing. Design:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 27, 2021
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 12, 2015
Actual (reported)June 15, 2015
Actual (reported)August 26, 2015
Actual (reported)March 6, 2017
Actual (reported)January 27, 2021
Actual (reported)Change in IL-1-beta secretion in response to inflammasome stimulation in PBMCs comparing the fasted response to the fed response
Determine whether the NLRP3 inflammasome is blunted by a 24-hour fast in PBMC s in subjects with mild to moderate asthma.Initiate 24-hour fast with the exception of drinking water and use of asthma medications until midnight. Patients will be asked to hold their asthma medications after midnight. Fasting research labs to study the inflammasome and Fed State Research Labs to study the inflammasome.
24 hours
stable mild-moderate asthmatic subjects
-Males and females between the ages of 18 and 60@@@-Asthmatic subjects will have a history consistent with asthma, be on chronic asthma therapy and have prior documentation of reversible airflow obstruction based upon either a positive response to an inhaled bronchodilator or a positive methacholine broncho-provocation challenge test@@@@@@
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892, United States
Besnard AG, Guillou N, Tschopp J, Erard F, Couillin I, Iwakura Y, Quesniaux V, Ryffel B, Togbe D. NLRP3 inflammasome is required in murine asthma in the absence of aluminum adjuvant. Allergy. 2011 Aug;66(8):1047-57. doi: 10.1111/j.1398-9995.2011.02586.x. Epub 2011 Mar 28.
Kim SR, Kim DI, Kim SH, Lee H, Lee KS, Cho SH, Lee YC. NLRP3 inflammasome activation by mitochondrial ROS in bronchial epithelial cells is required for allergic inflammation. Cell Death Dis. 2014 Oct 30;5(10):e1498. doi: 10.1038/cddis.2014.460.
Michael N Sack, M.D.
National Heart, Lung, and Blood Institute (NHLBI)
19 participants (actual enrollment reported by the registry).
First Submitted
June 12, 2015
First Posted
June 15, 2015
Study Start
August 26, 2015
Actual (reported)Contact the study team to confirm eligibility.
Kim HY, Lee HJ, Chang YJ, Pichavant M, Shore SA, Fitzgerald KA, Iwakura Y, Israel E, Bolger K, Faul J, DeKruyff RH, Umetsu DT. Interleukin-17-producing innate lymphoid cells and the NLRP3 inflammasome facilitate obesity-associated airway hyperreactivity. Nat Med. 2014 Jan;20(1):54-61. doi: 10.1038/nm.3423. Epub 2013 Dec 15.
Primary Completion
March 6, 2017
Actual (reported)Study Completion
January 27, 2021
Actual (reported)Last Updated
February 1, 2021
Record last verified: 2021-01
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